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 .
Election/Restrictions
Applicant’s election without traverse of Group I (1, 3 and 5-21) in the reply filed on 02/18/2026 is acknowledged.
Claims 22-46, 73 and 74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/18/2026.
Claims 1, 3 and 5-21 are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “that is trimmable” which renders the claim indefinite as it is not clear what “that” is referring to. In an effort to compact prosecution, the limitation is being interpreted as “the device is trimmable”
Claim Objections
Claims 10 and 11 are objected to because of the following informalities:
Claim 10 line 3 recites “a first end” which should read “the first end”
Claim 11 line 3 recites “a second end” which should read “the first end”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 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 (figure 1 and [0449, 0495-508], wound3 dressing 2 comprising stacks of manifold illustrated figures 10a-c) for use in negative pressure wound therapy, the device comprising:
a flexible body (figures 11a-c [0105] the dressing made of flexible material comprising manifold stack 120) having a plurality of spacers (figure 10a, layers 121-125), the spacers configured to define a therapy space between a wound surface and a wound facing surface of the device body (figure 10a, the manifold stack 120 is configured to disposed within wound chamber under backing layer 3 and defines a therapy space);
an inlet (figures 1, 10a-c [0498] connection at one edge 127 of the layer 122 for mating end of a fluid inlet tube 6) for the instillation of fluids to a wound site; and
an outlet (figures 1, 10a-c [0502] connection at opposite edge 132 of the layer 124 for matting end of a fluid outlet tube 9) 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 (figures 10a-c and [0498] the inlet is configured to deliver fluid to an area adjacent the edge 127), and the outlet is configured to remove fluid from an area adjacent to a second, opposite, end of the device (figures 10a-c and [0502] the outlet is configured to remove fluid from an area adjacent the opposite edge 132).
Regarding claim 3, Blott teaches a wound interface device as claimed in claim 1.
Blott further teaches wherein the spacers define multiplicity of channels (figure 10a, stacks of layers 121-125 defines multiple channels along the slots 128 and 131 between the edges 127 and 132) between the first and second ends of the device;
wherein the channels are shaped to direct fluids laterally across the wound surface between the first and second ends of the device (figure 10a and [0495] the slots are configured to guide fluid in a lateral direction across the wound surface and between the opposing edges 127 and 132 ).
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 [0162 and 0498] inlet pipe 6 in form of a port for connection as a female member for mating fluid supply tube 7) for coupling to a fluid source; and
an inlet channel (figure 10a and [0489], a fluid channel defined in slot 126 is in fluid communication with the inlet port and configured to deliver fluid to the area adjacent the edge 127) in fluid communication with the inlet port, 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] outlet pipe 9 in form of a port for connection as a female member for mating diaphragm vacuum pump 18 through 10) for coupling to a negative pressure source; and
an outlet channel (figure 10a and [0502] a channel defined in slot 131 is in fluid communication with the outlet port and is configured to remove fluid from the area adjacent 132) 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 (figure 10a, branches 128 of the inlet channel extend in perpendicular to the edge 126), and the outlet channel extends in a second direction (figure 10a, portion of slot 131 extend along edge 132 is perpendicular to the first 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 (figure 10a, the slot 131 extends along transverse direction of stack of layers 120).
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 (figure 10a, the slot 131 being elongated along edge 132 which allows the ingress of fluid from the therapy space into the outlet channel) 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 (figure 10a, the slot 131 extends along transverse direction of the stacks of layers 120).
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 (figure 10a [0504] apertures 135 allows the ingress of fluid from wound chamber 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
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 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 preventing obstruction of fluid flow through the fluid channels by adjacent spacers 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 preventing obstruction of fluid flow through the fluid channels by adjacent spacers 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).
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over Blott et al (US 20110213319 A1) in view of Robinson et al (US 20220016331 A1)
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 negative pressure wound therapy system, Robinson teaches wherein the body is liquid and air impermeable ([0056] drape 132 is liquid/gas impermeable).
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 providing a fluid sealed therapeutic environment for negative wound pressure treatment thereby promoting wound healing as taught by Robinson ([0055]) .
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kagan (US 20100160877 A1) and Rice (US 20210113748 A1)
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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