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 Claims
Claims 16-32 are pending and 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 19 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.
Specifically, Claim 19 recites “especially,” which is a term that renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For prior art examination, Examiner ignores the clause following “especially.”
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.
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.
Claims 16-32 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 2012/0109034) in view of Long et al. (US 2020/0282114) and Heppe (US 2018/0049667).
Re Claim 16, Locke discloses a wound dressing comprising:
(a) cover layer (sealing member 120),
(b) at least one foam-containing layer (distribution manifold 118, [0029] “distribution manifold 118 is a porous foam … may be a polyurethane, open-cell, reticulated foam”), and
(d) at least one sensor (126 or 142, see Fig. 3).
Locke does not disclose (c) wound-contact layer. Long discloses a negative pressure wound treatment dressing similar to that of Locke, having an open-cell manifold layer (46, Fig. 3) and a sealing layer (74), wherein the Long dressing further includes a wound-contact layer (26). It would have been obvious to one skilled in the art at the time of filing to modify Locke with the addition of a wound-contact layer as such layers are known in the field to be more suitable for interacting with wound tissues.
Locke also does not disclose that the at least one sensor is contained in at least one textile-based fabric. Heppe discloses a textile-based fabric sensor (6 or 7, Abstract) designed to be placed onto the skin or wound of a patient, wherein the sensor comprises conductive warp and/or weft threads. It would have been obvious to one skilled in the art at the time of filing to modify Locke with the fabric sensor taught by Heppe because such sensors are more flexible and are better at adapting to the contours of a wound.
Re Claim 17, Locke, Long and Heppe combine to disclose claim 16, and Locke also discloses wherein the cover layer is a film ([0031]) or a textile-based fabric.
Re Claim 18, Locke, Long and Heppe combine to disclose claim 16, and Locke further discloses wherein the foam is an absorbent foam ([0029]).
Re Claim 19, Locke, Long and Heppe combine to disclose claim 16, and Locke further discloses wherein the foam is a polyurethane foam ([0029]).
Re Claim 20, Locke, Long and Heppe combine to disclose claim 16, and in the combination, Long further discloses wherein the wound-contact layer comprises a silicone ([0075] or [0077] of Long).
Re Claim 21, Locke, Long and Heppe combine to disclose claim 16, and in the combination, Heppe further discloses wherein the at least one sensor contained in the at least one textile-based fabric is a conductive thread and/or a conductive filament (Abstract in Heppe).
Re Claim 22, Locke, Long and Heppe combine to disclose claim 21, and Locke further discloses wherein the conductive thread includes an insulated wire made of a conductive material ([0038] of Heppe), and/or the conductive filament comprises a conductive polymer.
Re Claim 23, Locke, Long and Heppe combine to disclose claim 16, and in the combination, Heppe further discloses wherein the at least one sensor contained in the at least one textile-based fabric is arranged in an ordered structure in the textile-based fabric (e.g., see Fig. 1 and [0035] in Heppe).
Re Claim 24, Locke, Long and Heppe combine to disclose claim 16, and in the combination, Heppe further discloses wherein the at least one sensor contained in the at least one textile-based fabric separately measures the presence of fluid (Abstract, “One of the two sensors 6, 7 is a moisture sensor”), the temperature and/or the pH.
Re Claim 25, Locke, Long and Heppe combine to disclose claim 16, but Locke does not disclose wherein the wound dressing includes two foam-containing layers. Long discloses a dressing having two absorbent manifolds (46, see Fig. 1), wherein the manifolds can be made of foam ([0078]). It would have been obvious to one skilled in the art at the time of filing to modify further with Long’s teaching of two layers of foam as this may allow for more flexibility in determining the dressing characteristics (e.g., the layers of foam may be made of the exact same materials or different materials and thus different material properties).
Re Claim 26, Locke, Long and Heppe combine to disclose claim 16, and Locke further discloses wherein the at least one sensor contained in the at least one textile-based fabric is arranged between the cover layer and the foam-containing layer (see Fig. 3 where the sensor would be in direct contact or partially embedded into the distribution manifold), in the foam-containing layer, between two foam-containing layers and/or between the foam-containing layer and the wound-contact layer.
Re Claim 27, Locke, Long and Heppe combine to disclose claim 16, but none discloses wherein the wound-contact layer includes at least one sensor contained in the at least one textile-based fabric. However, a person of ordinary skill has good reason to pursue the known options (putting the sensor immediately adjacent the wound, in between various layers within the dressing, or on top of the cover of the dressing) within his or her technical grasp. If this leads to the anticipated success (the user is able to track/detect a characteristic/property of the wound/dressing), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Re Claim 28, Locke, Long and Heppe combine to disclose claim 16, and the combination further discloses comprising
(a) a film as a cover layer ([0031] in Locke),
(b) an absorbent foam as a foam-containing layer ([0029] in Locke),
(c) a silicone as a wound-contact layer ([0077] or [0075] in Long), and
(d) a textile-based fabric containing a sensor (already discussed in rejection of Claim 16 as being taught by Heppe).
Re Claim 29, Locke, Long and Heppe combine to disclose claim 16, and the combination further discloses comprising
(a) a polyurethane film as a cover layer ([0031] in Locke),
(b) a polyurethane foam as a foam-containing layer ([0029] in Locke),
(c) a silicone layer as the wound-contact layer ([0077] or [0075] in Long), and
(d) a warp-knit fabric containing a sensor (Abstract of Heppe).
Re Claim 31, Locke, Long and Heppe combine to disclose claim 16, comprising
(a) a polyurethane film as a cover layer ([0031] in Locke),
(b) a polyurethane foam as a foam-containing layer ([0029] in Locke),
(c) a silicone layer as the wound-contact layer ([0077] or [0075] in Long), and
(d) a warp-knit fabric containing a sensor (Abstract of Heppe).
None of the references expressly discloses wherein the warp-knit fabric containing a sensor is arranged between the foam-containing layer and the wound-contact layer. However, a person of ordinary skill has good reason to pursue the known options (putting the sensor immediately adjacent the wound, in between various layers within the dressing, or on top of the cover of the dressing) within his or her technical grasp. If this leads to the anticipated success (the user is able to track/detect a characteristic/property of the wound/dressing), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Re Claims 30 & 32, Locke, Long and Heppe combine to disclose claim 29 or 31, and in the combination, Long further discloses a silicone mesh as the wound-contact layer ([0075], [0077], given that the silicone sound-contact layer 26 has many apertures 38, it is broadly interpreted to be a mesh).
Conclusion
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/SUSAN S SU/Primary Examiner, Art Unit 3781 4 June 2026
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