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 Claims 44-50, 52-56, and 58 in the reply filed on 10/24/2025 is acknowledged.
Claims 1-2, 7, 19, 24-25, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/24/2025.
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 44-45 and 47-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rehbein et al. (US 20220183895 A1), hereinafter referred to as “Rehbein”.
Regarding Claim 44, Rehbein teaches an apparatus for distributing force across a tissue site (wound dressing 124 across tissue site 104, see Figure 1 and 10B; one example embodiment may be readily applicable to other example embodiments, see Paragraph [0091]), comprising:
a thermoformed layer (fluid management assembly 144; individual layers of the fluid management assembly 144 may be bonded or otherwise secured to one another without adversely affecting fluid management by thermal welding, see Paragraph [0056]) having a notch (relief area 278 may form or be a gap, a slot, a taper, or cut at the first and the second side 256, see Figure 7M; the fluid management assembly 144 may be a fluid management assembly 144m, see Paragraph [0059]), an aperture (opening 276), and a perimeter (perimeter around first end 252 and 254, see Figure 7M);
a cavity formed in the thermoformed layer (relief area 278 forms a slot, see Figure 7M), the cavity having a perimeter (see Figure 7M), the perimeter of the cavity being substantially parallel to the perimeter of the thermoformed layer (see Figure 7M);
a film layer (base layer 132, see Figure 4B) having a perimeter (periphery 152), wherein the perimeter of the film layer (152) is substantially parallel to the perimeter of the thermoformed layer (parallel to fluid management assembly 144, see Figure 4B), wherein the perimeter of the film layer (132) is coupled to the perimeter of the thermoformed layer (144) to define a sealed space (layers are sealed at the perimeters, see Figure 10B).
Regarding Claim 45, Rehbein further teaches wherein the sealed space is defined by the film layer and the cavity of the thermoformed layer (sealed space is formed between the film layer 132 and the fluid management assembly 144 to form fluid dispersion zones 268, see Figure 10B).
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Regarding Claim 47, Rehbein further teaches a second film layer (sealing member 140) having an inner perimeter (perimeter of notched area, see below) and an outer perimeter (periphery 164), the inner perimeter being substantially parallel to the perimeter of the thermoformed layer (see Figure 10B), the outer perimeter being substantially parallel to the perimeter of the thermoformed layer (parallel to the periphery 152 of the base layer 132, see Figure 4 and 10B), the second film layer being coupled to the thermoformed layer near the perimeter of the thermoformed layer (the periphery 164 of the sealing member 140 may be positioned proximate to the periphery 152 of the base layer 132, see Paragraph [0048]).
Regarding Claim 48, Rehbein teaches all of the limitations in claim 47 and further teaches wherein the inner perimeter bounds an area less than an area bound by the perimeter of the thermoformed layer (the inner perimeter has a smaller area than the entire periphery of layer 144, see above).
Regarding Claim 49, Rehbein teaches all of the limitations in claim 47 and further teaches wherein the outer perimeter bounds an area greater than an area bound by the perimeter of the thermoformed layer (in some embodiments, a portion of the periphery 164 of the sealing member 140 may extend beyond the periphery 152 of the base layer 132 and into direct contact with tissue surrounding the tissue site 104, see Paragraph [0048]).
Regarding Claim 50, Rehbein further teaches wherein an adhesive is disposed on a surface of the first film layer opposite the thermoformed layer (the adhesive 136 may be in fluid communication with the apertures 160 in at least the periphery 152 of the base layer 132, see Paragraph [0040]).
Claims 44-46 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sung (US 20140257242 A1).
Regarding Claim 44, Sung teaches an apparatus for distributing force across a tissue site (dressing 10, see Abstract; Figure 6a-b), comprising:
a thermoformed layer (base 20) having a notch (slit 50), an aperture (60), and a perimeter (frame 140 of pad 30, see Figure 6a);
a cavity formed in the thermoformed layer (opening 190), the cavity having a perimeter (inner perimeter of opening 190, see Figure 7c), the perimeter of the cavity being substantially parallel to the perimeter of the thermoformed layer (see Figure 7c);
a film layer having a perimeter (dressing film 40 with a perimeter, see Figure 6b), wherein the perimeter of the film layer is substantially parallel to the perimeter of the thermoformed layer (film 40 parallel to pad 30, see Figure 6a), wherein the perimeter of the film layer is coupled to the perimeter of the thermoformed layer to define a sealed space (the perimeter of film 40 bonded at a perimeter of pad 140 to form a sealed space, see Figure 6b).
Regarding Claim 45, Sung further teaches wherein the sealed space is defined by the film layer and the cavity of the thermoformed layer (see Figure 6b).
Regarding Claim 46, Sung further teaches a foam disposed in the sealed space (pad 30 may be a foam material, see Paragraph [0068]).
Regarding Claim 50, Sung further teaches wherein an adhesive (adhesive 80) is disposed on a surface of the first film layer opposite the thermoformed layer (disposed on the proximal surface of the dressing film 40, see Paragraph [0051]; Figure 6b).
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.
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.
Claims 46 is rejected under 35 U.S.C. 103 as being unpatentable over Rehbein (US 20220183895 A1) in view of Coulthard et al. (US 20100305490 A1), hereinafter referred to as “Coulthard”.
Regarding Claim 46, Rehbein teaches all of the limitations as discussed above. However, Rehbein does not explicitly disclose a foam disposed in the sealed space.
Coulthard teaches a reduced pressure dressing (104) comprising a first layer (240), a second layer (232), a foam (second manifold layer 236 may include a plurality of interconnected cells that form a porous foam, see Figure 3; Paragraph [0073]) disposed in the sealed space (disposed between layers 240 and 232, see Figure 3).
Rehbein and Coulthard are analogous art because both disclose a reduce pressure dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sealed space of Rehbein and further include a foam disposed in the sealed space, as taught by Coulthard. Coulthard teaches it is beneficial for the second foam manifold layer to distributes the reduced pressure more uniformly across the surface of the diverter layer (see Paragraph [0073]).
Claims 52, 54-56 and 58 is rejected under 35 U.S.C. 103 as being unpatentable over Rehbein (US 20220183895 A1) in view of Locke et al. (US 20190343687 A1), hereinafter referred to as “Locke”.
Regarding Claim 52, Rehbein teaches an apparatus for distributing forces across a tissue site (wound dressing 124 across tissue site 104, see Figure 1 and 10B), comprising:
a first thermoformed layer (fluid management assembly 144; individual layers of the fluid management assembly 144 may be bonded or otherwise secured to one another without adversely affecting fluid management by thermal welding, see Paragraph [0056]) having a planar region (see Figure 4B and 7M), a notch formed through the planar region, and an aperture formed through the planar region (relief area 278 may form or be a gap, a slot, a taper, or cut at the first and the second side 256, see Figure 7M; the fluid management assembly 144 may be a fluid management assembly 144m, see Paragraph [0059]); and
a film layer coupled to a surface of the first thermoformed layer opposite the second thermoformed layer (base layer 132 coupled to the surface of layer 144, see Figure 4B), the film layer having a perimeter (periphery 152) similar to the perimeter of the first thermoformed layer (see Figure 4B).
However, Rehbein does not explicitly disclose a plurality of standoffs formed on the planar region, each standoff defining a cavity in the first thermoformed layer; and a second thermoformed layer having a cavity formed in the second thermoformed layer, the second thermoformed layer coupled to the first thermoformed layer near a perimeter of the first thermoformed layer, the cavity of the second thermoformed layer enclosing the plurality of standoffs.
Locke teaches an apparatus for distributing forces across a tissue site (160, see Figures 3D, 10, and 11A) comprising a plurality of standoffs formed on the planar region (standoff 380), each standoff defining a cavity in the first thermoformed layer (cavity between the standoffs on spacer layer 1010, see Figure 10); a second thermoformed layer (spacer layer 1005) having a cavity formed in the second thermoformed layer (cavity formed by standoffs 380m see Figure 10), the second thermoformed layer coupled to the first thermoformed layer near a perimeter of the first thermoformed layer (a periphery of the first spacer layer 1005 may be coupled to a periphery of the second spacer layer 1010 to form the flange 325, see Figure 11A; Paragraph [0138]), the cavity of the second thermoformed layer enclosing the plurality of standoffs (the first spacer layer 1005 and the second spacer layer 1010 can be coupled to form a liquid barrier defining a fluid path along a longitudinal axis of the bridge 160.see Figure 11A; Paragraph [0138]).
Rehbein and Locke are analogous art because both discloses a negative pressure wound therapy device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the wound dressing layers of Rehbein and further include a plurality of standoffs formed on the first thermoformed layer and a second thermoformed layer coupled to the first thermoformed layer near a perimeter of the first thermoformed layer, as taught by Locke. Locke teaches the layers are beneficial to have a low-profile and/or be conformable, for improved comfort if positioned under a patient for example. Some embodiments may be configured to prevent occlusion, maintaining an open pathway for negative-pressure treatment so that the negative pressure may be provided even when the device is under compressive load (for example, if the patient is lying atop the device) (see Paragraph [0186]).
Regarding Claim 54, Rehbein and Locke teaches all of the limitations as discussed above in claim 52. However, Rehbein and Locke do not explicitly a second film layer having an inner perimeter and an outer perimeter, the inner perimeter being substantially parallel to a perimeter of the second thermoformed layer, the outer perimeter being substantially parallel to the inner perimeter, the second film layer being coupled to the second thermoformed layer near the perimeter of the second thermoformed layer.
Locke teaches a reduced pressure dressing (104) comprising: a second film layer (sealing member 315) having an inner perimeter (see below) and an outer perimeter (see below), the inner perimeter being substantially parallel to a perimeter of the second thermoformed layer (film layer 315 is parallel to the perimeter of second thermoformed layer 1005, see Figure 10), the outer perimeter being substantially parallel to the inner perimeter (see Figure 10), the second film layer (315) being coupled to the second thermoformed layer near the perimeter of the second thermoformed layer (the first layer 315 may be coupled to the first spacer layer 1005, see Figure 10 and 11A).
Locke and Coulthard are analogous art because both disclose a reduce pressure dressing.
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It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the apparatus of modified Rehbein and further include a second film layer having an inner perimeter and an outer perimeter, the inner perimeter being substantially parallel to a perimeter of the second thermoformed layer, the outer perimeter being substantially parallel to the inner perimeter, the second film layer being coupled to the second thermoformed layer near the perimeter of the second thermoformed layer, as taught by Coulthard. Coulthard teaches it is beneficial for the support layer to be configured within the envelope to maintain an open fluid pathway when under compression and/or to be foldable while still maintaining open fluid pathway (see Paragraph [0011]).
Regarding Claim 55, Modified Rehbein teaches all of the limitations as discussed above in claim 54 and Locke further teaches wherein the inner perimeter bounds an area less than an area bound by the perimeter of the second thermoformed layer (the inner perimeter of the notched area is smaller area than the perimeter of layer 1005, see above).
Regarding Claim 56, Modified Rehbein teaches all of the limitations as discussed above in claim 54 and Locke further teaches wherein the outer perimeter bounds an area greater than an area bound by the perimeter of the second thermoformed layer (the plurality of supports located on the first and second thermoformed layers may be located between the first layer and the second layer, see Figure 11A; Paragraph [0011]).
Regarding Claim 58, Modified Rehbein teaches all of the limitations as discussed above in claim 54 and Locke further teaches wherein an adhesive is disposed on a surface of the second film layer facing the second thermoformed layer (the first layer 315 and the spacer layer may be adhesively bonded to each other, see Paragraph [0109).
Claims 53 are rejected under 35 U.S.C. 103 as being unpatentable over Rehbein and Locke as applied to claim 52 above, and further in view of Coulthard (US 20100305490 A1).
Regarding Claim 53, Rehbein and Locke teaches all of the limitations as discussed above in claim 52. However, Rehbein and Locke do not explicitly disclose a foam disposed in the cavity of the second thermoformed layer between the first thermoformed layer and the second thermoformed layer.
Coulthard teaches a reduced pressure dressing (104) comprising a first layer (240), a second layer (232), a foam (second manifold layer 236 may include a plurality of interconnected cells that form a porous foam, see Figure 3; Paragraph [0073]) disposed in the cavity of the second thermoformed layer between the first thermoformed layer and the second thermoformed layer (disposed between layers 240 and 232, see Figure 3).
Rehbein, Locke, and Coulthard are analogous art because both disclose a reduce pressure dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sealed space of modified Rehbein and further include a foam disposed in the sealed space, as taught by Coulthard. Coulthard teaches it is beneficial for the second foam manifold layer to distributes the reduced pressure more uniformly across the surface of the diverter layer (see Paragraph [0073]).
Claims 47-49 is rejected under 35 U.S.C. 103 as being unpatentable over Sung (US 20140257242 A1) in view of Heinecke et al. (CN 111200999 A), hereinafter referred to as “Heinecke”.
Regarding Claim 47, Sung teaches all of limitation as discussed above in claim 44. However, Sung does not explicitly disclose a second film layer having an inner perimeter and an outer perimeter, the inner perimeter being substantially parallel to the perimeter of the thermoformed layer, the outer perimeter being substantially parallel to the perimeter of the thermoformed layer, the second film layer being coupled to the thermoformed layer near the perimeter of the thermoformed layer.
Heinecke teaches an apparatus for distributing force across a tissue site (medical dressing, see Figures 1-3) comprising a thermoformed layer (support material layer 130), a first film layer (backing layer 120), a second film layer (carrier layer 110) having an inner perimeter (inner perimeter accommodating groove 140, see Figure 2) and an outer perimeter (outer perimeter of carrier layer 110), the inner perimeter being substantially parallel to the perimeter of the thermoformed layer (see Figure 3), the outer perimeter being substantially parallel to the perimeter of the thermoformed layer (see Figure 3), and the second film layer being coupled to the thermoformed layer near the perimeter of the thermoformed layer (carrier layer 110 coupled near the perimeter of backing layer 120, see Figure 3).
Sung and Heinecke are analogous art because both teach a medical dressing having multiple layers.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the apparatus of Sung and further include a second film layer and the second film layer being coupled to the thermoformed layer near the perimeter of the thermoformed layer, as taught by Heinecke. Heinecke teaches the configuration allows for the medical dressing to have a flexible and conformable boundary when the attached to the skin and a device such as catheter, to facilitate the medical dressing firmly adhered and fixed to the skin in a long time (see Abstract).
Regarding Claim 48, Sung and Heinecke teaches all of the limitations as discussed above in claim 47 and Heinecke further teaches wherein the inner perimeter bounds an area less than an area bound by the perimeter of the thermoformed layer (groove 140 forms the inner perimeter of carrier layer 110 which has an area less than the perimeter of layer 120, see Figure 2).
Regarding Claim 49, Sung and Heinecke teaches all of the limitations as discussed above in claim 47 and Heinecke further teaches wherein the outer perimeter bounds an area greater than an area bound by the perimeter of the thermoformed layer (carrier layer 110 has an outer perimeter greater than the perimeter of layer 120, see Figure 3).
Claims 52, 54-56, and 58 is rejected under 35 U.S.C. 103 as being unpatentable over Sung (US 20140257242 A1) in view of Locke (US 20190343687 A1).
Regarding Claim 52, Sung teaches an apparatus for distributing forces across a tissue site (dressing 10, see Abstract; Figure 6a-b), comprising:
a first thermoformed layer (base 20) having a planar region (pad 30), a notch (slit 50) formed through the planar region (see Figure 7c), and an aperture formed through the planar region (aperture 60); and
a film layer coupled to a surface of the first thermoformed layer opposite the second thermoformed layer (dressing film 40 with a perimeter coupled to the distal surface of base layer 20, see Figure 6b), the film layer having a perimeter (perimeter of film layer 40see Figure 6a-b).
However, Sung does not explicitly disclose a plurality of standoffs formed on the planar region, each standoff defining a cavity in the first thermoformed layer; a second thermoformed layer having a cavity formed in the second thermoformed layer, the second thermoformed layer coupled to the first thermoformed layer near a perimeter of the first thermoformed layer, the cavity of the second thermoformed layer enclosing the plurality of standoffs.
Locke teaches an apparatus for distributing forces across a tissue site (160, see Figures 3D, 10, and 11A) comprising a plurality of standoffs formed on the planar region (standoff 380), each standoff defining a cavity in the first thermoformed layer (cavity between the standoffs on spacer layer 1010, see Figure 10); a second thermoformed layer (spacer layer 1005) having a cavity formed in the second thermoformed layer (cavity formed by standoffs 380m see Figure 10), the second thermoformed layer coupled to the first thermoformed layer near a perimeter of the first thermoformed layer (a periphery of the first spacer layer 1005 may be coupled to a periphery of the second spacer layer 1010 to form the flange 325, see Figure 11A; Paragraph [0138]), the cavity of the second thermoformed layer enclosing the plurality of standoffs (the first spacer layer 1005 and the second spacer layer 1010 can be coupled to form a liquid barrier defining a fluid path along a longitudinal axis of the bridge 160.see Figure 11A; Paragraph [0138]).
Sung and Locke are analogous art because both discloses a medical wound dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the wound dressing layers of Sung and further include a plurality of standoffs formed on the first thermoformed layer and a second thermoformed layer coupled to the first thermoformed layer near a perimeter of the first thermoformed layer, as taught by Locke. Locke teaches the layers are beneficial to have a low-profile and/or be conformable, for improved comfort if positioned under a patient for example. Some embodiments may be configured to prevent occlusion, maintaining an open pathway for negative-pressure treatment so that the negative pressure may be provided even when the device is under compressive load (for example, if the patient is lying atop the device) (see Paragraph [0186]).
Regarding Claim 54, Sung teaches all of the limitations as discussed above in claim 52. However, Sung does not explicitly disclose a second film layer having an inner perimeter and an outer perimeter, the inner perimeter being substantially parallel to a perimeter of the second thermoformed layer, the outer perimeter being substantially parallel to the inner perimeter, the second film layer being coupled to the second thermoformed layer near the perimeter of the second thermoformed layer.
Locke teaches an apparatus for distributing forces across a tissue site (160, see Figures 3D, 10, and 11A) comprising a second film layer (sealing member 315) having an inner perimeter (see above) and an outer perimeter (see above), the inner perimeter being substantially parallel to a perimeter of the second thermoformed layer (film layer 315 is parallel to the perimeter of second thermoformed layer 1005, see Figure 10), the outer perimeter being substantially parallel to the inner perimeter (see Figure 10), the second film layer (315) being coupled to the second thermoformed layer near the perimeter of the second thermoformed layer (the first layer 315 may be coupled to the first spacer layer 1005, see Figure 10 and 11A).
Sung and Locke are analogous art because both discloses a medical wound dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the wound dressing layers of Sung and further include a second film layer being coupled to the second thermoformed layer near the perimeter of the second thermoformed layer, as taught by Locke. Locke teaches the support layer may be configured within the envelope to maintain an open fluid pathway when under compression and/or to be foldable while still maintaining open fluid pathway (see Paragraph [0011]).
Regarding Claim 55, Sung and Locke teaches all of the limitations as discussed above in claim 54 and Locke further teaches wherein the inner perimeter bounds an area less than an area bound by the perimeter of the second thermoformed layer (the inner perimeter is a smaller area than the perimeter of layer 1005, see above).
Regarding Claim 56, Sung and Locke teaches all of the limitations as discussed above in claim 54 and Locke further teaches wherein the outer perimeter bounds an area greater than an area bound by the perimeter of the second thermoformed layer ( the plurality of supports located on the first and second thermoformed layers may be located between the first layer and the second layer, see Figure 11A; Paragraph [0011]).
Regarding Claim 58, Sung and Locke teaches all of the limitations as discussed above in claim 54 and Locke further teaches wherein an adhesive is disposed on a surface of the second film layer facing the second thermoformed layer (the first layer 315 and the second layer 320 may be coupled around the periphery of the bridge 160 to form the sealed space by adhesive bonding, such as acrylics or cured adhesives, see Paragraph [0102]; the first layer 315 having adhesive facing spacer layer 1005. see Figure 10).
Claims 53 is rejected under 35 U.S.C. 103 as being unpatentable over Sung and Locke, as applied in claim 52, and further in view of Coulthard (US 20100305490 A1).
Regarding Claim 53, Sung and Locke teaches all of the limitations as discussed above in claim 52. However, Sung and Locke do not explicitly disclosed a foam disposed in the cavity of the second thermoformed layer between the first thermoformed layer and the second thermoformed layer.
Coulthard teaches a reduced pressure dressing (104) comprising a first layer (240), a second layer (232), a foam (second manifold layer 236 may include a plurality of interconnected cells that form a porous foam, see Figure 3; Paragraph [0073]) disposed in the sealed space (disposed between layers 240 and 232, see Figure 3).
Sung, Locke, and Coulthard are analogous art because both disclose a medical wound dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sealed space of modified Sung and further include a foam disposed in the sealed space, as taught by Coulthard. Coulthard teaches it is beneficial for the second foam manifold layer to distributes the reduced pressure more uniformly across the surface of the diverter layer (see Paragraph [0073]).
Conclusion
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/ERIC RASSAVONG/ (2/24/2026)Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781