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 .
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.
Claims 19-26, 28, and 30-38 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans (WO 2016174048 A1) in view of Waite (US 20200170841 A1).
Regarding Claim 19, Gowan discloses an apparatus to provide negative pressure to a wound site (Fig. 6B; ¶[0043] wound dressing), comprising: a hydrophilic manifold (Fig 6B, absorbent layer 612) positioned around a hydrophobic manifold (612 is positioned around 620, Fig 6B) configured to transmit negative pressure to a wound site (pump 616 transmits negative pressure through 620, Fig 6B).
Gowans is silent whether the hydrophilic manifold configured to prevent fluid from the wound site from traveling to the hydrophobic manifold when negative pressure is applied and allow fluid travel from the wound site to the hydrophobic manifold when negative pressure is not being applied.
However, Waite teaches a negative pressure wound dressing (¶ [0005]), thus from the same field of endeavor, with a hydrophilic manifold (secondary layer 107 may be comprised of a porous absorbent hydrophilic foam such as polyvinyl alcohol ¶[0051]) configured to prevent fluid from the wound site from traveling to the hydrophobic manifold when negative pressure is applied and allow fluid travel from the wound site to the hydrophobic manifold when negative pressure is not being applied (the pores of secondary layer 107 are capable of collapsing when negative pressure is applied to the dressing, which would prevent fluid transmission. When negative pressure is not applied, the pores in secondary layer 107 would return to their original configuration and permit fluid transmission, similar to the process described in the PGPUB of the instant application [0105]). Hydrophilic foams are well known in the art to be used for absorbent layers (¶ [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the generic absorbent material of the hydrophilic ring of Gowans for the specific porous hydrophilic foam such as polyvinyl alcohol of Waite. Waite teaches that hydrophilic foams are well known in the art to be used as absorbent layers (¶ [0051] of Waite), and one of ordinary skill in the art would find it obvious to simply substitute a generic absorbent material for the specific, well known absorbent material utilized by Waite. The porous hydrophilic manifold of Gowans/Waite will be configured to prevent fluid from the wound site from traveling to the hydrophobic manifold when negative pressure is applied and allow fluid travel from the wound site to the hydrophobic manifold when negative pressure is not being applied due to the porosity of the layer.
Regarding Claim 20, Gowans/Waite further discloses a cover layer (Fig 6B, second cover layer 619).
Regarding Claim 21, Gowans/Waite further discloses that the cover layer comprises an aperture (Fig 6B, opening in layer 619 wherein second filter 621 is disposed).
Regarding Claim 22, Gowans further discloses negative pressure source (pump 616, Fig 6B).
The embodiment of Fig 6B of Gowans is silent regarding a fluidic connector configured to transmit negative pressure from a negative pressure source to the wound site.
However, an additional embodiment of Gowans seen in Fig 1 teaches a fluidic connector (port 2150, Fig 1) configured to transmit negative pressure from a negative pressure source (2800, Fig 1) to the wound site since utilizing an external pump would reduce costs because a pump would not be needed in each dressing.
Therefore, it would have been obvious to substitute the integral pump of Fig 6B for the fluidic connector configured to transmit negative pressure from an external negative pressure source to the wound site, as seen in Fig 1, since utilizing the fluidic connector and external pump of Gowans Fig 1 would reduce costs because an integral pump would not be needed in each dressing.
Regarding Claim 23, Gowans/Waite further discloses a transmission manifold (Fig 6B, Spacer layer 611) positioned around the hydrophilic manifold (¶[0045] spacer layer 611 may surround absorbent layer 612).
Regarding Claim 24, Gowans/Waite further discloses an absorbent manifold (¶[0009] apparatus may include a further absorbent layer between the first and second cover layer which would extend to the perimeter of the first absorbent layer) positioned around the hydrophilic manifold (6B, 612).
Regarding Claim 25, Gowans/Waite further discloses a transmission manifold (Fig 6B, Spacer layer 611) positioned around the hydrophilic manifold (¶[0045] spacer layer 611 may surround absorbent layer 612) and an absorbent manifold (¶[0009] apparatus may include a further absorbent layer between the first and second cover layer which would extend to the perimeter of the first absorbent layer) positioned around the hydrophilic manifold (6B, 612).
Regarding Claim 26, Gowans/Waite further discloses a wound contact layer (Fig 6B, 610) positioned beneath the hydrophobic manifold (Fig 6B, 620) and the hydrophilic manifold (Fig 6B, 612).
Regarding Claim 28, Gowans/Waite further discloses that the transmission manifold comprises a material having a three-dimensional structure (Fig 6B ¶[0036] Spacer layer 611 may be a three-dimensional fabric).
Regarding Claim 30 and 31, Gowans is silent whether the hydrophilic manifold comprises hydrophilic foam, wherein the hydrophilic manifold comprises polyvinyl alcohol.
However, Waite teaches a negative pressure wound dressing (¶ [0005]), thus from the same field of endeavor, wherein the hydrophilic manifold comprises hydrophilic foam, wherein the hydrophilic manifold comprises polyvinyl alcohol (secondary layer 107 may be comprised of a porous absorbent hydrophilic foam such as polyvinyl alcohol ¶[0051]). Hydrophilic foams are well known in the art to be used for absorbent layers (¶ [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the generic absorbent material of the hydrophilic manifold of Gowans for the specific hydrophilic foam such as polyvinyl alcohol of Waite. Waite teaches that hydrophilic foams are well known in the art to be used as absorbent layers (¶ [0051] of Waite), and one of ordinary skill in the art would find it obvious to simply substitute a generic absorbent material for the specific, well known absorbent material utilized by Waite.
Regarding Claim 32, Gowans discloses a method for providing negative pressure to a wound site (¶[0002]), comprising: positioning a wound dressing over a wound (Fig. 6B; ¶[0006][0043] wound dressing may be positioned in contact with a wound), the wound dressing comprising a hydrophilic manifold (Fig 6B, absorbent layer 612) positioned around a hydrophobic manifold (612 is positioned around 620, Fig 6B) and applying negative pressure to the wound site via the wound dressing (pump 616 transmits negative pressure through 620, Fig 6B).
Gowans is silent whether the hydrophilic manifold is configured such that fluid from the wound site travels to the hydrophobic manifold when negative pressure is applied but fluid travel from the wound site to the hydrophobic manifold is prevented when negative pressure is not being applied.
However, Waite teaches a negative pressure wound dressing (¶[0005]), thus from the same field of endeavor, with a hydrophilic manifold (secondary layer 107 may be comprised of a porous absorbent hydrophilic foam such as polyvinyl alcohol ¶[0051]) is configured such that fluid from the wound site travels to the hydrophobic manifold when negative pressure is applied but fluid travel from the wound site to the hydrophobic manifold is prevented when negative pressure is not being applied. (the pores of secondary layer 107 are capable of collapsing when negative pressure is applied to the dressing, which would prevent fluid transmission. When negative pressure is not applied, the pores in secondary layer 107 would return to their original configuration and permit fluid transmission, similar to the process described in the PGPUB of the instant application [0105]). Hydrophilic foams are well known in the art to be used for absorbent layers (¶ [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the generic absorbent material of the hydrophilic ring of Gowans for the specific porous hydrophilic foam such as polyvinyl alcohol of Waite. Waite teaches that hydrophilic foams are well known in the art to be used as absorbent layers (¶ [0051] of Waite), and one of ordinary skill in the art would find it obvious to simply substitute a generic absorbent material for the specific, well known absorbent material utilized by Waite. The porous hydrophilic manifold of Gowans/Waite will be configured to prevent fluid from the wound site from traveling to the hydrophobic manifold when negative pressure is applied and allow fluid travel from the wound site to the hydrophobic manifold when negative pressure is not being applied due to the porosity of the layer.
Regarding Claim 33, Gowans/Waite further discloses that the wound dressing comprises a cover layer (Fig 6B, second cover layer 619).
Regarding Claim 34, Gowans/Waite further discloses that the cover layer comprises an aperture (Fig 6B, opening in layer 619 wherein second filter 621 is disposed).
Regarding Claim 35, Gowans further discloses negative pressure source (pump 616, Fig 6B).
The embodiment of Fig 6B of Gowans is silent whether the wound dressing comprises a fluidic connector configured to transmit negative pressure from a negative pressure source to the wound site.
However, an additional embodiment of Gowans seen in Fig 1 teaches a fluidic connector (port 2150, Fig 1) configured to transmit negative pressure from a negative pressure source (2800, Fig 1) to the wound site since utilizing an external pump would reduce costs because a pump would not be needed in each dressing.
Therefore, it would have been obvious to substitute the integral pump of Fig 6B for the fluidic connector configured to transmit negative pressure from an external negative pressure source to the wound site, as seen in Fig 1, since utilizing the fluidic connector and external pump of Gowans Fig 1 would reduce costs because an integral pump would not be needed in each dressing.
Regarding Claim 36, Gowans/Waite further discloses that the wound dressing comprises a transmission manifold (Fig 6B, Spacer layer 611) positioned around the hydrophilic manifold (¶[0045] spacer layer 611 may surround absorbent layer 612).
Regarding Claim 37, Gowans/Waite further discloses that the wound dressing comprises an absorbent manifold (¶[0009] apparatus may include a further absorbent layer between the first and second cover layer which would extend to the perimeter of the first absorbent layer) positioned around the hydrophilic manifold (6B, 612).
Regarding Claim 38, Gowans/Waite further discloses a transmission manifold (Fig 6B, Spacer layer 611) positioned around the hydrophilic manifold (¶[0045] spacer layer 611 may surround absorbent layer 612) and an absorbent manifold (¶[0009] apparatus may include a further absorbent layer between the first and second cover layer which would extend to the perimeter of the first absorbent layer) positioned around the hydrophilic manifold (6B, 612).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans (WO 2016174048 A1) in view of Waite (US 20200170841 A1), and further in view of Locke (US 20200093646 A1).
Regarding Claim 27, Gowans/Waite is silent whether the wound contact layer is perforated.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein the wound contact layer (perforated film layer 112, Fig 3) is perforated, because perforations may increase flexibility of the wound dressing and increase the uptake of wound fluid exudate (¶[0042]).
Therefore, it would have been obvious to modify the apparatus of Gowans/Waite so that the wound contact layer is perforated, as taught by Locke because perforations may increase flexibility of the wound dressing and increase the uptake of wound fluid exudate (as motivated by Locke ¶[0042]).
Claims 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans (WO 2016174048 A1) in view of Waite (US 20200170841 A1), and further in view of Locke (US 20220184294 A1).
Regarding Claim 29, Gowans/Waite is silent whether the hydrophobic manifold comprises a hydrophobic foam.
However, Locke teaches a wound dressing, thus from the same field of endeavor, wherein the hydrophobic manifold (fluid buffer 126, Fig 7A ¶[0070] comprises a hydrophobic foam (¶[0070]) because the use of a hydrophobic foam as a porous hydrophobic layer to limit the flow of fluid is well known in the art.
Therefore, it would have been obvious to simply substitute the hydrophobic manifold of Gowans with the porous hydrophobic foam, as taught by Locke, because the use of a hydrophobic foam as a porous hydrophobic layer to limit the flow of fluid is well known in the art, and would produce predictable results.
Conclusion
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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