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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: attachment device in claims 13-15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 3-9, 22, 39, 57, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Todd et al (US 5437651).
Regarding Claim 1, Todd discloses a negative-pressure dressing (10, Fig. 1) for use on a tissue site (Col. 4 lines 18-35), comprising:
a manifold (foam pad 12, Fig. 1) having a first surface and a second surface (as seen in Fig. 1); and
a cover (backing plate 16, Fig. 1) configured to be disposed over the manifold (12, Fig. 1), wherein the cover (16, Fig. 1) comprises:
an interior surface configured so that at least a portion of the interior surface faces towards the second surface of the manifold (12, Fig. 1),
an exterior surface (as seen in Fig. 1),
a port (orifice 18, Fig. 1) configured for introduction of negative pressure through the cover (16, Fig. 1; Col. 5 lines 35-44), and
a plurality of fluid transport features (channels 24, Fig. 2) on at least a portion of the interior surface configured for capillary action (Col. 5 line 53 – Col. 6 line 33).
Regarding Claim 3, Todd discloses the manifold is elongate (Col. 4 lines 28-36); and the fluid transport features (24, Fig. 2) are oriented to extend longitudinally along an elongate length of the manifold (12, Fig. 2; Col. 5 lines 3-34).
Regarding Claim 4, Todd discloses the cover (16, Fig. 1) further comprises a plurality of sidewalls and a cap and the fluid transport features (24, Fig. 2) are located on the cap (Col. 4 line 57 – Col. 5 line 14; the cover can be folded before being placed in/on a wound such that it has four sidewalls and a cap, and the sidewalls and the cap will have channels 24).
Regarding Claim 5, Todd discloses the plurality of sidewalls of the cover comprise two longitudinal sidewalls and two end sidewalls; and the fluid transport features (24, Fig. 2) also are located on the longitudinal sidewalls (Col. 4 line 57 – Col. 5 line 14; the cover can be folded before being placed in/on a wound such that it has four sidewalls and a cap, and the sidewalls and the cap will have channels 24).
Regarding Claim 6, Todd discloses the fluid transport features (24, Fig. 2) are located on all of the sidewalls (Col. 4 line 57 – Col. 5 line 14; the cover can be folded before being placed in/on a wound such that it has four sidewalls and a cap, and the sidewalls and the cap will have channels 24).
Regarding Claim 7, Todd discloses the plurality of fluid transport features (24, Fig. 2) comprise a plurality of channels (24, Fig. 2); and the plurality of channels (24, Fig. 2) comprise a plurality of ridges (22, Fig. 2) and a plurality of grooves (spaces between each ridge, Fig. 2).
Regarding Claim 8, Todd discloses at least some of the grooves (spaces between each ridge, Fig. 2) have a width configured to provide fluid transport via capillary action, even when negative pressure in the dressing is insufficient to induce fluid transport (Col. 6 lines 16-33).
Regarding Claim 9, Todd discloses the channels (24, Fig. 2) are configured to provide two different mechanisms for fluid movement through the dressing independent of the manifold (Col. 6 lines 16-33; flow with suction and flow without suction).
Regarding Claim 22, Todd discloses the cover (16, Fig. 2) contacts the second surface of the manifold (12, Fig. 1).
Regarding Claim 39, Todd discloses the fluid transport features (24, Fig. 2) are substantially coextensive with the interior surface along a portion of the cover (16, Fig. 2) adjacent to the manifold (12, Fig. 1).
Regarding Claim 57, Todd discloses the cover (16, Fig. 1) comprises a bag-like configuration having an open end configured to receive the manifold (Col. 4 line 57 – Col. 5 line 14; since the cover is flexible, it can be considered having a bag-like configuration when folded around the manifold).
Regarding Claim 60, Todd discloses an elongate negative-pressure dressing (10, Fig. 1; Col. 4 line 28-36, Col. 5 line 3-34) for use on a tissue site (Col. 4 lines 18-35), comprising:
a manifold (foam pad 12, Fig. 1) having a first surface configured to face the tissue site and an opposite second surface (as seen in Fig. 1); and
a cover (backing plate 16, Fig. 1) configured to be disposed over the manifold (12, Fig. 1), wherein the cover (16, Fig. 1) comprises:
an interior surface configured so that at least a top cap portion of the interior surface faces towards the second surface of the manifold (12, Fig. 1), and
a plurality of micro-molded features (channels 24, Fig. 2) on at least a portion of the interior surface configured for longitudinal fluid transport along an elongate length of the dressing (Col. 4 lines 28-36, Col. 5 line 3 – Col. 6 line 33).
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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Todd et al (US 5437651) in view of Lockwood et al (US 6855135).
Regarding Claim 2, Todd further discloses the plurality of fluid transport features comprise a plurality of channels sized for capillary action (Col. 5 line 53 – Col. 6 line 33).
Todd is silent whether the channels have a width of approximately 5-3000 micron.
Lockwood teaches a negative pressure wound dressing, thus being in the same field of endeavor, with a cover (52, Fig. 34) comprising a plurality of channels (56, Fig. 34), wherein the channels have a width of approximately 5-3000 micron (Col. 9 lines 8-12; the channels have a width of 762 microns). This allows for effective fluid flow through the channels even when vacuum is not present.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the channels of Todd to have a width of approximately 5-3000 micron, as taught by Lockwood, to allow for effective fluid flow through the channels even when vacuum is not present (as motivated by Lockwood Col. 9 lines 8-12).
Claim(s) 10-12, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Todd et al (US 5437651) in view of Johnston et al (US 2010/0318072).
Regarding Claims 10, 11, and 24, Todd is silent whether the plurality of ridges comprise a first portion of taller ridges and a second portion of shorter ridges; the taller ridges have a height greater than the shorter ridges; and two or more of the shorter ridges are located between each pair of adjacent taller ridges, and wherein the taller ridges are configured to form flow channels for transportation of fluid under negative pressure; and the shorter ridges are configured to transport fluid by capillary action, wherein the shorter ridges have a height of approximately 5-350 micron and the taller ridges have a height of approximately 25-3000 micron, wherein the groove between adjacent shorter ridges is approximately 5-350 micron, and wherein a space between adjacent taller ridges has a width of approximately 25-3000 micron.
Johnston teaches a fluid control film usable in wound dressings, thus being in the same field of endeavor, where the film has a plurality of ridges that comprise a first portion of taller ridges (618’’, Fig. 6c) and a second portion of shorter ridges (633, Fig. 6c); the taller ridges (618’’, Fig. 6c) have a height greater than the shorter ridges (633, Fig. 6c), and two or more of the shorter ridges (633, Fig. 6c) are located between each pair of adjacent taller ridges (618’’, Fig. 6c; ¶ [0061-0063]), wherein the taller ridges (618’’, Fig. 6c) are configured to form flow channels for transportation of fluid under negative pressure; and the shorter ridges (633, Fig. 6c) are configured to transport fluid by capillary action (¶ [0047, 0061-0063]), wherein the shorter ridges (633, Fig. 6c) have a height of approximately 5-350 micron (¶ [0070]) and the taller ridges (618’’, Fig. 6c) have a height of approximately 25-3000 micron (¶ [0067]), wherein the groove between adjacent shorter ridges (633, Fig. 6c) is approximately 5-350 micron (¶ [0102]), and wherein a space between adjacent taller ridges has a width of approximately 25-3000 micron (¶ [0066]). This allows the film to spontaneously transport liquids along the film even when suction is not applied (¶ [0047]).
Therefore, it would have been obvious to modify the cover of Todd to have the plurality of ridges comprise a first portion of taller ridges and a second portion of shorter ridges; the taller ridges have a height greater than the shorter ridges; and two or more of the shorter ridges are located between each pair of adjacent taller ridges, wherein the taller ridges are configured to form flow channels for transportation of fluid under negative pressure; and the shorter ridges are configured to transport fluid by capillary action, wherein the shorter ridges have a height of approximately 5-350 micron and the taller ridges have a height of approximately 25-3000 micron, wherein the groove between adjacent shorter ridges is approximately 5-350 micron, and wherein a space between adjacent taller ridges has a width of approximately 25-3000 micron, as taught by Johnson, to allow the film to spontaneously transport liquids along the film even when suction is not applied (as motivated by Johnson ¶ [0047]).
Regarding Claim 12, Todd is silent whether the cover further comprises a hydrophilic coating on the interior surface.
Johnson teaches the film comprises a hydrophilic coating on the interior surface (¶ [0052]) to ensure sufficient capillary forces in the presence of bodily fluids (¶ [0052]).
Therefore, it would have been obvious to modify the interior surface of Todd to include a hydrophilic coating, as taught by Johnson, to ensure sufficient capillary forces in the presence of bodily fluids (as motivated by Johnson ¶ [0052]).
Regarding Claim 23, Todd is silent whether the cover is not directly attached to the second surface of the manifold
Johnson teaches the film comprises a hydrophilic coating on the interior surface (¶ [0052]) to ensure sufficient capillary forces in the presence of bodily fluids (¶ [0052]).
Therefore, it would have been obvious to modify the interior surface of Todd to include a hydrophilic coating, as taught by Johnson, to ensure sufficient capillary forces in the presence of bodily fluids (as motivated by Johnson ¶ [0052]). This would result in the cover not being directly attached to the second surface of the manifold, but instead being indirectly attached to the manifold via the coating.
Claim(s) 13-20, 29, 38, 40, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Todd et al (US 5437651) in view of Locke et al (US 2018/0353338).
Regarding Claims 13 and 14, Todd is silent regarding an attachment device configured to sealingly attach the cover to the tissue site, wherein the cover further comprises a flange, and the attachment device is configured to attach the flange to the tissue site.
Locke teaches a negative pressure wound dressing, thus being in the same field of endeavor, where the cover (116, Fig. 2) comprises an attachment device (240, Fig. 2; ¶ [0065]) configured to sealingly attach the cover (116, Fig. 2) to the tissue site (¶ [0056, 0065-0066]), wherein the cover further comprises a flange; and the attachment device (240, Fig. 2) is configured to attach the flange to the tissue site (¶ [0056, 0065-0066]; since the cover is capable of adhering to the patient’s skin via adhesive on the periphery of the cover, the peripheral adhesive would be on a portion of the dressing that can be considered a flange extending outwardly past the manifold/lower layers).
Therefore, it would have been obvious to modify the cover of Todd to include an attachment device configured to sealingly attach the cover to the tissue site, wherein the cover further comprises a flange, and the attachment device is configured to attach the flange to the tissue site, as taught by Locke, to allow the dressing to adhere to the patient’s skin (as motivated by Locke ¶ [0056, 0065-0066]).
Regarding Claim 15, Todd discloses a negative-pressure dressing (10, Fig. 1) for use on a tissue site (Col. 4 lines 18-35), comprising:
a manifold (foam pad 12, Fig. 1) having a first surface and a second surface (as seen in Fig. 1); and
a cover (backing plate 16, Fig. 1) configured to be disposed over the manifold (12, Fig. 1), wherein the cover (16, Fig. 1) comprises:
an interior surface configured so that at least a portion of the interior surface faces towards the second surface of the manifold (12, Fig. 1),
an exterior surface (as seen in Fig. 1),
a port (orifice 18, Fig. 1) configured for introduction of negative pressure through the cover (16, Fig. 1; Col. 5 lines 35-44), and
a plurality of exudate transport features (channels 24, Fig. 2) on at least a portion of the interior surface configured for capillary action (Col. 5 line 53 – Col. 6 line 33).
Todd is silent regarding an attachment device having a treatment aperture; where the first surface of the manifold is configured to be at least partially exposed to the tissue site through the treatment aperture, and wherein the cover is coupled to the attachment device.
Locke teaches a negative pressure wound dressing, thus being in the same field of endeavor, where the cover (116, Fig. 2) comprises an attachment device (240, Fig. 2; ¶ [0065]) configured to sealingly attach the cover (116, Fig. 2) to the tissue site (¶ [0056, 0065-0066]), wherein the cover further comprises a flange; and the attachment device (240, Fig. 2) is configured to attach the flange to the tissue site (¶ [0056, 0065-0066]; since the cover is capable of adhering to the patient’s skin via adhesive on the periphery of the cover, the peripheral adhesive would be on a portion of the dressing that can be considered a flange extending outwardly past the manifold/lower layers). This structure will have the attachment device having a treatment aperture, the first surface of the manifold to be at least partially exposed to the tissue site through the treatment aperture, and the cover coupled to the attachment device.
Therefore, it would have been obvious to modify the cover of Todd to include an attachment device configured to sealingly attach the cover to the tissue site, wherein the cover further comprises a flange, and the attachment device is configured to attach the flange to the tissue site, as taught by Locke, to allow the dressing to adhere to the patient’s skin (as motivated by Locke ¶ [0056, 0065-0066]). This structure will have the attachment device having a treatment aperture, the first surface of the manifold to be at least partially exposed to the tissue site through the treatment aperture, and the cover coupled to the attachment device.
Regarding Claim 16, Todd further discloses the plurality of exudate transport features (24, Fig. 2) comprise a plurality of channels (24, Fig. 2) sized for capillary action (Col. 5 line 53 – Col. 6 line 33).
Regarding Claim 17, Todd further discloses the manifold is elongate (Col. 4 lines 28-36); and the fluid transport features (24, Fig. 2) are oriented to extend longitudinally along an elongate length of the manifold (12, Fig. 2; Col. 5 lines 3-34).
Regarding Claim 18, Todd discloses a negative-pressure dressing (10, Fig. 1) for use on a tissue site (Col. 4 lines 18-35), comprising:
a manifold (foam pad 12, Fig. 1) having a first surface and a second surface (as seen in Fig. 1), and a thickness therebetween (as seen in Fig. 1); and
a substantially fluid-impermeable cover (backing plate 16, Fig. 1) configured to be disposed over the manifold (12, Fig. 1), wherein the cover (16, Fig. 1) comprises:
an interior surface configured so that at least a portion of the interior surface faces towards the second surface of the manifold (12, Fig. 1),
an exterior surface (as seen in Fig. 1),
a port (orifice 18, Fig. 1) configured for introduction of negative pressure through the cover (16, Fig. 1; Col. 5 lines 35-44), and
a plurality of liquid channeling features (channels 24, Fig. 2) on at least a portion of the interior surface configured for capillary action (Col. 5 line 53 – Col. 6 line 33).
Todd is silent regarding a fluid-control layer comprising a substantially fluid-impermeable polymer film with a plurality of fluid passages extending through the polymer film, wherein the first surface of the manifold is disposed adjacent to the fluid-control layer.
Locke teaches a negative pressure dressing with a fluid-control layer (210, Fig. 5) comprising a substantially fluid-impermeable polymer film with a plurality of fluid passages (220, Fig. 5) extending through the polymer film (¶ [0048, 0054]), wherein the first surface of the manifold (205, Fig. 5) is disposed adjacent to the fluid-control layer (210, Fig. 5). This layer controls the amount of fluid that is delivered to the manifold from the wound during treatment (¶ [0054]).
Therefore, it would have been obvious to modify the dressing of Todd to include a fluid-control layer comprising a substantially impermeable polymer film with a plurality of fluid passages extending through the polymer film, wherein the first surface of the manifold is disposed adjacent to the fluid-control layer, as taught by Locke, to control the amount of fluid that is delivered to the manifold from the wound during treatment (as motivated by Locke ¶ [0048, 0054]).
Regarding Claim 19, Todd is silent regarding a sealing layer disposed adjacent to the fluid control layer opposite the manifold, the sealing layer having a plurality of apertures at least partially aligned with the fluid passages of the fluid control layer.
Locke teaches a sealing layer (505, Fig. 5; ¶ [0075]) disposed adjacent to the fluid controller layer (210, Fig. 5) opposite the manifold (205, Fig. 5), the sealing layer (505, Fig. 5) having a plurality of apertures (520, Fig. 5) at least partially aligned with the fluid passages (220, Fig. 5) of the fluid control layer (210, Fig. 5). This allows the dressing to form a fluid seal with the tissue site (¶ [0075]).
Therefore, it would have been obvious to modify the dressing of Todd/Locke to include a sealing layer disposed adjacent to the fluid control layer opposite the manifold, the sealing layer having a plurality of apertures at least partially aligned with the fluid passages of the fluid control layer, as taught by Locke, to allow the dressing to form a fluid seal with the tissue site (as motivated by Locke ¶ [0075]).
Regarding Claim 20, Todd further discloses the plurality of liquid channeling features (24, Fig. 2) comprise a plurality of channels (24, Fig. 2) sized for capillary action (Col. 5 line 53 – Col. 6 line 33); the manifold is elongate (Col. 4 lines 28-36); and the fluid transport features (24, Fig. 2) are oriented to extend longitudinally (12, Fig. 2; Col. 5 lines 3-34).
Regarding Claim 29, Todd further discloses the cover comprises a flat base from which the ridges project (as seen in Figs. 1 and 2)
Todd is silent whether the flat base has a thickness of approximately 75 micron or less.
Locke teaches a wound dressing with a cover made of a film that has a thickness of 75 micron or less (¶ [0038]).
Therefore, it would have been obvious to modify the thickness of the base of the cover of Todd to have a thickness of approximately 75 micron or less, as taught by Locke, who indicates that cover films for wound dressings are typically in this thickness range.
Regarding Claim 38, Todd further discloses the fluid transport features (24, Fig. 2) are substantially coextensive with the interior surface of the cover (16, Fig. 2) except for the flange.
Regarding Claim 40, Todd is silent regarding an attachment device having a treatment aperture; where the first surface of the manifold is configured to be at least partially exposed to the tissue site through the treatment aperture, and wherein the cover is configured to be disposed over the manifold and coupled to the attachment device around the manifold.
Locke teaches a negative pressure wound dressing, thus being in the same field of endeavor, where the cover (116, Fig. 2) comprises an attachment device (240, Fig. 2; ¶ [0065]) configured to sealingly attach the cover (116, Fig. 2) to the tissue site (¶ [0056, 0065-0066]), wherein the cover further comprises a flange; and the attachment device (240, Fig. 2) is configured to attach the flange to the tissue site (¶ [0056, 0065-0066]; since the cover is capable of adhering to the patient’s skin via adhesive on the periphery of the cover, the peripheral adhesive would be on a portion of the dressing that can be considered a flange extending outwardly past the manifold/lower layers). This structure will have the attachment device having a treatment aperture, the first surface of the manifold to be at least partially exposed to the tissue site through the treatment aperture, and the cover configured to be disposed over the manifold and coupled to the attachment device around the manifold.
Therefore, it would have been obvious to modify the cover of Todd to include an attachment device configured to sealingly attach the cover to the tissue site, wherein the cover further comprises a flange, and the attachment device is configured to attach the flange to the tissue site, as taught by Locke, to allow the dressing to adhere to the patient’s skin (as motivated by Locke ¶ [0056, 0065-0066]). This structure will have the attachment device having a treatment aperture, the first surface of the manifold to be at least partially exposed to the tissue site through the treatment aperture, and the cover configured to be disposed over the manifold and coupled to the attachment device around the manifold.
Regarding Claim 42, Todd is silent regarding a fluid-control layer comprising a substantially fluid-impermeable polymer film with a plurality of fluid passages extending through the polymer film, wherein the first surface of the manifold is disposed adjacent to the fluid-control layer.
Locke teaches a negative pressure dressing with a fluid-control layer (210, Fig. 5) comprising a substantially fluid-impermeable polymer film with a plurality of fluid passages (220, Fig. 5) extending through the polymer film (¶ [0048, 0054]), wherein the first surface of the manifold (205, Fig. 5) is disposed adjacent to the fluid-control layer (210, Fig. 5). This layer controls the amount of fluid that is delivered to the manifold from the wound during treatment (¶ [0054]).
Therefore, it would have been obvious to modify the dressing of Todd to include a fluid-control layer comprising a substantially impermeable polymer film with a plurality of fluid passages extending through the polymer film, wherein the first surface of the manifold is disposed adjacent to the fluid-control layer, as taught by Locke, to control the amount of fluid that is delivered to the manifold from the wound during treatment (as motivated by Locke ¶ [0048, 0054]).
Regarding Claim 44, Todd is silent regarding a sealing layer disposed adjacent to the fluid control layer opposite the manifold, the sealing layer having a plurality of apertures at least partially aligned with the fluid passages of the fluid control layer.
Locke teaches a sealing layer (505, Fig. 5; ¶ [0075]) disposed adjacent to the fluid controller layer (210, Fig. 5) opposite the manifold (205, Fig. 5), the sealing layer (505, Fig. 5) having a plurality of apertures (520, Fig. 5) at least partially aligned with the fluid passages (220, Fig. 5) of the fluid control layer (210, Fig. 5). This allows the dressing to form a fluid seal with the tissue site (¶ [0075]).
Therefore, it would have been obvious to modify the dressing of Todd/Locke to include a sealing layer disposed adjacent to the fluid control layer opposite the manifold, the sealing layer having a plurality of apertures at least partially aligned with the fluid passages of the fluid control layer, as taught by Locke, to allow the dressing to form a fluid seal with the tissue site (as motivated by Locke ¶ [0075]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781