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 .
Response to Arguments
Applicant’s amendment filed 04/07/2026 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 14, and 43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1-3, 5, 9, 10, 13, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Gardiner et al (US 2020/0129338) in view of Girardot et al (US 6325565) further in view of Shuler et al (US 2017/0028113).
Regarding Claim 1, Gardiner discloses a manifold pad (70, Fig. 3), comprising:
open-cell foam (¶ [0037-0039, 0140]); and
at least one channel (71, Fig. 3) extending through the open-cell foam (¶ [0037-0039, 0140]);
the at least one channel (71, Fig. 3) comprises a plurality of channels (71, Fig. 3)
Gardiner does not specifically teach that the channel is a skinned channel, the skin integrally formed on a portion of the foam interfacing with the channel, however, Gardiner teaches that the channel can be formed by punching with heated pins (¶ [0060]). Gardiner is also silent wherein the plurality of skinned channels include at least one vertical skinned channel and at least one horizontal skinned channel.
Girardot teaches a porous applicator device, thus being in the same field of endeavor of fluid transporting devices, where an impermeable coating can be formed on reservoirs within a porous/open-cell foam by thermally melting the porous material during formation of the reservoirs to form a skin (Col. 8 lines 43-47). This forms a skin that is integral with the foam.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the heated pin punching process of Gardiner to form an impermeable skin on the walls of the channels, where the skin is integrally formed on a portion of the foam interfacing with the channel, as taught by Girardot. Since Gardiner utilizes the channel to improve fluid distribution into the upper layer of the foam (¶ [0047]), one of ordinary skill in the art would have been motivated to utilize an impermeable skin such as that taught by Girardot on the walls of the channels to ensure that any fluid that enters the channels moves the entire length of the channels and is deposited in the upper layer of the foam, rather than prematurely spreading out of the channels into the lower layer of the foam.
Gardiner/Girardot is silent wherein the plurality of skinned channels includes at least one vertical skinned channel and at least one horizontal skinned channel.
Shuler teaches a wound dressing, thus being in the same field of endeavor, with a plurality of channels (175, Fig. 3C), where the plurality of channels includes at least one vertical channel (as seen in Fig. 3C) and at least one horizontal channel (as seen in Fig. 3C) to better distribute suction throughout the wound dressing (¶ [0050]).
Therefore, it would have been obvious to modify the dressing of Gardiner/Girardot to have the plurality of skinned channels include at least one vertical skinned channel and at least one horizontal skinned channel, as taught by Shuler, to allow for a more distributed suction profile throughout the dressing (as motivated by Shuler ¶ [0050]).
Regarding Claims 2 and 3, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses the at least one skinned channel comprises a skin that is substantially impermeable to liquid / a skin that is less permeable to liquid than the open-cell foam (Girardot Col. 8 lines 43-47).
Regarding Claim 5, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 4.
The combination of Gardiner/Girardot/Shuler further discloses the at least one skinned channel is configured to allow transport of fluid through the manifold pad without allowing the fluid to substantially exit the skinned channel and enter the open-cell foam through the skin (Girardot Col. 8 lines 43-47).
Regarding Claim 9, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses a first surface (top surface of Gardiner Fig. 3); a second surface (Gardiner 35, Fig. 3); and a thickness of the open-cell foam between the first surface (top surface of Gardiner Fig. 3) and the second surface (Gardiner 35, Fig. 3), wherein the at least one skinned channel (Gardiner 71, Fig. 3) extends between the first surface (top surface of Gardiner Fig. 3) and the second surface (Gardiner 35, Fig. 3).
Regarding Claim 10, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses a first surface (top surface of Gardiner Fig. 3); a second surface (Gardiner 35, Fig. 3); and perimeter side walls extending substantially parallel to the thickness (Gardiner Fig. 3), wherein the at least one skinned channel (Gardiner 71, Fig. 3) extends between perimeter sidewalls (Gardiner Fig. 3).
Regarding Claim 13, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses the at least one skinned channel (Gardiner 71, Fig. 3) forms a first fluid pathway through the manifold pad (Gardiner 70, Fig. 3), and a porous open-cell structure of the open-cell foam (Gardiner ¶ [0037-0039, 0140]) forms a second fluid pathway through the manifold pad (Gardiner 70, Fig. 3) that is fluidly isolated from the first fluid pathway through the manifold pad (Girardot Col. 8 lines 43-47).
Regarding Claim 22, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses the skin comprises a substrate material of the open-cell foam which is substantially impermeable to liquid or less permeable to liquid than the open-cell foam (Girardot Col. 8 lines 43-47).
Regarding Claim 23, Gardiner further discloses a first surface (top of foam 70, Fig. 3) configured to face away from the tissue site (¶ [0140]) towards a sealing member (21, Fig. 2e) of a dressing (60, Fig. 2e), a second surface (35, Fig. 3) configured to contact a treatment device (perforated layer 46, Fig. 2e) of the dressing (60, Fig. 2e), and a thickness of the open-cell foam between the first surface (top of foam 70, Fig. 3) and the second surface (35, Fig. 3).
Regarding Claim 24, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses the at least one skinned channel extending between the first surface and the second surface comprises an opening in the first surface configured to fluid communication with an instillation source (any openings on the first surface of Gardiner/Girardot/Shuler are fully capable of being in fluid communication with an instillation source).
Regarding Claim 25, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 1.
The combination of Gardiner/Girardot/Shuler further discloses the at least one vertical skinned channel is in fluid communication with at least one horizontal skinned channel (Shuler Fig. 3C).
Regarding Claim 26, the combination of Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 3.
The combination of Gardiner/Girardot/Shuler further discloses the skin extends along an entire perimeter length of each of the at least one skinned channel (Girardot Col. 8 lines 43-47).
Claim(s) 7, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gardiner et al (US 2020/0129338) in view of Girardot et al (US 6325565) further in view of Shuler et al (US 2017/0028113) further in view of Locke et al (US 2019/0343687).
Regarding Claims 7, 8, and 12, Gardiner/Girardot/Shuler is silent whether the open-cell foam is felted foam, and the at least one skinned channel is integrally formed during formation of the felted foam, wherein the felted foam comprises a firmness factor greater than 1 and no more than approximately 5, and wherein the felted foam has a compression axis substantially perpendicular to the at least one skinned channel.
Locke teaches a wound dressing, thus being in the same field of endeavor, with a manifold made of a felted foam that is made by heating and compressing a foam (¶ [0175]), where the felted foam has a firmness factor of greater than 1 and no more than approximately 5 (¶ [0175]). This alters the compressibility and collapse of the dressing during wound treatment (¶ [0175]).
Therefore, it would have been obvious to modify the foam of Gardiner/Girardot/Shuler to be felted foam comprising a firmness factor of greater than 1 and no more than approximately 5, as taught by Locke (¶ [0175]) to alter the compressibility and collapse of the dressing during wound treatment (as motivated by Locke ¶ [0175]). The combination of Gardiner/Girardot/Shuler/Locke would have the skinned channels formed integrally during formation of the felted foam as this would simplify manufacturing by performing two steps that require heating at the same time, and since the foam of Locke can be felted in any direction, it is within the realm of one of ordinary skill in the art to have the felted foam of Gardiner/Girardot/Shuler/Locke to have a compression axis substantially perpendicular to the at least one skinned channel.
Claim(s) 14-16, 33, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Stevenson et al (US 2010/0069885) in view of Gardiner et al (US 2020/0129338) further in view of Girardot et al (US 6325565) further in view of Shuler et al (US 2017/0028113).
Regarding Claim 14, Stevenson discloses a dressing for treating a tissue site, comprising:
a treatment device (102, Fig. 1A/B) configured to channel fluid radially under applied negative pressure or instillation (¶ [0026-0029]), wherein the treatment device (102, Figs. 1A/B) comprises a film layer (first and second encapsulating members 168 and 170, Figs. 1A/B; ¶ [0047]) and a treatment manifold (160, Fig. 1A/B) encapsulated within the film layer (first and second encapsulating members 168 and 170, Figs. 1A/B; ¶ [0047]); and
an open-cell foam (¶ [0031]) manifold pad (122, Fig. 1A).
Stevenson is silent whether the manifold pad comprises at least one skinned channel through the open-cell foam, wherein the at least one skinned channel comprises a skin that is substantially impermeable to liquid, wherein the at least one skinned channel comprises a plurality of skinned channels, and wherein the plurality of skinned channels include at least one vertical skinned channel and at least one horizontal skinned channel.
As set forth above for Claim 1, Gardiner/Gerardot/Shuler discloses a manifold pad comprising at least one skinned channel through the open-cell foam, wherein the at least one skinned channel comprises a skin that is substantially impermeable to liquid, wherein the at least one skinned channel comprises a plurality of skinned channels, and wherein the plurality of skinned channels include at least one vertical skinned channel and at least one horizontal skinned channel. Since Stevenson indicates that the open-cell foam manifold can include a plurality of flow channels or pathways to improve the distribution of fluid throughout the manifold (Stevenson ¶ [0031]), one of ordinary skill in the art would have found it obvious to modify the open-cell foam manifold of Stevenson to comprise the at least one skinned channel through the open-cell foam, wherein the at least one skinned channel comprises a skin that is substantially impermeable to liquid, wherein the at least one skinned channel comprises a plurality of skinned channels, and wherein the plurality of skinned channels include at least one vertical skinned channel and at least one horizontal skinned channel of Gardiner/Gerardot/Shuler, to provide specific impermeable channels through the manifold of Stevenson to improve the distribution of fluids through the manifold of Stevenson/Gardiner/Gerardot/Shuler.
Regarding Claims 15, 16, and 42, the combination of Stevenson/Gardiner/Girardot/Shuler discloses the claimed subject matter substantially as claimed as set forth above for Claim 14.
The combination of Stevenson/Gardiner/Girardot/Shuler further discloses the at least one skinned channel (Gardiner 71, Fig. 3) forms a first fluid pathway, and the porous open-cell structure of the open-cell foam (Gardiner ¶ [0037-0039, 0140]) forms a second fluid pathway through the manifold pad (Gardiner 70, Fig. 3) that is fluidly isolated from the first fluid pathway through the manifold pad (Girardot Col. 8 lines 43-47).
Regarding Claim 33, Stevenson further discloses a sealing member (124, Fig. 1A) configured to sealingly cover the manifold pad (122, Fig. 1A) and the treatment device (102, Fig. 1A), wherein the treatment device (102, Fig. 1A) is configured to be disposed between the tissue site (104, Fig. 1A) and the manifold pad (122, Fig. 1A), and the manifold pad (122, Fig. 1A) is configured to be disposed between the treatment device (102, Fig. 1A) and the sealing member (124, Fig. 1A).
Claim(s) 43, 44, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Stevenson et al (US 2010/0069885) in view of Gardiner et al (US 2020/0129338) further in view of Girardot et al (US 6325565) further in view of Robinson et al (US 2014/0276489).
Regarding Claim 43, Stevenson discloses a system (100, Fig. 1A) for providing negative-pressure therapy and instillation to a tissue site, comprising:
a treatment device (102, Fig. 1A/B) including a film layer (first and second encapsulating members 168 and 170, Figs. 1A/B; ¶ [0047]) and a treatment manifold (160, Fig. 1A/B) encapsulated within the film layer (first and second encapsulating members 168 and 170, Figs. 1A/B; ¶ [0047]), the treatment device (102, Fig. 1A/B) configured to channel fluid radially under applied negative pressure or instillation (¶ [0026-0029]);
an open-cell foam (¶ [0031]) manifold pad (122, Fig. 1A) including a first surface (top surface, Fig. 1A), a second surface (bottom surface, Fig. 1A) opposite the first surface (top surface, Fig. 1A), and a thickness extending between the first surface (top surface, Fig. 1A) and the second surface (bottom surface, Fig. 1A);
a sealing member (124, Fig. 1A) configured to cover the manifold pad (122, Fig. 1A) and the treatment device (102, Fig. 1A), wherein the sealing member (124, Fig. 1A) contacts the first surface (top surface, Fig. 1A) of the manifold pad (122, Fig. 1A);
a negative-pressure source (132, Fig. 1A) configured to be in fluid communication with the open-cell foam of the manifold pad (122, Fig. 1A) through the sealing member (124, Fig. 1A; ¶ [0029]).
Stevenson is silent whether the manifold pad comprises at least one skinned channel through the first surface, the second surface, and the thickness of the open cell foam, wherein the at least one skinned channel comprises a skin that is substantially impermeable to liquid, and silent regarding an instillation solution source configured to be in fluid communication with the at least one skinned channel of the manifold pad through the sealing member.
Gardiner teaches an open-cell foam (¶ [0037-0039, 0140]) manifold pad (foam layer 2, Fig. 3) including a first surface (top surface of 2, Fig. 3), a second surface (bottom surface of 2, Fig. 3) opposite the first surface (top surface of 2, Fig. 3), and a thickness extending between the first surface (top surface of 2, Fig. 3) and the second surface (bottom surface of 2, Fig. 3), the manifold comprising at least one channel (71, Fig. 3) through the first surface (top surface of 2, Fig. 3), the second surface (bottom surface of 3, Fig. 3) and the thickness of the open-cell foam (¶ [0037-0039, 0140]). The channels facilitate fluid transport between the first and second surface of the foam layer (¶ [0142]).
Therefore, it would have been obvious to modify the manifold pad of Stevenson to include at least one channel through the first surface, the second surface, and the thickness of the open cell foam, as taught by Gardiner, to facilitate transport between the first and second surface of the foam layer (as motivated by Gardiner ¶ [0142]).
Stevenson/Gardiner does not specifically teach that the channel is a skinned channel comprising a skin that is substantially impermeable to liquid, however, Gardiner teaches that the channel can be formed by punching with heated pins (¶ [0060]).
Girardot teaches a porous applicator device, thus being in the same field of endeavor of fluid transporting devices, where an impermeable coating can be formed on reservoirs within a porous/open-cell foam by thermally melting the porous material during formation of the reservoirs to form a skin (Col. 8 lines 43-47).
Therefore, it would have been obvious to utilize the heated pin punching process of Girardot on the device of Stevenson/Gardiner to form an impermeable skin on the walls of the channels, as taught by Girardot. Since Gardiner utilizes the channel to improve fluid distribution into the upper layer of the foam (¶ [0047]), one of ordinary skill in the art would have been motivated to utilize an impermeable skin such as that taught by Girardot on the walls of the channels to ensure that any fluid that enters the channels moves the entire length of the channels and is deposited in the upper layer of the foam, rather than prematurely spreading out of the channels into the lower layer of the foam.
Stevenson/Gardiner/Girardot is silent regarding an instillation solution source configured to be in fluid communication with the at least one skinned channel of the manifold pad through the sealing member.
Robinson teaches a wound dressing, thus being in the same field of endeavor, with an instillation solution source (190, Fig. 1) included within the therapy device (124, Fig. 1) along with a reduced-pressure source (188, Fig. 1). This allows the therapy device to deliver both negative pressure and instillation fluid therapy to the wound dressing, improving the healing of the wound (¶ [0032]).
Therefore, it would have been obvious to modify the device of Stevenson/Gardiner/Girardot to include an instillation solution source configured to be in fluid communication with the at least one skinned channel of the manifold pad through the sealing layer, as taught by Robinson, to allow the system to deliver both negative pressure and instillation fluid therapy to the wound dressing, thereby improving the healing of the wound (as motivated by Robinson ¶ [0032]).
Regarding Claim 44, Stevenson further discloses the treatment device (102, Fig. 1A) is configured to be disposed between the tissue site (104, Fig. 1A) and the manifold pad (122, Fig. 1A), and the manifold pad (122, Fig. 1A) is configured to be disposed between the treatment device (102, Fig. 1A) and the sealing member (124, Fig. 1A), and wherein the second surface (bottom surface of 122, Fig. 1A) of the manifold pad (122, Fig. 1A) is configured to contact the film layer (168/170, Fig. 1A/B) of the treatment device (102, Fig. 1A).
Regarding Claim 46, the combination of Stevenson/Gardiner/Girardot/Robinson discloses the claimed subject matter substantially as claimed as set forth above for Claim 43.
The combination of Stevenson/Gardiner/Girardot/Robinson further discloses both the at least one skinned channel and the open-cell foam are configured to be in fluid communication with the treatment device, as both the foam and the skinned channels provide fluid pathways through the manifold pad of Stevenson/Gardiner/Girardot/Robinson.
Regarding Claim 48, the combination of Stevenson/Gardiner/Girardot/Robinson discloses the claimed subject matter substantially as claimed as set forth above for Claim 43.
The combination of Stevenson/Gardiner/Girardot/Robinson further discloses the skin is configured to fluidly isolate the at least one skinned channel from the open-cell foam through the manifold pad, as the skinned channel is impermeable to fluid and therefore will isolate the skinned channel from the open-cell foam through the manifold pad.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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