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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered.
Response to Arguments
Applicant’s amendments filed 11/25/2025 have been accepted and entered.
Applicant’s arguments with respect to claim(s) 1 and 24 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. A new Riesinger reference is now being cited to disclose the newly amended limitations, as set forth below.
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, 5-12, 15-17, 20, 24, 27, 30, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al (US 2015/0216733) in view of Riesinger (US 2012/0095419).
Regarding Claim 1, Allen discloses a system for treating a tissue site (¶ [0185]), comprising:
a dressing (300/2100/720/3400, Figs. 4A, 15B, 17, and 34A; ¶ [0185] indicates Fig. 34A shows the generic exploded view of a dressing, the layers can be shaped like the dressings shown in Figs 4A, 15B, and 17), comprising:
a base layer (wound contact layer 3460, Fig. 34A) including a periphery surrounding a central portion (as seen in Fig. 34A),
a sealing member (backing layer 3410, Fig. 34A) including a periphery and a central portion (as seen in Fig. 34A), the periphery of the sealing member (3410, Fig. 34A) positioned proximate to the periphery of the base layer (3460, Fig. 34A), wherein the central portion of the sealing member (3410, Fig. 34A) and the central portion of the base layer (3410, Fig. 34A) define an enclosure (¶ [0185, 0209]), and
a fluid management assembly (combination of absorbent layer 3430, wicking layer 3440, and transmission layer 3450, Fig. 34A) disposed in the enclosure (as seen in Fig. 34A) and including an articulation zone and a fluid dispersion zone (see Images 1-3), and wherein the fluid dispersion zone is configured to offload fluid away from the articulation zone (as seen in Images 1-3, the fluid dispersion zones are larger than the articulation zones and therefore are configured to absorb more fluid than the articulation zones, which would act to offload fluid away from the articulation zone),
the fluid management assembly (combination of absorbent layer 3430, wicking layer 3440, and transmission layer 3450, Fig. 34A) comprises an absorbent material (3430, Fig. 34A), a first wicking layer (3440, Fig. 34A), and a second wicking layer (transmission layer 3450, Fig. 34A); and
a reduced-pressure source configured to be coupled in fluid communication with the enclosure (¶ [0185, 0212]).
Allen is silent whether the articulation zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and whether the absorbent material is positioned in fluid communication between the first wicking layer and the second wicking layer, wherein the first wicking layer is coupled to the second wicking layer by a bond surrounding the absorbent material and the opening at the articulation zone, and wherein the absorbent material surrounds the opening.
Riesinger teaches a wound care article, thus being in the same field of endeavor, with an articulation zone including an opening (slit 19, Fig. 12) configured to be positioned at an articulation area at the tissue site (¶ [0086]), and an absorbent material (body 1, Fig. 1) positioned in fluid communication between a first wicking layer and a second wicking layer (shell 2, Fig. 1; ¶ [0022-0030, 0041-0048, 0063, 0124] indicates the shell can be made of various materials such as an airlaid cotton mat, and one of ordinary skill in the art would find it obvious that these materials would provide at least some directional wicking), wherein the first wicking layer and the second wicking layer (2, Fig. 1) are coupled together by a bond (seam 18, Fig. 12) surrounding the absorbent material (1, Figs. 1 and 12) and the opening (19, Fig. 12), and wherein the absorbent material (1, Figs. 1 and 12) surrounds the opening (19, Fig. 12). The shell allows the absorbent to swell as needed, and prevents exudate from flowing back into the wound while still allowing the improved conformability of the dressing due to the slit and seam of the shell (¶ [0022-0030, 0041-0048, 0063, 0086, 0124]).
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 fluid management assembly of Allen with the teachings of Riesinger to have the articulation zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and to have the absorbent material positioned in fluid communication between the first wicking layer and the second wicking layer, wherein the first and second wicking layers are couple together by a bond surrounding the absorbent material and the opening at the articulation zone, and wherein the absorbent material surrounds the opening, as taught by Riesinger. This structure of fluid management assembly allows the absorbent to swell as needed, and prevents exudate from flowing back into the wound while still allowing the improved conformability of the dressing due to the slit and seam of the shell (¶ [0022-0030, 0041-0048, 0063, 0086, 0124]).
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Image 1: Annotated Fig. 4A of Allen
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Image 2: Annotated Fig. 15B of Allen
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Image 3: Annotated Fig. 17 of Allen
Regarding Claim 5, Allen further discloses the articulation zone and the fluid dispersion zone are coplanar and configured to be positioned substantially parallel to a treatment surface at the tissue site (as seen in Images 1-3; when placed on the wound, the absorbent material will be substantially parallel to the treatment surface of the tissue site).
Regarding Claim 6, Allen further discloses the fluid dispersion zone comprises a plurality of fluid dispersion zones, wherein at least one of the fluid dispersion zones is positioned at each opposing end of the fluid management assembly, and wherein the articulation zone is positioned between the fluid dispersion zones (see in Image 1).
Regarding Claim 7, Allen further discloses the articulation zone is positioned at a first end of the fluid management assembly and the fluid dispersion zone is positioned at an opposing second end of the fluid management assembly (see Image 3).
Regarding Claim 8, Allen further discloses the fluid dispersion zone is configured to absorb more fluid than the articulation zone (as seen in Images 1-3, the fluid dispersion zones are larger than the articulation zones and therefore are configured to absorb more fluid than the articulation zones).
Regarding Claim 9, Allen further discloses the articulation zone includes a first absorbent capacity that is less than a second absorbent capacity of the fluid dispersion zone (as seen in Images 1-3, the fluid dispersion zones are larger than the articulation zones and therefore have a larger absorbent capacity than the articulation zones).
Regarding Claim 10, Allen further discloses the articulation zone is free of absorbent (see Image 2; ¶ [0152] indicates the slits increase the conformability of the dressing, and the specific area of the slits will be free of absorbent especially when the dressing flexes and the edges of the slits separate).
Regarding Claim 11, the combination of Allen/Riesinger discloses the claimed invention substantially as claimed as set forth above for Claim 10. The combination of Allen/Riesinger teaches the opening is disposed through the fluid management assembly (see Fig. 12 of Riesinger).
Regarding Claim 12, Allen further discloses least one relief area (see Image 1) positioned on opposing sides of the articulation zone (see Image 1).
Regarding Claim 15, Allen further discloses the fluid management assembly comprises a first axis (central longitudinal axis of Images 1-3) that is perpendicular to a second axis, wherein the first axis and the second axis each extend along the articulation zone and intersect at the articulation zone (the second axis can be any line perpendicular to the central longitudinal axis that extends through the articulation zone of Images 1-3), wherein the fluid dispersion zone is positioned outbound and coplanar to the articulation zone (see Images 1-3), and wherein the fluid dispersion zone is configured to absorb more fluid than the articulation zone (as seen in Images 1-3, the fluid dispersion zones are larger than the articulation zones and therefore are configured to absorb more fluid than the articulation zones).
Regarding Claim 16, Allen further discloses the fluid management assembly has a substantially symmetrical shape across at least one of the first axis and the second axis (see Images 1-3; all are substantially symmetrical across the central longitudinal axis/first axis).
Regarding Claim 17, Allen further discloses the articulation zone is in fluid communication with the fluid dispersion zone from a first end of the fluid management assembly to an opposing second end of the fluid management assembly (see Image 1).
Regarding Claim 20, Allen further discloses the base layer (3460, Fig. 34A) includes a plurality of apertures (perforations, ¶ [0186], visible in Fig. 34A) disposed through the periphery and the central portion (as seen in Fig. 34A), the system further comprising an adhesive disposed on a surface of at least a periphery of the sealing member (3410, Fig. 34A; ¶ [0209]) and configured to extend through the apertures at least in the periphery of the base layer (3410, Fig. 34A) to contact tissue surrounding the tissue site (¶ [0209]).
Regarding Claim 24, Allen discloses a dressing (300/2100/720/3400, Figs. 4A, 15B, 17, and 34A; ¶ [0185] indicates Fig. 34A shows the generic exploded view of a dressing, the layers can be shaped like the dressings shown in Figs 4A, 15B, and 17) for treating a tissue site (¶ [0185]), comprising:
a base layer (wound contact layer 3460, Fig. 34A) configured to be positioned at the tissue site (¶ [0186]);
a sealing member (backing layer 3410, Fig. 34A) configured to cover the base layer (3460, Fig. 34A) and to form a fluid seal relative to the tissue site (¶ [0209]); and
a fluid management assembly (combination of absorbent layer 3430, wicking layer 3440, and transmission layer 3450, Fig. 34A) positioned between the base layer (3460, Fig. 34A) and the sealing member (3410, Fig. 34A) and including a first zone and a second zone (see Images 1-3), and wherein the second zone is configured to offload fluid away from the first zone and the articulation zone (as seen in Images 1-3, the second zones are larger than the first zones and therefore are configured to absorb more fluid than the first zones, which would act to offload fluid away from the first zone),
the fluid management assembly (combination of absorbent layer 3430, wicking layer 3440, and transmission layer 3450, Fig. 34A) comprises an absorbent material (3430, Fig. 34A), a first wicking layer (3440, Fig. 34A), and a second wicking layer (transmission layer 3450, Fig. 34A).
Allen is silent whether the articulation zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and whether the absorbent material is surrounded by the at least one wicking layer, and the absorbent material surrounds the opening.
Riesinger teaches a wound care article, thus being in the same field of endeavor, with an articulation zone including an opening (slit 19, Fig. 12) configured to be positioned at an articulation area at the tissue site (¶ [0086]), and an absorbent material (body 1, Fig. 1) positioned in fluid communication between a first wicking layer and a second wicking layer (shell 2, Fig. 1; ¶ [0022-0030, 0041-0048, 0063, 0124] indicates the shell can be made of various materials such as an airlaid cotton mat, and one of ordinary skill in the art would find it obvious that these materials would provide at least some directional wicking), wherein the first wicking layer and the second wicking layer (2, Fig. 1) are coupled together by a bond (seam 18, Fig. 12) surrounding the absorbent material (1, Figs. 1 and 12) and the opening (19, Fig. 12), and wherein the absorbent material (1, Figs. 1 and 12) surrounds the opening (19, Fig. 12). The shell allows the absorbent to swell as needed, and prevents exudate from flowing back into the wound while still allowing the improved conformability of the dressing due to the slit and seam of the shell (¶ [0022-0030, 0041-0048, 0063, 0086, 0124]).
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 fluid management assembly of Allen with the teachings of Riesinger to have the articulation zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and have the absorbent material surrounded by at least one wicking layer, wherein the absorbent material surrounds the opening, as taught by Riesinger. This structure of fluid management assembly allows the absorbent to swell as needed, and prevents exudate from flowing back into the wound while still allowing the improved conformability of the dressing due to the slit and seam of the shell (¶ [0022-0030, 0041-0048, 0063, 0086, 0124]).
Regarding Claim 27, Allen further discloses the first zone and the second zone are coplanar and configured to be positioned substantially parallel to a treatment surface at the tissue site (as seen in Images 1-3; when placed on the wound, the absorbent material will be substantially parallel to the treatment surface of the tissue site).
Regarding Claim 30, Allen further discloses the first zone includes a first absorbent capacity that is less than a second absorbent capacity of the second zone (as seen in Images 1-3, the second zones are larger than the first zones and therefore have a larger absorbent capacity than the first zones).
Regarding Claim 31, Allen further discloses at least one relief area (see Image 1) positioned on opposing sides of the first zone (see Image 1).
Regarding Claim 33, Allen further discloses the fluid management assembly comprises a first axis (central longitudinal axis of Images 1 and 3) that is perpendicular to a second axis, wherein the first axis and the second axis each extend along the first zone and intersect at the first zone (the second axis can be any line perpendicular to the central longitudinal axis that extends through the first zone of Images 1 and 3), wherein the second zone is positioned outbound and coplanar to the first zone (see Images 1 and 3), and wherein the second zone is configured to absorb more fluid than the first zone (as seen in Images 1 and 3, the second zones are larger than the first zones and therefore are configured to absorb more fluid than the first zones).
Claims 13, 14, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al (US 2015/0216733) in view of Riesinger (US 2012/0095419) further in view of Collinson et al (US 2016/0144084).
Regarding Claims 13 and 14, Allen/Riesinger is silent whether the at least one relief area is a plurality of relief areas, wherein the articulation zone further comprises a plurality of fluid pockets, and wherein the plurality of relief areas are separated from each other by the fluid pockets, wherein the plurality of fluid pockets and the plurality of relief areas alternate along the opposing sides of the articulation zone.
Collinson teaches a wound dressing, thus being in the same field of endeavor, with a fluid distribution zone (main portion 520, Fig. 5B) and an articulation zone (combination of bridge portion 530 and additional portions 540, Fig. 5B), where the articulation zone (530 and 540, Fig. 5B) comprises at least one relief area (gaps 560, Fig. 5B) positioned on opposing sides of the articulation zone (530 and 540, Fig. 5B), wherein the at least one relief area is a plurality of relief areas (560, Fig. 5B), wherein the articulation zone (530 and 540, Fig. 5B) further comprises a plurality of fluid pockets (540, Fig. 5B), and wherein the plurality of relief areas (560, Fig. 5B) are separated from each other by the fluid pockets (540, Fig. 5B), wherein the plurality of fluid pockets (540, Fig. 5B) and the plurality of fluid pockets (540, Fig. 5B) and the plurality of relief areas (560, Fig. 5B) alternate along the opposing sides of the articulation zone (530 and 540, Fig. 5B). This structure provides enhanced side flexibility of the dressing to improve the coverage of a curved or arcuate wound (¶ [0161]).
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 articulation zone of Allen/Riesinger to have a plurality of relief areas separated from each other by a plurality of fluid pockets, wherein the plurality of fluid pockets and the plurality of relief areas alternate along the opposing sides of the articulation zone, as taught by Collinson. This structure provides enhanced side flexibility of the dressing to improve the coverage of a curved or arcuate wound (as motivated by Collinson ¶ [0161]).
Regarding Claim 32, Allen/Riesinger is silent whether the at least one relief area is a plurality of relief areas, wherein the first zone further comprises a plurality of fluid pockets, and wherein the plurality of relief areas are separated from each other by the fluid pockets.
Collinson teaches a wound dressing, thus being in the same field of endeavor, with a second zone (main portion 520, Fig. 5B) and a first zone (combination of bridge portion 530 and additional portions 540, Fig. 5B), where the first zone (530 and 540, Fig. 5B) comprises at least one relief area (gaps 560, Fig. 5B) positioned on opposing sides of the first zone (530 and 540, Fig. 5B), wherein the at least one relief area is a plurality of relief areas (560, Fig. 5B), wherein the first zone (530 and 540, Fig. 5B) further comprises a plurality of fluid pockets (540, Fig. 5B), and wherein the plurality of relief areas (560, Fig. 5B) are separated from each other by the fluid pockets (540, Fig. 5B). This structure provides enhanced side flexibility of the dressing to improve the coverage of a curved or arcuate wound (¶ [0161]).
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 articulation zone of Allen/Riesinger to have a plurality of relief areas separated from each other by a plurality of fluid pockets, as taught by Collinson. This structure provides enhanced side flexibility of the dressing to improve the coverage of a curved or arcuate wound (as motivated by Collinson ¶ [0161]).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781