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 04/16/2026 is 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. Locke/Greener is now cited to disclose the claimed 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, 5-17, 20, 24, 27, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al (US 2017/0189236) in view of Greener (US 2020/0107965).
Regarding Claim 1, Locke discloses a system (102, Fig. 1) for treating a tissue site (104, Fig. 1), comprising:
a dressing (124, Fig. 1) comprising:
a base layer (132, Fig. 1) including a periphery (152, Fig. 1) surrounding a central portion (156, Fig. 1),
a sealing member (140, Fig. 1) including a periphery (164, Fig. 1) and a central portion (168, Fig. 1), the periphery (164, Fig. 1) of the sealing member (140, Fig. 1) positioned proximate to the periphery (152, Fig. 1) of the base layer (132, Fig. 1), wherein the central portion (168, Fig. 1) of the sealing member (140, Fig. 1) and the central portion (156, Fig. 1) of the base layer (132, Fig. 1) define an enclosure (172, Fig. 1), and
a fluid management assembly (144, Fig. 1) disposed in the enclosure (172, Fig. 1), the fluid management assembly (144, Fig. 1) further comprising an absorbent material (184, Fig. 1) positioned in fluid communication between a first wicking layer (176, Fig. 1) and a second wicking layer (180, Fig. 1; ¶ [0077]), wherein the first wicking layer (176, Fig. 1) is coupled to the second wicking layer (180, Fig. 1) by a bond (187, Fig. 1; ¶ [0078]) that entirely surrounds the absorbent material (184, Fig. 1); and
a reduced-pressure source (128, Fig. 1) configured to be coupled in fluid communication with the enclosure (172, Fig. 1; ¶ [0094]).
Locke is silent whether the fluid management assembly includes an articulation zone and a fluid dispersion zone, wherein the articulation zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and wherein the fluid dispersion zone is configured to offload fluid away from the articulation zone, and wherein the bond entirely surrounds the opening at the articulation zone, and wherein the absorbent material entirely surrounds the opening.
Greener teaches a negative pressure wound dressing, thus being in the same field of endeavor, with a foam layer (424, Fig. 4C) which can include a plurality of openings (internal cut outs 499, Fig. 6A; see Image 1), wherein the foam material entirely surrounds the plurality of openings (as seen in Fig. 6A). Greener also indicates the cutouts can be distributed throughout the foam layer or localized to a center portion of the layer (¶ [0083]). As such, Greener envisions a foam layer as seen in Fig. 6A where the cut outs are localized to the center one-third of the layer. These cut outs provide the dressing with improved conformability, making the dressing more comfortable for a user to wear (¶ [0083]).
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 absorbent layer of Locke to have a plurality of openings, wherein the absorbent material entirely surrounds the plurality of openings, where the plurality of openings are localized to the center one-third of the absorbent layer, as taught by Greener. This provides the dressing with improved conformability, making the dressing more comfortable for a user to wear (as motivated by Greener ¶ [0083]). The combination of Locke/Greener will therefore have a fluid management assembly with an articulation zone (center one-third of absorbent layer of Locke/Greener) and a fluid dispersion zone (the outer two-thirds of absorbent layer of Locke/Greener), wherein the articulation zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and wherein the fluid dispersion zone is configured to offload fluid away from the articulation zone. The fluid dispersion zone of Locke/Greener will be configured to offload fluid away from the articulation zone as the fluid dispersion zone will not have any cut outs, and will therefore be more absorbent than the articulation zone which has a plurality of cut outs. The bond between the first and second wicking layers of Locke/Greener will also entirely surround the opening at the articulation zone, as the bond entirely surrounds the absorbent layer and therefore surrounds any structures within the absorbent layer such as the plurality of cut outs.
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Image 1: Annotated Fig. 6A of Greener
Regarding Claim 5, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the articulation zone (center one-third of absorbent layer comprising a plurality of cut outs of Locke/Greener) and the fluid dispersion zone (outer two-thirds of the absorbent layer of Locke/Greener) are coplanar and configured to be positioned substantially parallel to a treatment surface at the tissue site.
Regarding Claim 6, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the fluid dispersion zone (outer two-thirds of the absorbent layer of Locke/Greener) comprises a plurality of fluid dispersion zones (each outer third of the absorbent layer of Locke/Greener is one fluid dispersion zone, so therefore there are two fluid dispersion zones), wherein at least one of the fluid dispersion zones (each outer third of the absorbent layer of Locke/Greener) is positioned at each opposing end of the fluid management assembly, and wherein the articulation zone (center one-third of absorbent layer comprising a plurality of cut outs of Locke/Greener) is positioned between the fluid dispersion zones (each outer third of the absorbent layer of Locke/Greener).
Regarding Claim 7, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
In a different interpretation of Locke/Greener, the cut outs of Locke/Greener can be localized only on an edge portion, and therefore can be localized to one edge of the absorbent layer (as motivated by Greener ¶ [0083]). In this interpretation, the articulation zone (edge portion with plurality of cut outs) is positioned at a first end of the fluid management assembly and the fluid dispersion zone (remainder of layer without cut outs) is positioned at an opposing second end of the fluid management assembly.
Regarding Claims 8 and 9, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the fluid dispersion zone (outer two-thirds of the absorbent layer of Locke/Greener) is configured to absorb more fluid than the articulation zone (center one-third of absorbent layer comprising a plurality of cut outs of Locke/Greener; the center one-third will absorb less because it is smaller and additional has material removed via the cut outs). Therefore, the articulation zone includes a first absorbent capacity that is less than a second absorbent capacity of the fluid dispersion zone of Locke/Greener.
Regarding Claim 10, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the articulation zone (center one-third of absorbent layer comprising a plurality of cut outs of Locke/Greener) is free of absorbent (the cut outs specifically are free of absorbent, and therefore portions of the articulation zone is free of absorbent).
Regarding Claim 11, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the opening (cut outs within absorbent layer of Locke/Greener) is disposed through the fluid management assembly (the cut outs are disposed through a portion of the fluid management assembly).
Regarding Claims 12-14, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses at least one relief area positioned on opposing sides of the articulation zone, wherein 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 by each other by the fluid pockets, and wherein the plurality of fluid pockets and the plurality of relief areas alternate along the opposing sides of the articulation zone (see Image 1).
Regarding Claims 15 and 16, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the fluid management assembly comprises a first axis (longitudinal axis) that is perpendicular to a second axis (lateral axis), wherein the first axis and the second axis each extend along the articulation zone and intersect at the articulation zone (since the articulation zone is the center one-third of the absorbent layer, the longitudinal and lateral axes of the dressing will intersect in the center of the articulation zone), wherein the fluid dispersion zone is positioned outbound and coplanar to the articulation zone (since the articulation zone is the center one-third of the dressing, the fluid dispersion zone is outbound and coplanar to the articulation zone), and wherein the fluid dispersion zone is configured to absorb more fluid than the articulation zone (the center one-third will absorb less because it is smaller and additional has material removed via the cut outs), and wherein the fluid management assembly has a substantially symmetrical shape across at least one of the first axis and the second axis (see Fig. 4A of Locke; the dressing of Locke/Greener is square).
Regarding Claim 17, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Locke/Greener further discloses the articulation zone (the center one-third of the absorbent layer of Locke/Greener) is in fluid communication with the fluid dispersion zone (outer two-thirds of the absorbent layer of Locke/Greener) from a first end of the fluid management assembly to an opposing second end of the fluid management assembly.
Regarding Claim 20, Locke further discloses the base layer (132, Fig. 1) includes a plurality of apertures (160, Fig. 1) disposed through the periphery (152, Fig. 1) and the central portion (156, Fig. 1), the system (102, Fig. 1) further comprising an adhesive (136, Fig. 1) disposed on a surface (¶ [0074]) of at least a periphery (162, Fig. 1) of the sealing member (140, Fig. 1) and configured to extend through the apertures (160, Fig. 1) at least in the periphery (152, Fig. 1) of the base layer (132, Fig. 1) to contact tissue surrounding the tissue site (104, Fig. 1; ¶ [0067]).
Regarding Claim 24, Locke discloses a dressing (124, Fig. 1) for treating a tissue site (104, Fig. 1), comprising:
a base layer (132, Fig. 1) configured to be positioned at the tissue site (104, Fig. 1; the base layer is fully capable of being positioned directly onto the tissue site);
a sealing member (140, Fig. 1) configured to cover the base layer (132, Fig. 1) and to form a fluid seal relative to the tissue site (104, Fig. 1; ¶ [0074]); and
a fluid management assembly (144, Fig. 1) positioned between the base layer (132, Fig. 1) and the sealing member (140, Fig. 1), the fluid management assembly (144, Fig. 1) further comprising an absorbent material (184, Fig. 1) surrounded by at least one wicking layer (176, 180, Fig. 1).
Locke is silent whether the fluid management assembly includes a first zone and a second zone, wherein the first zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and wherein the second zone is configured to offload fluid away from the first zone and the articulation area, and wherein the absorbent material entirely surrounds the opening.
Greener teaches a dressing with a foam layer (424, Fig. 4C) which can include a plurality of openings (internal cut outs 499, Fig. 6A; see Image 1), wherein the foam material entirely surrounds the plurality of openings (as seen in Fig. 6A). Greener also indicates the cutouts can be distributed throughout the foam layer or localized to a center portion of the layer (¶ [0083]). As such, Greener envisions a foam layer as seen in Fig. 6A where the cut outs are localized to the center one-third of the layer. These cut outs provide the dressing with improved conformability, making the dressing more comfortable for a user to wear (¶ [0083]).
Therefore, it would have been obvious to modify the absorbent layer of Locke to have a plurality of openings, wherein the absorbent material entirely surrounds the plurality of openings, where the plurality of openings are localized to the center one-third of the absorbent layer, as taught by Greener. This provides the dressing with improved conformability, making the dressing more comfortable for a user to wear (as motivated by Greener ¶ [0083]). The combination of Locke/Greener will therefore have a fluid management assembly with a first zone (center one-third of absorbent layer of Locke/Greener) and a second zone (the outer two-thirds of absorbent layer of Locke/Greener), wherein the first zone includes at least one opening configured to be positioned at an articulation area at the tissue site, and wherein the second zone is configured to offload fluid away from the first zone. The second zone of Locke/Greener will be configured to offload fluid away from the first zone as the second zone will not have any cut outs, and will therefore be more absorbent than the first zone which has a plurality of cut outs.
Regarding Claim 27, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 24.
The combination of Locke/Greener further discloses the first zone (center one-third of absorbent layer comprising a plurality of cut outs of Locke/Greener) and the second zone (outer two-thirds of the absorbent layer of Locke/Greener) are coplanar and configured to be positioned substantially parallel to a treatment surface at the tissue site.
Regarding Claim 30, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 24.
The combination of Locke/Greener further discloses the second zone (outer two-thirds of the absorbent layer of Locke/Greener) is configured to absorb more fluid than the first zone (center one-third of absorbent layer comprising a plurality of cut outs of Locke/Greener; the center one-third will absorb less because it is smaller and additional has material removed via the cut outs). Therefore, the first zone includes a first absorbent capacity that is less than a second absorbent capacity of the second zone of Locke/Greener.
Regarding Claims 31-32, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 24.
The combination of Locke/Greener further discloses at least one relief area positioned on opposing sides of the first zone, wherein 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 by each other by the fluid pockets (see Image 1).
Regarding Claim 33, Locke/Greener discloses the claimed invention substantially as claimed as set forth above for Claim 24.
The combination of Locke/Greener further discloses the fluid management assembly comprises a first axis (longitudinal axis) that is perpendicular to a second axis (lateral axis), wherein the first axis and the second axis each extend along the first zone and intersect at the first zone (since the first zone is the center one-third of the absorbent layer, the longitudinal and lateral axes of the dressing will intersect in the center of the first zone), wherein the second zone is positioned outbound and coplanar to the first zone (since the first zone is the center one-third of the dressing, the second zone is outbound and coplanar to the first zone), and wherein the second zone is configured to absorb more fluid than the first zone (the center one-third will absorb less because it is smaller and additional has material removed via the cut outs).
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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