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 Amendment
The amendment filed 01/08/2026 has been entered. Claims 1-69, 80, 84-86, 90-91, 93-94, 98-99, 101-102, 105-111 are cancelled. Claims 70-79, 81-83, 87-89, 92, 95-97, 100, 103-104 remain pending in this application. Claims 70-76, 87-89, 92, 95-97, 100 and 103-104 are withdrawn.
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not persuasive.
Applicant argues that the rationale for Cotton in view of Hunt fails to establish a prima facie case of obviousness.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that the lower wall 30 does not comprise a gel and does not function as a sealing layer or otherwise provide a seal relative to tissue. However, the lower wall 30 of Hunt is configured to be placed in direct contact with the tissue site. Thus, the lower wall 30 of Hunt is considered to be analogous to the sealing layer of the claimed invention. Further, the lower wall 30 of Hunt is cited to teach the position of the film layer with respect to the tissue interface, the lower wall 30 being positioned between a manifold and a sealing layer. Applicant argues that the lower wall 30 does not reasonably provide any linking teachings that would lead a person of skill in the art to modify Cotton to include the film of Hunt. However, as discussed in the rejection below, providing the film of Hunt aids in the dispersion of flow such that clogs of exuded fluids and accompanying debris is prevented (Hunt, ¶ 0037).
Applicant argues that Hunt teaches the benefit of fluid dispersion requires offset holes and that modifying Cotton to include the film of Hunt without offset holes would not aid in fluid dispersion according to Hunt. However, claim 77 requires that “at least one aperture through the gel fluidly coupled to more than one of the plurality of passages in the film”. Cotton discloses additional apertures (perforations 92) where, when modified with the film having the plurality of passages of Hunt, would be offset and provide the benefit of fluid dispersion at the location of the perforations in the border region of the sealing layer (Cotton, fig. 13-14).
Accordingly, claim 77 remains obvious over Cotton in view of Hunt and a prima facie case of obviousness has been established.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 77-78, 81-83 are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (Pub. No.: US 2014/0309574 A1) in view of Hunt et al. (Pub. No.: US 2004/0030304 A1).
Regarding claim 77, Cotton discloses (fig. 13) discloses an apparatus (wound dressing 90) for treating a tissue site with negative pressure (¶ 0153), the apparatus comprising:
A tissue interface comprising a manifold (absorbent pad 66) and a sealing layer (silicone gel layer 91);
Wherein the sealing layer comprises a gel (¶ 0154) including at least one aperture through the gel (¶ 0154); and
A cover (backing layer 61) configured to be attached to the tissue site (¶ 0147);
Wherein the cover and the tissue interface are assembled in a stacked relationship with the cover configured to be attached to an attachment surface adjacent to the tissue site (fig. 13, ¶ 0147).
Cotton fails to disclose the tissue interface comprising a film positioned between the manifold and the sealing layer; a plurality of passages configured to permit liquid flow through the film, wherein the at least one aperture is fluidly coupled to more than one of the plurality of passages in the film; and wherein more than one of the plurality of passages in the film are configured to be directly exposed to the tissue site through the at least one aperture in the sealing layer.
Hunt teaches (fig. 1) an apparatus (wound dressing 10) for treating a tissue site with negative pressure (abstract) and thus in the same field of endeavor, the apparatus comprising a tissue interface comprising a manifold (upper foam layer 12), a sealing layer (lower wall 30 of elastomeric sheet 38), and a film (upper wall 28 of elastomeric sheet 38, ¶ 0030) positioned between the manifold layer and the sealing layer (fig. 1); a plurality of passages (holes 32) configured to permit liquid flow through the film (see arrows, fig. 1, ¶ 0037).
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 tissue interface of Cotton such that it comprises the film of Hunt positioned between the manifold and the sealing layer, in order to aid in the dispersion of flow (Hunt ¶ 0037).
The apparatus of Cotton in view of Hunt such that the film of Hunt is positioned between the manifold and the sealing layer of Cotton further results in: the at least one aperture of the sealing layer fluidly coupled to more than one of the plurality of passages in the film; and wherein more than one of the plurality of passages in the film are configured to be directly exposed to the tissue site through the at least one aperture in the sealing layer, as it can be seen from Hunt fig. 1 that the plurality of passages in the film are dispersed across the film (Hunt, ¶ 0033) and from Cotton fig. 13 that the at least one aperture is a central opening formed slightly smaller than the manifold (Cotton, fig. 13, ¶ 0154).
Regarding claim 78, Cotton in view of Hunt disclose wherein the film is configured to be interposed between the manifold and the tissue site (see rejection of claim 77 above. Cotton discloses wherein the manifold comprises a hydrophobic material (e.g., polyurethane foam ¶ 0091).
Regarding claim 81, Cotton in view of Hunt disclose the film having a thickness of 50 microns (Hunt, ¶ 0021). Accordingly, Cotton in view of Hunt disclose wherein the film has a surface with height variations not exceeding 0.2 millimeters over 1 centimeter.
Regarding claim 82, Cotton in view of Hunt disclose wherein the sealing layer is adjacent to the film (see rejection of claim 77 above). Cotton discloses wherein the sealing layer is configured to contact the tissue site (¶ 0154).
Regarding claim 83, Cotton in view of Hunt disclose wherein the at least one aperture is further configured to permit at least some of the film to directly contact the tissue site (see rejection of claim 77 above).
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over Cotton in view of Hunt, as applied to claim 77 above, and further in view of Lauer (Pub. No.: US 2017/0095374 A1).
Regarding claim 79, Cotton in view of Hunt disclose wherein the film comprises a polymer film (Hunt, ¶ 0030).
Cotton in view of Hunt fail to disclose the polymer film having an area density less than 30 grams per square meter.
Lauer teaches (fig. 102) a dressing (bandage 10) and thus in the same filed of endeavor comprising a film (sheet 13), wherein the film comprises a polymer film (¶ 0023) having an area density less than 30 grams per square meter (¶ 0026).
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 polymer film of Cotton in view of Hunt such that it has an area density of less than 30 grams per square meter, as taught by Lauer, as such films are suitable for use in a dressing (¶ 0026 of Lauer).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Andresen et al. (Pub. No.: US 2011/0137271 A1) discloses a tissue interface comprising a manifold, a sealing layer, and a film positioned between the manifold and the sealing layer. Stickels et al. (Pat. No.: US 6,566,575 B1) discloses a tissue interface comprising a manifold, a sealing layer, and a film positioned between the manifold and the sealing layer. Gilman (Pat. No.: 5,056,510) discloses a tissue interface comprising a sealing layer including at least one aperture.
THIS ACTION IS MADE FINAL. 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.
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/MEAGAN NGO/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781