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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2026 has been entered.
Response to Amendment
The amendment filed 05/19/2026 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 Claims 70-76, 87-89, 92, 95-97, 100 and 103-104 are withdrawn.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 with respect to claim(s) 77 have been considered but are moot because the new ground of rejection does not rely the same interpretation of Cotton in view of Hunt for any teaching or matter specifically challenged in the argument.
A new grounds of rejection is made relying on modifying the layer 65 of Cotton such that it is a film, as taught by Hunt. The rejection no longer relies on modifying the tissue interface of Cotton such that it comprises the film of Hunt. The lower wall 30 of Hunt is configured to be exposed to the tissue site (Hunt ¶ 0015) and it is thus obvious to modify the layer 65 of Cotton which contacts the tissue site (Cotton ¶ 0079) such that it is a film, as taught by Hunt.
Accordingly, claim 77 is 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 (foam pad 66), a sealing layer (silicone gel layer (91), and an additional layer (three-dimensional textile material 65) positioned between the manifold and the sealing layer (fig. 13);
A plurality of passages configured to permit liquid flow through the additional layer (¶ 0069, ¶ 0091), wherein the sealing layer comprises a gel including at least one aperture through the gel fluidly coupled to more than one of the plurality of passages in the additional layer (additional layer spans across the aperture fig. 13 and includes regular array of openings ¶ 0069, ¶ 0154);
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), and wherein more than one of the plurality of passages in the additional layer are configured to be directly exposed to the tissue site through the at least one aperture in the sealing layer (fig. 13, ¶ 0069).
Cotton fails to disclose that the additional layer is a film.
Hunt teaches (fig. 1) an apparatus (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 film (lower wall 30 of elastomeric sheet 38) (¶ 0030);
A plurality of passages (holes 34) configured to permit liquid flow through the film (¶ 0035); and
Wherein more than one of the plurality of passages in the film are configured to be directly exposed to the tissue site (¶ 0015); and
Wherein the film resists wound adhesion and is appropriate for placement in direct contact with tissue surfaces (¶ 0030).
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 additional layer of Cotton such that it is a film, as taught by Hunt, as a film resists wound adhesion and is appropriate for placement in direct contact with tissue surfaces (Hunt ¶ 0030).
Regarding claim 78, Cotton in view of Hunt disclose wherein the film is configured to be interposed between the manifold and the tissue site (Cotton, fig. 13). Cotton further 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, Cotton fig. 13).
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), such film being suitable for use in a dressing (¶ 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 (Lauer ¶ 0026).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bishop et al.(Pub. No.: US 2019/0133830 A1) discloses an apparatus having a sealing layer including at least one aperture. Gilman (US Pat. No.: 5,106,362) discloses a tissue interface comprising a manifold, a sealing layer, and a film.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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