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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/19/2026 has been entered.
Response to Amendment
The amendments filed on 01/19/2026 has been entered. Claims 1-2, 4-6, 9-10, 12-14, 16, 32-33, 38-39, and 49-50, 52, and 56-57 are pending in this application. Claims 1, 9, 38 are amended. Claims 56-57 are newly added. Claims 3, 7-8, 11, 15, 17-31, 34-37, 40-48, 51, and 53-55 are cancelled.
Response to Argument
Applicant’s arguments with respect to claim(s) 1 and 38 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.
Though overall the same prior art references are used herein, at least applicant’s amendment to
independent claim 1 and 38 required a change in the grounds of rejection as detailed below in the prior art rejection.
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.
Claim(s) 1-2, 4-6, 9-10, 12-14, 16, 32-33, 38-39, 49-50, 52, and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2018/0353338 A1), hereby referred to as “Locke ‘338”, in view of Locke et al. (Publication No. US 2014/0012213 A1), hereby referred to as “Locke ‘213”, and Dozier et al. (Patent No. US 7,135,606 B1).
Regarding claim 1, Locke ‘338 teaches a dressing for treating a tissue site with instillation therapy (dressing 104; Paragraph 0027-0028; Figure 8), the dressing comprising:
a first layer comprising a polymer film having a plurality of passages through the polymer film (layer 210 is a polymer film with fluid restrictions 220; Figure 8; Paragraph 0048-0050, 0054, and 0084);
a second layer adjacent to the first layer (layer 805 adjacent to layer 210; Figure 8; Paragraph 0084), the second layer having a plurality of apertures (layer 805 has perforations 810; Figure 8; Paragraph 0084);
an adhesive layer on at least a portion of the first layer (low-tack adhesive can be on the tissue facing side of the second layer 210; Paragraph 0091; Figure 8); and
a third layer on the adhesive layer (release liner 245 is on the adhesive layer of layer 210; Paragraph 0057 and 0091; Figure 8), the third layer being at least partially removable from the adhesive layer (Paragraph 0057). Locke ‘338 does not teach the third layer further comprising:
a plurality of passages through the third layer, wherein the plurality of passages through the third layer are aligned with the plurality of passages through the first layer.
However, Locke ‘213 teaches the third layer further comprising:
a plurality of passages through the third layer (first release layer 158 with apertures 166 through the layer; Figure 6; Paragraph 0041-0042), wherein the plurality of passages through the third layer are aligned with the plurality of passages through the first layer (apertures 166 of the first release layer 158 is alighted with the apertures 146 of layer 144; Paragraph 0042; Figure 6).
Locke ‘213 and Locke ‘338 are considered to be analogous to the claimed invention because they are in the same field of wound dressings. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘338 to incorporate the teachings of Locke ‘213 and have the third layer of Locke ‘338 to have the plurality of passages that are aligned with the passages of the first layer, as taught by Locke ‘213. This allows for the aligned protection of the adhesive areas surrounding the passages (Locke ‘213; Paragraph 0042).
The combination of Locke ‘338 in view of Locke ‘213 does not teach a plurality of perforations forming a plurality of regions, the regions being separable from each other.
However, Dozier teaches a plurality of perforations forming a plurality of regions (perforation lines form concentric regions on release sheet 20; Figure 1-2; Column 2, lines 25-37), the regions being separable from each other (concentric regions are separable from each other to selectively expose adhesive; Figure 1-2; Column 2, lines 25-37).
Dozier and Locke ‘338 in view of Locke ‘213 are considered to be analogous to the claimed invention because they are in the same field of wound dressings. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘338 in view of Locke ‘213 to incorporate the teachings of Dozier and have the concentric perforations with a plurality of regions of Dozier on the third layer of Locke ‘338 in view of Locke ‘213. This allows for the removal of the release sheet from the bottom surface to selectively expose adhesive to the patient’s skin (Dozier; Column 2, line 55 to Column 3, line 3).
Regarding claim 2, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. Locke ‘338 further teaches wherein the third layer is not adhesive (release liner 245 does not have adhesive; Paragraph 0057).
Regarding claim 4, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. Locke ‘338 further teaches wherein the passages of the first layer comprise a plurality of fenestrations (perforations 810 in layer 805 are fenestrations; Paragraph 0084; Figure 8).
Regarding claim 5, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 4. Locke ‘338 further teaches wherein the passages of the third layer comprise a plurality of fenestrations (passages 220 of layer 210 are fenestrations; Figure 8; Paragraph 0082).
Regarding claim 6, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 5. The combination of Locke ‘338 in view of Locke ‘213 and Dozier further teaches wherein the plurality of regions are configured in a tessellate pattern or in concentric rings (Dozier; plurality of regions is inner circle and outer circle; Figure 1-2; Column 2, line 55 to Column 3, line 3).
Regarding claim 9, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. The combination of Locke ‘338 in view of Locke ‘213 and Dozier further teaches wherein one of the plurality of regions of the third layer includes a pull tab (Dozier; outer concentric ring has tab 21; Figure 1-2; Column 2, lines 25-37).
The combination of Locke ‘338 in view of Locke ‘213 and Dozier does not teach wherein each of the plurality of regions of the third layer includes the pull tab.
Since the applicant has not disclosed that placing a second pull tab on the inner concentric circle does anything more than produce predictable results (i.e. provide additional options of pulling the release sheet from the inside out), the mere duplication of the pull tab is not considered to have patentable significance. Therefore it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention, to modify Locke ‘338 in view of Locke ‘213 and Dozier to include a second pull tab on the inner concentric circle, in order to predictably have an additional options to the user to pull the release sheet from the inner circle to the outer concentric ring. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
Regarding claim 10, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. The combination of Locke ‘338 in view of Locke ‘213 and Dozier does not teach wherein the adhesive layer comprises a polyurethane adhesive, an acrylic adhesive, or a silicone adhesive.
However, Locke ‘338 teaches that the adhesive can be a silicone or acrylic adhesive (Paragraph 0007).
Locke ‘338 considered to be analogous to the claimed invention because they are in the same field of flow actuators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (low tack adhesive of Locke ‘338) for another (low tack acrylic adhesive of Locke ‘338) since the substitution of the energy applied would have yielded predictable results, namely, adhering the release liner to the third layer. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B.).
Regarding claim 12, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. Locke ‘338 further teaches wherein:
the second layer is a manifold (layer 805 is a manifold because it assists in collecting fluid through the dressing; Figure 8; Paragraph 0084), comprising a first surface and a second surface opposite the first surface (layer 805 has a first surface facing the tissue of the patient and a second surface facing the cover 116; Figure 8); and
the first layer is adjacent to the first surface (layer 210 is adjacent to the first surface of layer 805; Figure 8).
Regarding claim 13, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 12. Locke ‘338 further teaches further comprising:
a fourth layer adjacent the second surface of the second layer (layer 205 is adjacent to the second surface of layer 805; Figure 8), the fourth layer comprising a polymer film having a plurality of fluid restrictions through the polymer film (layer 205 can be made of polymeric fusion bonded film (Supracore) with apertures and fluid pathways; Paragraph 0045).
Regarding claim 14, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 13. Locke ‘338 further teaches further comprising:
a fifth layer adjacent to the fourth layer (layer 116 is adjacent to layer 205; Figure 8), the fifth layer comprising a polymer drape (layer 116 is a cover/drape that is a polymeric film; Figure 8; Paragraph 0027 and 0037-0038).
Regarding claim 16, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 12. Locke ‘338 further teaches further comprising:
a fourth layer adjacent the second surface of the second layer (layer 205 is adjacent to the second surface of layer 805; Figure 8), the fourth layer comprising a gel (Paragraph 0045).
Regarding claim 32, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. Locke ‘338 further teaches wherein the passages of at least the first layer comprise or consist essentially of elastomeric valves in the polymer film, and the elastomeric valves are normally closed (passages 220 of layer 210 are elastomeric valves in the polymer film that are normally closed; Paragraph 0054).
Regarding claim 33, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. Locke ‘338 further teaches wherein the passages of at least the first layer comprise one or more of fenestrations, slits, and intersecting slits in the polymer film (Paragraph 0054-0055).
Regarding claim 38, Locke ‘338 teaches a system for treating a tissue site (system 100; Paragraph 0027-0028), comprising:
a dressing (dressing 104; Paragraph 0027-0028; Figure 8), the dressing including:
a first layer comprising a polymer film having a plurality of fluid restrictions through the polymer film (layer 210 is a polymer film with fluid restrictions 220; Figure 8; Paragraph 0048-0050, 0054, and 0084);
a second layer adjacent to the first layer (layer 805 adjacent to layer 210; Figure 8; Paragraph 0084), the second layer comprising a polymer having a plurality of apertures (layer 805 has perforations 810 and made of polyurethane film; Figure 8; Paragraph 0084);
an adhesive layer on at least a portion of the first layer (low-tack adhesive can be on the tissue facing side of the second layer 210; Paragraph 0091; Figure 8); and
a third layer on the adhesive layer (release liner 245 is on the adhesive layer of layer 210; Paragraph 0057 and 0091; Figure 8), the third layer being at least partially removable from the adhesive layer (Paragraph 0057), and
a source of instillation solution (solution source 118; Figure 1; Paragraph 0028). Locke ‘338 does not teach the third layer further comprising: a plurality of fluid restrictions through the third layer.
However, Locke ‘213 teaches the third layer further comprising: a plurality of fluid restrictions through the third layer (first release layer 158 with apertures 166 through the layer; Figure 6; Paragraph 0041-0042).
Locke ‘213 and Locke ‘338 are considered to be analogous to the claimed invention because they are in the same field of wound dressings. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘338 to incorporate the teachings of Locke ‘213 and have the third layer of Locke ‘338 to have the plurality of passages that are aligned with the passages of the first layer, as taught by Locke ‘213. This allows for the aligned protection of the adhesive areas surrounding the passages (Locke ‘213; Paragraph 0042).
The combination of Locke ‘338 in view of Locke ‘213 does not teach a plurality of perforations forming a plurality of concentric regions, the concentric regions being separable from each other, and the concentric regions including an outer ring.
However, Dozier teaches a plurality of perforations forming a plurality of concentric regions (perforation lines form concentric regions on release sheet 20; Figure 1-2; Column 2, lines 25-37), the concentric regions being separable from each other (concentric regions are separable from each other to selectively expose adhesive; Figure 1-2; Column 2, lines 25-37), and the concentric regions including an outer ring (outer concentric ring and inner circle; Figure 1-2).
Dozier and Locke ‘338 in view of Locke ‘213 are considered to be analogous to the claimed invention because they are in the same field of wound dressings. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘338 in view of Locke ‘213 to incorporate the teachings of Dozier and have the concentric perforations with a plurality of regions of Dozier on the third layer of Locke ‘338 in view of Locke ‘213. This allows for the removal of the release sheet from the bottom surface to selectively expose adhesive to the patient’s skin (Dozier; Column 2, line 55 to Column 3, line 3).
The combination of Locke ‘338 in view of Locke ‘213 and Dozier does not teach wherein the plurality of fluid restrictions through the third layer are not located in the outer ring.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the outer ring of Dozier be aligned with the outer border of the third layer, not comprising the passageways of Locke ‘338 in view of Locke ‘213, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether having passageways or not on the outer ring of Locke ‘338 in view of Locke ‘213 and Dozier, with the common function at either locations of protecting the adhesive layer of the dressing, in re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
Regarding claim 39, Locke ‘338 in view of Locke ‘213 and Dozier teaches the system of claim 38. Locke ‘338 further teaches wherein the third layer is a non-adhesive third layer (release liner 245 does not have adhesive; Paragraph 0057).
Regarding claim 49, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 38. Locke ‘338 further teaches wherein the second layer is a manifold (layer 805 is a manifold because it assists in collecting fluid through the dressing; Figure 8; Paragraph 0084) comprising a first surface and a second surface opposite the first surface (layer 805 has a first surface facing the tissue of the patient and a second surface facing the cover 116; Figure 8), the first layer adjacent the first surface (layer 210 is adjacent to the first surface of layer 805; Figure 8).
Regarding claim 50, Locke ‘338 in view of Locke ‘213 and Dozier teaches the system of claim 38. Locke ‘338 further teaches further comprising:
a fourth layer adjacent a second side of the second layer (layer 205 is adjacent to the second surface of layer 805; Figure 8), the fourth layer comprising a polymer film having a plurality of fluid restrictions through the polymer film (layer 205 can be made of polymeric fusion bonded film (Supracore) with apertures and fluid pathways; Paragraph 0045).
Regarding claim 52, Locke ‘338 in view of Locke ‘213 and Dozier teaches the system of claim 38. Locke ‘338 further teaches further comprising:
a fourth layer adjacent a second side of the second layer (layer 205 is adjacent to the second surface of layer 805; Figure 8), the fourth layer comprising a gel (Paragraph 0045).
Regarding claim 56, Locke ‘338 in view of Locke ‘213 and Dozier teaches the dressing of claim 1. The combination of Locke ‘338 in view of Locke ‘213 and Dozier further teaches wherein the plurality of regions of the third layer configured in concentric regions (Dozier; perforation lines form concentric regions on release sheet 20; Figure 1-2; Column 2, lines 25-37), the concentric regions including an outer ring (Dozier; outer concentric ring and inner circle; Figure 1-2). The combination of Locke ‘338 in view of Locke ‘213 and Dozier does not teach wherein the plurality of passages through the third layer are not located in the outer ring.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the outer ring of Dozier be aligned with the outer border of the third layer, not comprising the passageways of Locke ‘338 in view of Locke ‘213, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether having passageways or not on the outer ring of Locke ‘338 in view of Locke ‘213 and Dozier, with the common function at either locations of protecting the adhesive layer of the dressing, in re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
Regarding claim 57, Locke ‘338 in view of Locke ‘213 and Dozier teaches the system of claim 38. The combination of Locke ‘338 in view of Locke ‘213 and Dozier further teaches wherein the plurality of fluid restrictions through the third layer are aligned with the plurality of fluid restrictions through the first layer (Locke ‘213; apertures 166 of the first release layer 158 is alighted with the apertures 146 of layer 144; Paragraph 0042; Figure 6).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781