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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 22 and 34 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. Claims 22 and 34 are rejected under 35 USC 103 using Melin as a single reference with teachings applied from an alternative embodiment as set forth in the rejection below.
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 22-24, 27-35, 51-55 are rejected under 35 U.S.C. 103 as being unpatentable over Melin (US 20160144085 A1).
Regarding Claim 22, Melin discloses a dressing for treating an abdominal tissue site (Fig 1, 2 ¶[0050-0051] combination of fluid transport dressing 16, fluid transport member 18, and wound cover 20 adapted to treat an abdominal tissue site), comprising:
a fenestrated manifold comprising a first liquid-impermeable layer having a plurality of fenestrations (Figs 1, 2, 5 ¶[0073][0094] bottom sheet 32 is made of a liquid impermeable material that achieves permeability via a plurality of slits 48), wherein the fenestrated manifold has a first side and a second side (Fig 2, first side of 32 is the lower surface thereof, and the second side of 32 is the upper side adjacent sealed chambers 28);
a bubble manifold comprising a second liquid-impermeable layer and a plurality of bubbles formed on the second liquid-impermeable layer (Fig 2, ¶[0068][0073] the bubble manifold is the combination of top sheet 30 and intermediate sheet 34. Top sheet 30 is made of a liquid impermeable material with a plurality of sealed chambers 28 formed thereon by intermediate sheet 34) wherein the bubble manifold has a first side and a second side (Fig 2, first side of 30 is the lower surface of 30 including sealed chambers 28, and the second side is the upper side of 30); and
a foam manifold adapted to be positioned adjacent a central portion of the bubble manifold (Fig 1, ¶[0051-0052] fluid transport member 18 comprises a foam material and is disposed adjacent a central portion of dressing 16 as shown in Fig 1);
and a layer of liquid-impermeable material positioned over the foam manifold and coupled to one or both of the bubble manifold and the fenestrated manifold (Fig 1 ¶[0061] wound cover member 20 is coupled to one or both of the bubble manifold and the fenestrated manifold by virtue of its connection to fluid transport member 18. Wound cover member 20 is implicitly liquid-impermeable based on the fluid flow lines shown in Fig 1, where fluid only flows through an opening in wound cover member 20. Furthermore, the cover 20 is necessarily liquid impermeable to allow sufficient negative pressure to be applied to the dressing.)
The first embodiment of Melin does not explicitly disclose that a layer of liquid impermeable material positioned over the foam manifold and coupled in contact with one or both of the bubble manifold and the fenestrated manifold.
However, Melin teaches an alternative embodiment of the wound dressing (Fig 7 ¶[0098-0099]), wherein a layer of liquid impermeable material (Fig 7, wound cover 20) positioned over the foam manifold (Fig 7, wound filler 60) and coupled in contact with one or both of the bubble manifold and the fenestrated manifold (Fig 7, wound cover 20 is disposed in direct contact with fluid transport dressing 16) to provide bridging functionality to the dressing, allowing treatment of wounds that are difficult to access normally (¶[0033]).
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 first embodiment of Melin so that a layer of liquid impermeable material positioned over the foam manifold and coupled in contact with one or both of the bubble manifold and the fenestrated manifold, as taught by Melin, to provide bridging functionality to the dressing, allowing treatment of wounds that are difficult to access normally (as motivated by Melin ¶[0033]).
Regarding Claim 23, Melin discloses that the bubble manifold is adapted to be positioned adjacent the fenestrated manifold such that the first side of the bubble manifold is in contact with the second side of the fenestrated manifold (Fig 2, first side of 30 with sealed chambers 28 is in contact with the second, upper side of 32), and wherein the foam manifold is positioned between the layer of liquid-impermeable material and the second side of the bubble manifold (Fig 1, fluid transport member 18 is positioned between wound cover member 20 and the second, upper side of 30).
Regarding Claim 24, Melin discloses that the foam manifold comprises a foam member and the layer of liquid-impermeable material is adapted to form a seal around the foam member with the bubble manifold (Fig 1, wound cover member 20 covers the dressing 16 and thus forms a seal around the bubble manifold 30).
Regarding Claim 27, Melin discloses that the plurality of bubbles comprises closed cells containing a fluid (Fig 2 ¶[0075] plurality of sealed chambers 28 are closed and may be filled with air).
Regarding Claim 28, Melin discloses that the bubble manifold further comprises apertures formed in the second liquid-impermeable layer, wherein the apertures are positioned between the plurality of bubbles (Fig 2, Fig 5, ¶[0068][0093] top sheet 30 may comprise a plurality of slits 39. Fig 5 shows the top sheet 30 with no sealed chambers; however, ¶[0068] envisions that the sealed chambers may be formed on the top sheet 30, bottom sheet 32, or both. When the sealed chambers 28 are formed on the top sheet 30 as shown in Fig 2, the slits 39 would necessarily be disposed between the sealed chambers 28, because otherwise sealed chambers 28 would not be sealed).
Regarding Claim 29, Melin discloses that the plurality of bubbles protrude from the first side of the bubble manifold and are adapted to be in contact with the second side of the fenestrated manifold (Fig 2, first side of 30 with sealed chambers 28 protruding therefrom is in contact with the second, upper side of 32).
Regarding Claim 30, Melin discloses that each of the plurality of bubbles has a diameter of between about 1 mm and 5 mm (¶[0071] sealed chambers 28 may have a diameter of 3 mm).
Regarding Claim 31, Melin discloses that the second liquid-impermeable layer of the bubble manifold comprises a first sheet of polymeric film and a second sheet of polymeric film, wherein inner surfaces of each of the first sheet of polymeric film and the second sheet of polymeric film are sealed to each other to form a sealed region comprising the plurality of bubbles having closed cells (Fig 2, ¶[0068][0072-0073][0076] the bubble manifold is the combination of top sheet 30 and intermediate sheet 34, both made of a polymeric film, where 30 is the first sheet and 34 is the second sheet that are sealed to one another to form sealed chambers 28).
Regarding Claim 32, Melin discloses that the bubble manifold comprises a central portion and a plurality of fluid channels that extend radially away from the central portion towards a perimeter of the dressing (Fig 2, Fig 5 ¶[0068][0077] combination of 30 and 34 creates void spaces 36 between the sealed chambers 28 which act as fluid conduits. When dressing 16 is circular as shown in Fig 5, the void spaces 36 between sealed chambers 28 extend radially from the central portion of 30. Fig 5 shows the top sheet 30 with no sealed chambers; however, ¶[0068] envisions that the sealed chambers may be formed on the top sheet 30, bottom sheet 32, or both).
Regarding Claim 33, Melin discloses that the plurality of bubbles are positioned along each of the plurality of fluid channels, and wherein the plurality of bubbles protrude from the first side of the bubble manifold (Fig 2, Fig 5 ¶[0068][0077], fluid channels created by void spaces 36 are between sealed chambers 28. When dressing 16 is circular as shown in Fig 5, the void spaces 36 between sealed chambers 28 extend radially from the central portion of 30 and thus the plurality of sealed spaces 28 are positioned along each of the plurality of fluid channels. Fig 5 shows the top sheet 30 with no sealed chambers; however, ¶[0068] envisions that the sealed chambers may be formed on the top sheet 30, bottom sheet 32, or both).
Regarding Claim 34, Melin discloses a method for treating an abdominal tissue site (Fig 1 ¶[0001-0003][0025][0050]. Fig 1 shows placement of negative pressure wound therapy system 10 at a wound floor 12 beneath an abdominal wall 14), comprising:
positioning a tissue interface comprising a first polymeric layer and a plurality of bubbles at the abdominal tissue site (Fig 1-2, combination of fluid transport member 18 and fluid transport dressing 16 comprises first polymeric layer 30 and a plurality of sealed chambers 28 positioned at the wound floor 12 beneath an abdominal wall 14); the tissue interface further comprising a foam manifold (Fig 1, fluid transport member 18) and a film extending over the foam manifold that is coupled to a surface of the polymeric layer (Fig 1, central portion of wound cover 20 extending over 18 is coupled to 30 by virtue of its connection to 18),
covering the tissue interface and the abdominal tissue site with a drape to provide a fluid seal around the tissue interface and the abdominal tissue site (Fig 1, ¶[0061] wound cover 20 is adhered to the skin surrounding the abdominal wound, thus sealing the fluid transport dressing 16); and
providing negative pressure from a negative-pressure source coupled to the tissue interface and the abdominal tissue site (Fig 1 ¶[0051] negative pressure source 21 is coupled to dressing 16 and wound site 12).
The first embodiment of Melin does not explicitly disclose that a film extending over the foam manifold that is coupled in contact with a surface of the polymeric layer.
However, Melin teaches an alternative embodiment of the wound dressing (Fig 7 ¶[0098-0099]), wherein a film (Fig 7, wound cover 20) extends over the foam manifold (Fig 7, wound filler 60) and is coupled in contact with a surface of the polymeric layer (Fig 7, wound cover 20 is disposed in direct contact with fluid transport dressing 16) to provide bridging functionality to the dressing, allowing treatment of wounds that are difficult to access normally (¶[0033]).
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 first embodiment of Melin so that a film extending over the foam manifold is coupled in contact with a surface of the polymeric layer, as taught by Melin, to provide bridging functionality to the dressing, allowing treatment of wounds that are difficult to access normally (as motivated by Melin ¶[0033]).
Regarding Claim 51, Melin discloses that each of the plurality of bubbles has a height of between about 1 mm and 5 mm (Fig 2 ¶[0070-0071] sealed chambers 28 may have a height within the range of 0.3-0.7 of the diameter of the sealed chamber, said diameter may be 3, 6, 8, or 25mm. 0.7 of 3mm would result in a sealed chamber height of 2.1 mm).
Regarding Claim 52, Melin discloses that the second liquid-impermeable layer has a thickness of between about 50 pm and 150 pm (Fig 2 ¶[0074] top and bottom sheets 30, 32 as well as intermediate sheet 34 may have a thickness of 0.1 mm, or 100 µm).
Regarding Claim 53, Melin discloses that the plurality of bubbles have a volumetric shape that is any one of a hemispherical, spherical, conical, cylindrical, ovoid, and cuboidal shape (¶[0070] sealed chambers may be cylindrical).
Regarding Claim 54, Melin discloses that the plurality of bubbles comprises: a first group of bubbles positioned in a central portion of the bubble manifold, wherein each bubble of the first group of bubbles has a first diameter; and a second group of bubbles positioned in a peripheral portion of the bubble manifold, wherein each bubble of the second group of bubbles has a second diameter; wherein the second diameter is greater than the first diameter (Fig 5 sealed chambers 28 may have a first group in a central position 42 with a first diameter, with a second group of sealed chambers 28 extending radially outward from the center 42 toward the periphery, having a second diameter. Fig 5 shows the top sheet 30 with no sealed chambers; however, ¶[0068] envisions that the sealed chambers may be formed on the top sheet 30, bottom sheet 32, or both).
Melin does not explicitly disclose that the second diameter is greater than the first diameter.
However, Melin teaches that the diameters of the bubbles may vary (¶[0071] the sealed chamber may have a diameter that is one of the following: 3, 6, 9 or 25 mm. Assuming, as a non-limiting example, that the height of the sealed chamber is approximately half the diameter of the sealed chamber, the volume of the sealed chamber is approximately 10 mm.sup.3 for a sealed chamber with a diameter of 3 mm, approximately 80 mm.sup.3 for a sealed chamber with a diameter of 6 mm, approximately 280 mm.sup.3 for a sealed chamber with a diameter of 9 mm and approximately 6000 mm.sup.3 for a sealed chamber with a diameter of 25 mm.
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 second plurality of bubbles to have a greater diameter than the first plurality of bubbles because it would have been obvious to try based on the teachings of Melin describing different possible bubble diameters with the recognized need to provide a cushioning effect to the dressing and to prevent clogging of the dressing (¶[0007-0008]) and because there are a finite of possible solutions (1. First and second pluralities of bubbles having the same diameter; 2. First plurality of bubbles having a larger diameter than the second plurality of bubbles; and 3. First plurality of bubbles having a smaller diameter than the second plurality of bubbles). One of ordinary skill would recognize the reasonable expectation of success of providing a cushioning effect to the dressing and to prevent clogging of the dressing (as motivated by Melin ¶[0007-0008]).
Regarding Claim 55, Melin discloses that the plurality of bubbles comprises: a first group of bubbles positioned in a central portion of the bubble manifold, wherein the first group of bubbles has a first spacing distance; and a second group of bubbles positioned in a peripheral portion of the bubble manifold, wherein the second group of bubbles has a second spacing distance; wherein the second spacing distance is greater than the first spacing distance (Fig 5 sealed chambers 28 may have a first group in a central position 42 with a first spacing distance, with a second group of sealed chambers 28 extending radially outward from the center 42, thus the second group of sealed chambers 28 have a second spacing distance that is greater than the first spacing distance, with the greatest spacing distance at the periphery of 16. Fig 5 shows the top sheet 30 with no sealed chambers; however, ¶[0068] envisions that the sealed chambers may be formed on the top sheet 30, bottom sheet 32, or both).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Melin (US 20160144085 A1) in view of Simmons (US 20110224631 A1).
Regarding Claim 25, Melin is silent whether the plurality of bubbles comprises open-celled blisters.
However, Simmons teaches a wound dressing, thus from the same field of endeavor, wherein the plurality of bubbles comprises open-celled blisters (Fig 2 ¶[0040-0041] shows a plurality of bubbles formed from liquid impermeable layers 204 and 206 comprising fenestrations 203) to distribute reduced pressure and remove fluids (¶[0040]).
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 dressing of Melin so that the plurality of bubbles comprises open-celled blisters, as taught by Simmons to distribute reduced pressure and remove fluids (as motivated by Simmons ¶[0040]).
Regarding Claim 26, the Examiner recognizes claim 26 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim 26 requires the plurality of bubbles to comprise the following structural elements in addition to those in the claims from which they depend: Open celled blisters formed in the second liquid impermeable layer of the bubble manifold. As set forth above for claim 25, the plurality of bubbles taught by Simmons comprise open celled blisters formed from a liquid impermeable layer analogous to the second liquid impermeable layer of Melin.
In the prior art rejection in this Office action, Examiner considers claim 26 to be met when a reference teaches these structural limitations as set forth above for claim 25.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Melin (US 20160144085 A1) in view of Blott (US 20150209492 A1).
Regarding Claim 36, Melin is silent regarding delivering a therapeutic fluid from a fluid source to the tissue interface.
However, Blott teaches a wound therapy system, thus from the same field of endeavor, including delivering a therapeutic fluid from a fluid source to the tissue interface (Fig 1 ¶[0501-0502], fluid supply tube 7 delivers therapeutic fluid from reservoir 12 to the wound 5) to return cleansed fluid containing materials that are beneficial in promoting wound healing to the wound (¶[0501]).
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 method of Melin to include delivering a therapeutic fluid from a fluid source to the tissue interface, as taught by Blott to return cleansed fluid containing materials that are beneficial in promoting wound healing to the wound (as motivated by Blott ¶[0501]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781