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 .
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.
Claims 62-73 are rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al. (US 2002/0161346 A1) in view of Locke et al. (WO 2019/177683 A1).
Regarding claim 62, Lockwood discloses a barrier (Figs. 1-7, feat. 20; ¶0072-0080; Fig. 31, feat. 419; ¶0111) comprising: a base layer (20; ¶0076) having a bottom surface (22) and a top surface (24) and at least one edge therebetween (Figs. 2-5), the base layer defining a plurality of fluid channels extending radially from a center of the base layer toward at least one edge of the base layer (Figs. 2-3 and 5, feat. 28; ¶0076); and a plurality of structures extending from the bottom surface of the base layer and imparting thickness to the barrier (Figs. 5 and 7, feats. 32, 34, and 40; ¶0078-0080: channels 32 and 34 in the bottom wound contacting surface 22 are 0.762 mm deep and define open spaces 40 between the wound surface 18 and the base layer/barrier 20); and wherein the barrier is configured to be positioned with the plurality of structures adjacent to wound tissue (¶0078-0080).
Lockwood does not disclose that the plurality of structures are configured to provide an offset to reduce or prevent tissue ingrowth or that the plurality of structures are positioned on the bottom surface of the base layer in a repeating pattern.
Locke teaches a tissue interface (Figs. 2 and 25, feat. 108; ¶0073 and 00131-00132) for a negative pressure wound therapy dressing system comprising a bubble manifold (Figs. 2, 10-15, and 25, feat. 202; ¶0073 and 00133). The bubble manifold (Figs. 10-15 and 25, feat. 202) comprises bubbles (210), and may additionally include interconnecting walls between the bubbles (Figs. 10-15, feat. 1024; ¶0097-00102), which protrude from the surface (502, 504) of the manifold towards the wound tissue (Fig. 25, feat. 2572; ¶00131) in order to space the manifold and tissue interface away from the wound tissue, which reduces or eliminates possible tissue ingrowth into the tissue interface (¶00142). Reducing or eliminating tissue ingrowth advantageously allows the dressing system to be applied to wounds for longer periods of time while maintaining the ability for the dressing to be easily removed (¶00142). The bubbles (Figs. 10-15, feat. 210), and interconnecting walls if they are present (1024), may either be positioned in a repeating staggered (Fig. 10) or non-staggered (Figs. 14-15) pattern (¶0087 and 00101). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the barrier disclosed by Lockwood so that the structures extending from the bottom surface are the bubbles taught by Locke, resulting in the plurality of structures being configured to provide an offset to reduce or prevent tissue ingrowth and the plurality of structures being positioned on the bottom surface of the base layer in a repeating pattern in order to allow the barrier to be applied to wounds for longer periods of time while maintaining the ability for the dressing to be easily removed as taught by Locke.
Regarding claim 63, Lockwood in view of Locke suggests the barrier of claim 62. Locke further teaches that the bubbles (Fig. 25, feat. 210) of the tissue interface (108) are in direct contact with the wound tissue (2572; ¶00133 and 00142). Therefore, Lockwood in view of Locke further suggests that the barrier is configured to be positioned with the plurality of structures in direct contact with the wound tissue.
Regarding claim 64, Lockwood in view of Locke suggest the barrier of claim 63, and Lockwood further discloses that the barrier is configured to be positioned within deep tracts or tunnels in a wound (Fig. 31, feat. 419; ¶0111). Regarding claim 65, Lockwood further discloses that the barrier further comprises an inlet extending from the top surface of the base layer, the inlet communicatively coupled to the plurality of fluid channels (Figs. 2-5, feat. 26; ¶0076). Regarding claim 66, Lockwood further discloses that the base layer and plurality of structures comprise a non-porous material (¶0072).
Regarding claims 67-69, Lockwood in view of Locke suggests the barrier of claim 62. As discussed above, Locke teaches that the protruding structures may include both bubbles (Figs. 10-15, feat. 210) and interconnecting walls between the bubbles (1024; ¶00097-00102). The bubbles (210) and interconnecting walls (1024) are different shapes (Figs. 10 and 15) and protrude to different heights (Figs. 11-13). Locke further teaches that the bubbles may be formed in a variety of shapes, such as hemispheres or cylindrical or tubular posts (¶0088). Therefore, Lockwood in view of Locke further suggests that the plurality of structures comprise repeating structures having at least two different shapes, with respect to claim 67, that the plurality of structures comprise structures of different heights, with respect to claim 68, and that the plurality of structures comprise walls and posts, with respect to claim 69.
Regarding claim 70, Lockwood in view of Locke suggest the barrier of claim 62, and Lockwood further discloses that the base layer further defines a plurality of perforations extending through the base layer (Figs. 2-5, feat. 36; ¶0079). Regarding claim 71, Lockwood further discloses that the barrier is configured to be transparent to allow for visualization of the wound tissue through the barrier (¶0013). Regarding claim 72, Lockwood further discloses that the barrier is configured to conform to a shape of the wound tissue (¶0013 and 0072). Regarding claim 73, Lockwood further discloses that the barrier is configured to be cut to a size and shape of the wound tissue (¶0013-0014).
Claims 74-81 are rejected under 35 U.S.C. 103 as being unpatentable over Lockwood in view of Svedman et al. (US 2011/0015619 A1) and in further view of Locke.
Regarding claim 74, Lockwood discloses a barrier for use in a tunnel wound (Figs. 1-7, feat. 20; ¶0072-0080; Figs. 26-27, feat. 219; ¶0107-0109), the barrier comprising: a base layer (Figs. 1-7, feat. 20; ¶0076; Figs. 26-27, feat. 220; ¶0108) comprising a non-porous molded polymer (¶0072-0075), the base layer defining a plurality of irrigation channels extending throughout the base layer (Figs. 2-3 and 5, feat. 28; ¶0076; Figs. 26-27, feat. 56; ¶0108), and the base layer further comprising: a head portion having a top surface and a bottom surface (Figs. 26-27, feat. 250; ¶0107), and a cylindrical portion extending from the bottom surface of the head portion (Figs. 26-27, feat. 252; ¶0107); an inlet positioned on the top surface of the head portion of the base layer, the inlet communicatively coupled to the plurality of irrigation channels (Figs. 26-27, feat. 23; ¶0108-0109).
Lockwood does not disclose that the polymer of the base layer is injection molded, that the top surface of the head portion is substantially flat such that the inlet is positioned on the flat top surface, or a plurality of structures extending outward from the cylindrical portion, the plurality of structures comprising at least a first shape positioned on the cylindrical portion in a repeating pattern, the plurality of structures configured to provide an offset to reduce or prevent tissue ingrowth by spacing the cylindrical portion of the base layer from walls of the tunnel wound.
Svedman teaches a negative pressure wound therapy dressing system (Figs. 1a and 6, feat. 11; ¶0044) for tunnel wounds (W; ¶0042) comprising a cylindrical part for insertion into the tunnel portion of the wound (11A, 11B; ¶0044) and a flat substrate extending above the tunnel portion, and at the head, of the wound dressing, but not beyond the margins surrounding the wound (¶0045). The flat substrate advantageously aids with distributing vacuum pressure evenly (¶0066). In the barrier disclosed by Lockwood, the inlet both supplies irrigation fluids and vacuum pressure to the wound (Lockwood: Figs. 26-27, feat. 23; ¶0108-0109). Modifying the barrier disclosed by Lockwood so that the head has a flat surface in order to aid the even distribution of vacuum pressure as taught by Svedman would require the inlet of Lockwood to be placed on the flat top surface in order for the flat top surface of the head to distribute the vacuum pressure provided from the inlet. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the barrier disclosed by Lockwood so that the top surface of the head portion is substantially flat such that the inlet is positioned on the flat top surface in order to aid with the even distribution of vacuum pressure as taught by Svedman.
Lockwood in view of Svedman does not suggest that the polymer of the base layer is injection molded or that the barrier comprises a plurality of structures extending outward from the cylindrical portion, the plurality of structures comprising at least a first shape positioned on the cylindrical portion in a repeating pattern, the plurality of structures configured to provide an offset to reduce or prevent tissue ingrowth by spacing the cylindrical portion of the base layer from walls of the tunnel wound.
Locke teaches a tissue interface (Figs. 2 and 25, feat. 108; ¶0073 and 00131-00132) for a negative pressure wound therapy dressing system comprising a bubble manifold (Figs. 2, 10-15, and 25, feat. 202; ¶0073 and 00133). The bubble manifold (Figs. 10-15 and 25, feat. 202) comprises bubbles (210), and may additionally include interconnecting walls between the bubbles (Figs. 10-15, feat. 1024; ¶0097-00102), which protrude from the surface (502, 504) of the manifold towards the wound tissue (Fig. 25, feat. 2572; ¶00131) in order to space the manifold and tissue interface away from the wound tissue, which reduces or eliminates possible tissue ingrowth into the tissue interface (¶00142). Reducing or eliminating tissue ingrowth advantageously allows the dressing system to be applied to wounds for longer periods of time while maintaining the ability for the dressing to be easily removed (¶00142). The bubbles (Figs. 10-15, feat. 210), and interconnecting walls if they are present (1024), may either be positioned in a repeating staggered (Fig. 10) or non-staggered (Figs. 14-15) pattern (¶0087 and 00101). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the barrier suggested by Lockwood in view of Svedman so that the barrier comprises a plurality of structures extending outward from the cylindrical portion, the plurality of structures comprising at least a first shape positioned on the cylindrical portion in a repeating pattern, the plurality of structures configured to provide an offset to reduce or prevent tissue ingrowth by spacing the cylindrical portion of the base layer from walls of the tunnel wound in order to allow the barrier to be applied to wounds for longer periods of time while maintaining the ability for the dressing to be easily removed as taught by Locke.
Lockwood in view of Svedman and in further view of Locke is silent with respect to the polymer of the base layer being injection molded. However, the patentability of a product does not depend on its method of production. If the product of a claim is the same as or obvious from a product of the prior art, the claim is unpatentable even if the prior product was made by a different process. Please see MPEP §2113(I). In this case, Lockwood in view of Svedman and in further view of Locke discloses or renders obvious all the elements of the barrier of claim 74, except for the polymer of the base layer being injection molded. However, Lockwood discloses that the polymer of the base layer is a non-porous molded polymer (¶0072-0075), and merely does not disclose that the molding process is injection molding. Injection molding a non-porous polymer to form the claimed barrier would not be expected to impart distinctive structure characteristics compared to using other polymer molding methods to form the claimed barrier, especially considering that Lockwood discloses that the non-porous polymer forming the claimed barrier may be polyethylene (¶0072), which is a thermoplastic polymer commonly employed in injection molding. Therefore, the claimed base layer of the barrier being injection molded does not have patentable weight in view of the prior art.
Regarding claims 75-77, Lockwood in view of Svedman and in further view of Locke suggests the barrier of claim 74. As discussed above, Locke teaches that the repeating protruding structures may include both bubbles (Figs. 10-15, feat. 210) and interconnecting walls between the bubbles (1024; ¶00097-00102). The bubbles (210) and interconnecting walls (1024) are different shapes (Figs. 10 and 15) and protrude to different heights (Figs. 11-13). Locke further teaches that the bubbles may be formed in a variety of shapes, such as hemispheres or cylindrical or tubular posts (¶0088). Therefore, Lockwood in view of Svedman and in further view of Locke further suggests that the plurality of structures comprises the first shape and a second shape positioned on the cylindrical portion in a repeating pattern, with respect to claim 75, that the plurality of structures comprise structures of different heights, with respect to claim 76, and that the first shape is a wall and the second shape is a post, with respect to claim 77.
Regarding claim 78, Lockwood in view of Svedman and in further view of Locke suggests the barrier of claim 74, and Lockwood further discloses that at least the cylindrical portion of the base layer is configured to be cut to a size of the tunnel wound (¶0013). Regarding claim 79, Lockwood further discloses that the base layer comprises a plurality of perforations formed through the cylindrical portion (Figs. 26-27, feat. 36; ¶0079 and 0107-0109; Please note that ¶0107-0109 label the holes as 46, but Figs. 26-27 label the holes as 36, which is consistent with other embodiments, such as described in ¶0079).
Regarding claim 80, Lockwood in view of Svedman and in further view of Locke suggests the barrier of claim 79. Locke further teaches apertures or perforations (Figs. 2 and 10-15, feat. 212) in the surface from which the structures protrude to allow for fluid transfer (¶0073 and 0077). Because the apertures or perforations are formed at the base of the protruding bubble structures (210), they are formed under the bubble structures. Therefore, Lockwood in view of Svedman and in further view of Locke further suggests that at least a subset of the plurality of perforations are formed under a portion of a structure of the plurality of structures.
Regarding claim 81, Lockwood in view of Svedman and in further view of Locke suggests the barrier of claim 74, and Lockwood further discloses that the barrier is configured to be transparent to allow for visualization of the tunnel wound through the barrier (¶0013).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tout et al. (US 2013/0123723 A1) discloses a tunnel wound dressing.
Locke (US 2020/0000643 A1) discloses deep wound filler for preventing ingrowth.
Olson (US 2008/0300555 A1) discloses a negative pressure wound dressing with structures preventing ingrowth.
Radl (US 2008/0132819 A1) discloses a tunnel wound dressing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
