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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/26/26 has been entered.
Status of Claims
Claims 1-6 and 9-16 are currently pending, with claims 10-16 being withdrawn from consideration.
Response to Arguments
Applicant’s arguments, see pages 5-8 of Applicant’s Remarks, filed 02/26/26, with respect to the rejections of claims 1-6 and 9 under 35 U.S.C. 103 as being unpatentable over Canner in view of Hartwell have been fully considered and are not persuasive.
Applicant argues that Hartwell does not disclose, teach, or suggest that the benefit of enhanced preferential collapse has any relation to the thickness of the slots (Fig. 13A, feat. 1303) being thinner than the surrounding material. Applicant further argues that because Hartwell teaches that the benefit of enhanced preferential collapse is derived from the empty space, Hartwell teaches that configurations other than that of Applicant’s would also receive the benefit of enhanced preferential collapse, and that therefore there would not be a motivation to modify the layer disclosed by Canner to reach the claimed configuration without improper hindsight.
However, Hartwell states “the empty space will permit the wound closure device to preferentially collapse in a direction when a force is applied in a direction perpendicular to the slots 1303. Because the empty space is easier to compress than the remainder of the foam, the width and thickness of the foam will preferably not (or minimally) compress compared to the resulting compression perpendicular to the length of the wound closure device 1301” (emphasis added by the examiner). Therefore, Hartwell teaches that the interaction between the empty space and “the width and thickness of the remaining foam” influences the degree of collapse, and, as a result, the degree of preferential collapse. Therefore, the benefit of enhanced preferential collapse is associated both with the empty space and the thickness of the remaining foam.
Claim Interpretation
Claim 1 recites “a thickness of the walls of the porous material around the plurality of voids is greater than a thickness of the plurality of voids”. As written, it is not clear which axis or plane of the claimed layer that the “thickness” is in reference to. Based on paragraphs 0067-0068 and figure 4 of the present specification, the claimed “thickness” appears to correspond to the reference indicator “Tv” in Figure 4, which is in the plane formed by the longitudinal axis “L” and lateral axis “W”, and is perpendicular to the vertical axis “T”, and the “thickness” of claim 1 was interpreted as such.
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 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Canner et al. (US 2016/0287765 A1) in view of Hartwell (US 2017/0007462 A1).
Regarding claim 1, Canner discloses a compressive layer (Figs. 13A-16, feat. 6000; ¶0313-0330: stabilizing structure 6000 is analogous to the claimed compressive layer) for use with a deep abdominal wound dressing (¶0010-0011 and 0033), the compressive layer comprising: a body (Figs. 13B, 14A, and 16, feats. 6002, 6006, 6010; ¶0314-0315, 0320, and 0330) formed of a porous material (¶0172, 0173, and 0323: the stabilizing structure may be made of an open celled foam) having a plurality of voids (6004 and 6018) defined by walls of the porous material (¶0172, 0173, and 0323: since the stabilizing structure may be made of open celled foam, the voids 6004 and 6018 would be defined by walls of the open celled foam) configured to compress along a lateral axis and a longitudinal axis and to resist compression along a vertical axis (¶0321), the body including a first portion of the plurality of voids having an elongate shape extending along the longitudinal axis that are configured to compress along the lateral axis (Annotated Fig. 14A and 16, feats. A; ¶0321) and a second portion of the plurality of voids positioned in a pattern that converges toward the longitudinal axis at opposing ends of the body around at least a portion of the first portion of the plurality of voids (Annotated Figs. 14 and 16, feats. B), wherein at least one of the second portion of the plurality of voids intersect the longitudinal axis proximate each opposing end of the body (Annotated Fig. 16, feat. B).
Canner does not disclose that a thickness of the walls of the porous material around the plurality of voids is greater than a thickness of the plurality of voids.
Hartwell teaches a compressive layer for use with a deep abdominal wound dressing (Fig. 13A, feat. 1301; ¶0155-0156) comprising slot shaped voids (1303) extending along the longitudinal axis of the compressive layer such that the voids are thinner than the surrounding material (Fig. 13A). Hartwell teaches that this advantageously enhances the preferential collapse and compression of the layer perpendicular to the length of the layer, i.e. in the lateral direction (¶0155-0156). 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 layer disclosed by Canner so that a thickness of the walls of the porous material around the plurality of voids is greater than a thickness of the plurality of voids as taught by Hartwell so that preferential compression of the layer in the lateral direction is enhanced as taught by Hartwell.
[AltContent: textbox (Annotated Figures 14A and 16 of Canner: Features A are the first portion of the plurality of voids. Features B are the second portion of the plurality of voids.)]
Regarding claim 2, Canner in view of Hartwell suggests the compressive layer of claim 1, and Hartwell further discloses that the vertical axis is substantially perpendicular to each of the lateral axis and the longitudinal axis (¶0016 and 0321).
Regarding claim 3, Canner in view of Hartwell suggests the layer of claim 1. Hartwell further teaches that the empty space of the slot shaped voids results in differences in compressibility of the layer in the longitudinal (lengthwise), lateral (widthwise), and vertical (thickness) directions (¶0155-0156), and therefore differences in the moduli of elasticity in each of the directions. Hartwell further teaches that the thickness of the layer resists compression to the greatest extent and that the longitudinally oriented slots (Fig. 13A, feat. 1303) cause preferential compression in the lateral direction, perpendicular to the longitudinal direction (¶0155-0156), and therefore that the modulus of elasticity in the vertical direction is the highest, the modulus of elasticity in the lateral direction is the smallest, and that the modulus of elasticity in the longitudinal direction is between the two. Therefore, Canner in view of Hartwell further suggests that the plurality of voids forms a first modulus of elasticity along at least one of the lateral axis and the longitudinal axis, wherein the porous material of the body into which the plurality of voids are disposed forms a second modulus of elasticity along at least one of the lateral axis and the longitudinal axis, and a third modulus of elasticity along the vertical axis, and wherein the first modulus of elasticity is smaller than the second modulus of elasticity and the third modulus of elasticity, and wherein the second modulus of elasticity is smaller than the third modulus of elasticity.
Regarding claim 4, Canner in view of Hartwell suggests the compressive layer of claim 1, and Canner further discloses that the plurality of voids is formed by at least one of felting and cutting (¶0323: the stabilizing structure 6000 may be cut out of a solid block of material).
Regarding claim 5, Canner in view of Hartwell suggests the compressive layer of claim 1, and Canner further discloses that at least one of a shape or a pattern of the plurality of voids is selected based on material properties of the body (¶0318, 0321, and 0324-0329).
Regarding claim 6, Canner in view of Hartwell suggests the compressive layer of claim 1, and Canner further discloses that the body and the voids form a manifold configured to distribute negative pressure and/or add or remove fluids (¶0168-0170, 0286, and 0323: the cells may have or be made of porous material suitable for distributing negative pressure and removing wound fluids).
Regarding claim 9, Canner in view of Hartwell suggests the compressive layer of claim 1, and Canner further discloses that the voids of the plurality of voids are shaped and curved and form concentric rings that generally follow a contour of the body (Figs. 16 and 24-25c show concentric rings of voids).
Conclusion
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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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781