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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 14th, 2026 has been entered.
Claim Status
The amendment submitted on May 14th, 2026 has been entered. Claims 1-2, 6-7, 9, 13-14, 16, 19, 21-23, 25, 27-29, 33-35, 41-42, 47-50, and 52-55 are currently pending. Claims 1 and 13 have been amended. Claims 3, 8, 10-12, 15, 17-18, 20, 24, 26, 30-32, 36-40, 43-46, 51, and 56-63 have been cancelled. Claims 27-29, 33-35, 41-42, 47-50, and 52-55 have been withdrawn from consideration according to the above restriction as being drawn toward an unelected group. Thus, claims 1-2, 6-7, 9, 13-14, 16, 19, 21-23, and 25 are currently under consideration.
Response to Arguments
Applicant's arguments filed May 14th, 2026 have been fully considered but they are not persuasive. The current amended claim limitations are seen to overcome the prior rejection of record presented. However, in light of the teachings of Simmons et al. (U.S. Publication 2019/0307935), these newly amended claims are considered to have been obvious to one of ordinary skill in the art (see below rejection of claim 1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “perpendicular” in claim 1 in relation to “perpendicular bisector” is a relative term which renders the claim indefinite. The term “perpendicular” is not defined by the claim in that the claim does not define what the bisector is perpendicular to, the term perpendicular is defined as at a 90 degree angle to a given line, plane, or surface, yet the claim has failed to dictate to what line, plane, or surface the bisector is perpendicular to and as such it cannot be determined the degree to which the term perpendicular limits the scope of the claim and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not provide a standard for ascertaining the requisite degree as it describes a perpendicular bisector 402 that is perpendicular to a length Lca and a separate perpendicular bisector 406 that is perpendicular to a width WcAa. For the purposes of examination, the term “perpendicular bisector” is being interpreted to be a perpendicular bisector in relation to the length wherein it is perpendicular to, and bisecting, the length of one of the first portion of collapsible apertures.
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.
Claim(s) 1-2, 6-7, 9, 13-14, 21-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll et al. (WIPO Publication 2019/136164) in view of Locke et al. (U.S. Publication 2015/0320602) and further in view of Greener (U.S. Publication 2020/0107965) and Simmons et al. (U.S. Publication 2019/0307935).
Regarding claim 1, Carroll discloses (Fig. 6, apertures 415 presented in Fig. 17) a dressing 110 for treating a tissue site with negative pressure (Abstract), the dressing comprising: a fluid management layer 410 comprising polymer film (¶0061, polymer film) having a plurality of fluid restrictions 420 extending through the polymer film and configured to deform (¶0066 expand or open in response to a pressure gradient), and a manifold layer 405 coupled (¶0056 bonded to second layer 410) to the fluid management layer 410, the manifold layer 405 having a first surface facing the fluid management layer (side facing 410), a second surface (side facing 140) opposite the first surface, and a thickness (thickness can be seen in cross section shown in Fig. 12) extending between the first surface and the second surface.
The manifold layer comprises a plurality of apertures 415 extending at least partially through the thickness of the manifold layer from the first surface (¶00115 perforations may be a through-hole that extends through the first layer from a first surface adjacent to the cover to a second surface adjacent to the second layer 410); wherein an area of the first surface, the second surface, or both, when the manifold layer is subjected to negative pressure is decreased relative to the area of the first surface or the second surface when the manifold layer is not subjected to negative pressure (¶0108 changes in pressure cause first layer 405 to expand and contract; ¶0081 negative pressure in sealed environment may compress first layer; compression of the layer would inherently lead to a decrease in area of the first and second surfaces);
wherein the plurality of apertures comprise a first portion of apertures arranged in a first plurality of rows and a second portion of apertures arranged in a second plurality of rows (see illustrative diagram of Fig. 17 below);
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Illustrative diagram of Fig. 17 of Carroll.
Carroll does not expressly disclose the apertures being collapsible, the collapsible apertures themselves being configured to deform in response to the negative pressure, a line extending through a midpoint of a length of one of the first portion of collapsible apertures being perpendicular relative to the length and oriented through a midpoint of a width of at least one of the second portion of collapsible apertures, or a plurality of fluid apertures interposed among the plurality of collapsible apertures, each of the fluid apertures extending through the thickness of the manifold layer and through the first surface and the second surface.
Regarding the apertures being collapsible and the collapsible apertures themselves being configured to deform in response to the negative pressure, however, Locke, in the same field of endeavor of dressings for treating a tissue site with negative pressure (Abstract), teaches a manifold layer 314 comprising collapsible (¶0083 holes may collapse) apertures 328 that allow for the deformation/collapse of the contracting layer (¶0083 causing the contracting layer to collapse) for the purpose of applying a closing force substantially parallel to the surface of the tissue site to close the opening of a patient wound in response to application of the negative pressure ¶0005.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apertures of Carroll to have been collapsible upon the application of negative pressure, as taught by Locke, for the purpose of applying a closing force substantially parallel to the surface of the tissue site to close the opening of a patient wound in response to application of the negative pressure ¶0005.
Regarding a [[perpendicular bisector]] line extending through a midpoint of a length of one of the first portion of collapsible apertures being perpendicular relative to the length and oriented through a midpoint of a width of at least one of the second portion of collapsible apertures, Locke further teaches the plurality of collapsible apertures comprising a first portion of collapsible apertures arranged in a first plurality of rows and a second portion of collapsible apertures arranged in a second plurality of rows wherein a bisector 354 extends through a midpoint 336A of a length (center of aperture and thus midpoint of width and length, longitudinal dimension of aperture 328) of one of the first portion of collapsible apertures and a midpoint 336B of a width (center of aperture and thus midpoint of width and length) of at least one of the second portion of collapsible apertures and manipulating both the relative angle of the individual apertures to arrive at a perforation shape factor which adjusts based on the rotation of the aperture in relation to x and y-axis of the dressing (see Fig. 10-12 illustrating how rotation of the aperture affects the compression) and the position of the apertures in relation to one another to arrive at a strut angle and how both of these factors are results effective variable effecting the compressibility factor according to the equation detailed in ¶0095.
While Carroll in view of Locke do not expressly disclose or suggest the angle at which the lengths of the first and second portions of collapsible apertures are oriented toward one another, Greener, in the same field of endeavor of negative pressure wound therapy dressings, teaches providing apertures perpendicular to one another such that a line extending through a midpoint of a length, and perpendicular relative to said length, of a first portion of apertures arranged in a first plurality of rows would extend through the length of the first portion of apertures and through a midpoint of the width of a second portion of apertures in a plurality of rows (see below illustrative diagram of Greener Fig. 6A) for the purpose of providing the functionality of the slits to two different perpendicular directions of the device (¶0083 slits or cutouts that extend in two different directions, can conform and wrap around a contoured body region of a patient along both the length and width of the foam spacer).
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Illustrative diagram of Fig. 6A of Greener.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carroll in view of Locke to have oriented the apertures of the first and second portions of apertures such that a perpendicular bisector of a length of a first portion of apertures arranged in the first plurality of rows would extend through the length of the first portion of apertures and through a midpoint of the width of a second portion of apertures, as taught by Greener, as Locke teaches that changing the orientation of the aperture affects the compression characteristics within a particular axis of the device, such that as the longest dimension of an oval aperture is moved into line with the axis the perforation shape factor increases and thus increases closing force within that axis (Fig. 11 in line with axis of closing force 131 equals about 2 ¶0079 with Fig. 12 showing perpendicular to the axis has a perforation shape factor of about ½ ¶0080 with the compressibility factor being proportional to the perforation shape factor as shown in equation ¶0095 and the closing force being proportional to the compressibility factor shown in the equation in ¶0094) and as such it would have been obvious to one of ordinary skill in the art to providing the two sets of apertures perpendicular to one another such that a perpendicular bisector of a length of a first portion of apertures arranged in a first plurality of rows would extend through the length of the first portion of apertures and through a midpoint of the width of a second portion of apertures in a plurality of rows for the purpose of having the two sets of apertures provide equal closing forces to opposing perpendicular directions of the device in order to provide equal closing forces to both perpendicular axis of the device as taught by Greener.
Regarding the plurality of fluid apertures interposed among the plurality of collapsible aperture, each of the fluid apertures extending through the thickness of the manifold layer and through the first surface and the second surface, however, Simmons, in the same field of endeavor of negative pressure wound therapy dressings, teaches providing a plurality collapsible apertures (926 and 930) comprising a first portion of collapsible apertures (926) arranged in a first plurality of rows and a second portion of collapsible apertures (930) comprising a second plurality of rows, and a plurality of fluid apertures 932 interposed among the plurality of collapsible apertures (Fig. 20 shows interposed arrangement) that extend through (¶0111 through holes) the thickness of a manifold layer 874 for the purpose of facilitating lateral compression (¶0111 first plurality of voids is configured to facilitate lateral compression). Simmons further teaches the shape and orientation of the pore affecting the direction and extent to which compressive contraction occurs during application of negative pressure, with spherical shapes exhibiting an isotropic contraction along lateral 894 and longitudinal directions 890 perpendicular to a vertical 898 through direction of the holes (¶0057 pores may have a shape that is similar along the longitudinal axis, the lateral axis , and the vertical axis (spherical)) and elongation of the pores resulting anisotropic compression resulting in more compression in a perpendicular axis to the elongated axis (¶0057 in anisotropic compressive layers materials, the compressive layer material experiences different amounts of contraction in at least one of the lateral direction, the longitudinal direction, and/or the vertical direction…the pores may be elongate and oriented along a first axis, which can result in more compression in a second axis generally perpendicular to the first axis).
Furthermore, Locke, further teaches the shape of the perforation being directly proportional to the compressibility of the device and as such different shapes providing differing amounts of compression (¶0080 with the compressibility factor being proportional to the perforation shape factor as shown in equation ¶0095 and the closing force being proportional to the compressibility factor shown in the equation in ¶0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carroll in view of Locke and Greener to have included a plurality of fluid apertures interposed among the plurality of collapsible apertures, as taught by Simmons, for the purpose of providing a multitude of different shaped apertures that provide differing amounts of compression in lateral and longitudinal directions of the manifold layer as taught by Simmons (¶0057 in anisotropic compressive layers materials, the compressive layer material experiences different amounts of contraction in at least one of the lateral direction, the longitudinal direction, and/or the vertical direction…the pores may be elongate and oriented along a first axis, which can result in more compression in a second axis generally perpendicular to the first axis) and further supported by Locke (¶0080 with the compressibility factor being proportional to the perforation shape factor as shown in equation ¶0095 and the closing force being proportional to the compressibility factor shown in the equation in ¶0094).
Regarding claim 2, Carroll in view of Locke and further in view of Greener and Simmons suggests the dressing of claim 1. Carroll further discloses each of the apertures comprising:
a length (Fig. 17 element 415 longest dimension of ellipsoid within plane formed by axes 1405 and 1410) parallel to the first surface of the manifold layer; and a width (Fig. 17 element 415 shortest dimension of ellipsoid within plane formed by axes 1405 and 1410) parallel to the first surface of the manifold layer and perpendicular to the length, wherein the length of each of the plurality of collapsible apertures is greater than its width (length greater than width providing elongate elliptical shape of aperture)
Regarding claim 6, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll further discloses the plurality of collapsible apertures including the first portion of collapsible apertures having a first orientation and the second portion of collapsible apertures having a second orientation (Fig. shows two orientations of apertures 415).
Regarding claim 7, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll further discloses the first orientation deviating from the second orientation by between 75 degrees and 105 degrees (Fig. 17 shows the elliptical shapes oriented at an approximately 90 degree angle from one another in relation to the lengths of each ellipses).
Regarding claim 9, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 6. Carroll further discloses each of the first plurality of rows is adjacent to one of the second plurality of rows (rows of apertures 415 alternate between opposite facing directions as seen in Fig. 17).
Regarding claim 13, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll in view of Locke and Simmons further suggest providing the apertures of the device with different shapes to exhibit variable amounts of deformation in response to the negative pressure, as detailed in the rejection of claim 1 above, but do not expressly suggest which apertures would exhibit less deformation than others and thus do not expressly suggest the fluid apertures being configured to exhibit less deformation in response to the negative pressure applied to the manifold layer relative to the plurality of collapsible apertures.
However, it would have been obvious to try to one of ordinary skill in the art at the time the invention was made to have the fluid apertures exhibit less deformation than the plurality of collapsible apertures since the different apertures suggested by Carroll in view of Locke and Simmons are intended to exhibit differing amounts of deformation based on comprising different shapes which have been shown to exhibit differing amounts of deformation and there are only a finite number of predictable solutions. Either the fluid apertures exhibit more deformation or less deformation in a particular axis. Both Simmons and Locke suggest the ability to manipulate the shape of the apertures in order to exhibit a particular amount of deformation and Simmons suggests providing multiple shapes that would inherently exhibit less or more deformation based on which shape or axis is being compared, therefore whether the fluid apertures exhibit less deformation in a particular axis depends on the orientation and shape of the aperture as well as the particular axis being observed. Thus, having the fluid apertures exhibit less deformation in response to negative pressure would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp” and Simmons suggests providing different shapes that would exhibit different amounts of compression in particular axes of the manifold layer (see above rejection of claim 1). If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143. One of ordinary skill would have been expected to have been anticipated to be successful in modifying the device such that the fluid apertures exhibited less deformation since Simmons and Locke both suggest the ability to manipulate the shape and orientation of the apertures in order to manipulate deformation amounts in regards to particular axis of the device (see above rejection of claim 1).
Regarding claim 14, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll further discloses both the first surface and the second surface comprising a sculpted surface (¶00131 plurality of channels can be formed in a first surface of the block, ¶00131 channels may also be formed in a second surface of the block) comprising a plurality of fluid channels disposed within the sculpted surface (¶00131; each channel may run the length or width of the block; viewed from a side perpendicular to the first surface, the first surface may have an undulating topography similar toa square-wave shape; cut to variable depths showing disposal within the surface).
Regarding claim 21, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll in view of Locke do not expressly disclose the manifold layer comprising a closed-cell foam.
However, Locke, in the same field of endeavor of dressings for treating a tissue site with negative pressure (Abstract), further teaches the contracting layer being a closed-cell foam ¶0054.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the foam material of Carroll that performs the function of providing a foam layer in which apertures may be positioned and is compressible for the foam of Locke since these elements perform the same function of providing a compressible foam layer into which apertures can be applied. Simply substituting one foam layer for another would yield the predictable result of allowing a(n) layer to be compressible and include structured apertures within. See MPEP 2143.
Regarding claim 22, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll further discloses the manifold layer comprising a felted foam ¶00129.
Regarding claim 23, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll further discloses a polymer drape 140 coupled to the manifold layer opposite the fluid management layer (see arrangement of layers in Fig. 6).
Regarding claim 25, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll further discloses a contact layer 605 coupled to the fluid management layer opposite the manifold layer (see arrangement of layers in Fig. 6), the contact layer comprising a plurality of apertures 620.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll et al. (WIPO Publication 2019/136164) in view of Locke et al. (U.S. Publication 2015/0320602), Greener (U.S. Publication 2020/0107965), Simmons et al. (U.S. Publication 2019/0307935), and Asefi et al. (U.S. Publication 2022/0249763) with a filed date of May 7th, 2020.
Regarding claim 16, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 14. Carroll does not expressly disclose a first or second portion of fluid channels wherein the first portion of fluid channels intersect two or more of the second portion of fluid channels.
However, Asefi et al., in the same field of endeavor of negative pressure wound therapy devices, discloses providing a lattice of intersecting fluid channels, as can be seen in Fig. 6 (i), wherein a first portion of fluid channels (fluid channels 124 in a first direction) intersect with a second portion of fluid channels (fluid channels 124 in a second perpendicular direction) for the purpose of assisting the application of negative pressure across the whole width of the layer and also assist the passage of fluid from the layer to the vacuum conduit 111 (¶0143).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the channels of Carroll to have had first and second portions that intersected one another to form a lattice, as taught by Asefi, for the purpose of assisting the application of negative pressure across the whole width of the layer and also assist the passage of fluid from the layer to the vacuum conduit 111 (¶0143).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll et al. (WIPO Publication 2019/136164) in view of Locke et al. (U.S. Publication 2015/0320602), Greener (U.S. Publication 2020/0107965), and Simmons et al. (U.S. Publication 2019/0307935), and further in view of Jacobs et al. (U.S. Publication 2009/0286895).
Regarding claim 19, Carroll in view of Locke and further in view of Greener and Simmons suggest the dressing of claim 1. Carroll in view of Locke do not expressly disclose the manifold layer comprising an expanded foam material, and wherein the expanded foam material is formed by a process comprising: impregnating a polymeric material with an inert gas at high heat and pressure to form an impregnated polymeric material; and expanding the impregnated polymeric material to form the expanded foam material.
The claimed phrase “wherein the expanded foam material is formed by a process comprising: impregnating a polymeric material with an inert gas at high heat and pressure to form an impregnated polymeric material; and expanding the impregnated polymeric material to form the expanded foam material” is being treated as a product by process limitation as a material that results from the process of impregnating a polymeric material and expanding it. As set forth in MPEP 2113, “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 in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes that the applicant has attributed the structure of a closed cell foam from the impregnation and expansion process in ¶0076 and as such this limitation is being given very little patentable weight outside of the structure of the foam product being a closed cell foam impregnated with an inert gas as detailed by the applicant.
While Carroll in view of Locke do not expressly disclose or suggest the foam being a closed-cell foam, Locke, in the same field of endeavor of dressings for treating a tissue site with negative pressure (Abstract), teaches the contracting layer being a closed-cell Zotefoam ¶0054.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the foam material of Carroll that performs the function of providing a foam layer in which apertures may be positioned and is compressible for the Zotefoam of Locke since these elements perform the same function of providing a compressible foam layer into which apertures can be applied. Simply substituting one foam layer for another would yield the predictable result of allowing a(n) layer to be compressible and include structured apertures within. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make foam layer of Carroll out of closed cell Zotefoam, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Locke does not expressly suggest how this closed-cell Zotefoam is formed and thus does not disclose whether an inert gas is impregnated within the foam.
However, Jacobs et al., as assigned to Zotefoams PLC, in the same field of endeavor of closed-cell foams teaches forming a closed-cell Zotefoam by subjecting a polymer (Abstract, silicone base) to an inert gas at an elevated pressure, and reducing the pressure to allow the base to expand and produce closed cell silicone foam (Abstract) which would inherently have impregnated inert gas as the impregnated gas is what leads to the expansion.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a closed-cell foam impregnated with an inert gas as taught by Jacobs since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416 as detailed in the substitution above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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