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 Status
The amendment submitted on February 19th, 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, 6, and 9 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 Claims 27-29, 33-35, 41-42, 47-50, and 52-55 have been withdrawn from consideration according to the above restriction as being drawn toward an unelected group.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 February 19th, 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 Greener (U.S. Publication 2020/0107965), 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).
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).
PNG
media_image1.png
676
484
media_image1.png
Greyscale
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, or a perpendicular bisector extending through a midpoint of a length of one of the first portion of collapsible apertures being oriented through a midpoint of a width of at least one of the second portion of collapsible apertures.
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 extending through a midpoint of a length of one of the first portion of collapsible apertures being 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 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 (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).
PNG
media_image2.png
298
529
media_image2.png
Greyscale
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 claim 2, Carroll in view of Locke and further in view of Greener 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 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 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 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 suggest the dressing of claim 1. Carroll in view of Locke do not expressly disclose or suggest the manifold layer further comprising a plurality of fluid apertures extending through the thickness of the manifold between the first surface and the second surface, wherein the fluid apertures are configured to exhibit less deformation in response to the negative pressure applied to the manifold layer relative to the plurality of collapsible apertures.
However, Locke, in the same field of endeavor of dressings for treating a tissue site with negative pressure (Abstract), teaches a contracting layer 514 including stripes having a first density 516 and stripes having a second density 518, wherein these stripes are oriented vertically relative to a tissue site (¶0093) wherein the second density is greater than the first density for the purpose of providing regions of the contracting layer that collapse prior to other regions (¶0093 stripes may collapse before the stripes 518) directing the compression of the contracting layer in a particular direction (contracting layer may compress perpendicular to the stripes 516).
It would have been obvious to one of ordinary skill in the art to have modified the manifold layer of Carroll in view of Locke to have included regions within the foam body with different densities as taught by Locke for the purpose of providing regions of the contracting layer that collapse prior to other regions (¶0093 stripes may collapse before the stripes 518) directing the compression of the contracting layer in a particular direction (contracting layer may compress perpendicular to the stripes 516). As the density of the foam provides the structure for the apertures placed within, providing different regions of density across the manifold layer would inherently result in apertures that exhibit less deformation in response to the negative pressure applied.
Regarding claim 14, Carroll in view of Locke and further in view of Greener 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 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 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 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 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), 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 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 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 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781