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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/09/2026 has been entered.
Status of Claims
Claims 1-17, 19-20, 24, 32-34, 40, 42-43, 47-48, 63, and 72 are currently pending. Claims 18, 21-23, 25-31, 35-39, 41, 44-46, 49-62, 64-71, and 73-80 were previously cancelled. No claims have been amended. No new subject matter added.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
In regards to the term “ovoidal” its interpretation is dependent on Merriam Webster’s definition of ovoid shape “resembling an egg in shape”. This would include terms such as oval oblong, and rounded.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-17, 19-20, 24, 32-34, 40, 42-43, 47-48, 63, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons (US 20190307935 A1), hereinafter referred to as “Simmons” in view of Shen et al. (WO 2017063036 A1), hereinafter referred to as “Shen” .
Regarding claim 1, Simmons teaches a foam manifold pad (compression layer (46) can be an open cell foam, see Paragraph [0054]; Figure 1) (compression layer (46) is formed from the compression layer material, as shown in Figures 22A-23B; Paragraph [0126]) comprising:
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a first surface (as shown below);
a second surface (as shown above); and
a thickness of foam extending between the first surface and the second surface (the foam extending through the first and second surfaces, see Figure 23B);
wherein: the foam of the manifold pad is formed of a single foam block (compressive layer 46 is a single foam layer, see Figures 1 and 22A; Paragraph [0127]; embodiments may be used together, see Paragraph [0138]) comprising a plurality of ovoidal pores (having a plurality of ovoidal pores (1092), see Figure 23A-B) each comprise a major axis (longitudinal axis (1084), see Figure 23B) and a minor axis (lateral axis (1080), see Figure 23B), a length along the major axis is longer than a length along the minor axis (length along the longitudinal axis is longer than lateral axis, see Figure 23B); and
the manifold pad is configured to contract radially or laterally and to resist contraction in the thickness (compressive material (1072) is anisotropic contract in one direction, i.e. a laterally, see Paragraph [0057] and [0128]) upon application of negative pressure (compression layer is configured to contract with application of negative pressure, see Paragraph [0056]).
However, Simmons does not explicitly disclose wherein the major axis is oriented perpendicular to the first surface.
Shen teaches a wound filler (100) used for negative pressure wound therapy of a wound (see Abstract) comprising: a block of porous wound fill material (102) having a specific matrix of vertical apertures or voids (110) which extend through the porous wound fill material between the upper side (106) and the lower side (108) thereof (see Paragraph [081]; Figure 2B).
Simmons and Shen are analogous art because both disclose a porous wound fill material having apertures.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pores of Simmons and have them be positioned vertically across the thickness of the material layer wherein the major axis is perpendicular to the first surface and the minor axis parallel to the first surface, as taught by Shen. Shen teaches the wound filler is configured to provide selective stiffness and deformation. Improved wound closure can be obtained by limiting vertical deformation of the wound filler and enhancing the horizontal collapse of the wound filler using apertures (see Paragraph [034]).
Regarding claim 2, Simmons and Shen teaches all of the limitations of claim 1 and Simmons further teaches wherein the ovoidal pores (1092) are configured to contract in a direction parallel to the first surface (contracting along the minor axis, i.e. lateral direction, parallel to the first surface, see Figure 23B) upon application of negative pressure to the manifold pad compression layer is configured to contract with application of negative pressure, see Paragraph [0056]).
Regarding claim 3, Simmons and Shen teaches all of the limitations of claim 1 and Simmons further teaches wherein the manifold pad (1072) is configured to be free of contraction in a direction of the thickness extending from the first surface to the second surface under negative pressure (the compressive layer is anisotropic meaning 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 when subjected to negative pressure, see Paragraph [0057]) (therefore contraction in the thickness or vertical direction is minimal in comparison to the lateral direction).
Regarding claim 4, Simmons and Shen teaches all of the limitations of claim 1 and Simmons further teaches wherein the manifold pad (1072) is configured to contract more radially or laterally than in thickness under applied negative pressure (anisotropic compressive layer (1072) can contract more laterally than vertically or in thickness see Paragraph [0057] and [0128]).
Regarding claim 5, Simmons and Shen teaches all of the limitations of claim 1 and Simmons further teaches wherein: the minor axis is oriented parallel to the first surface (lateral axis (1080) is parallel to the first surface, see Figure 23B), and for each ovoidal pore (see Figure 23B), the major axis is perpendicular to the minor axis (see Figure 23B).
Regarding claim 6, Simmons and Shen teaches all of the limitations discussed in claim 5 and Simmons further teaches wherein the ovoidal pores (1092) are configured so that, upon application of negative pressure (see Paragraph [0057]), the ovoidal pores contract more in the direction of the minor axis than in the direction of the major axis (compression is configured to be in the minor axis of the pores, see Paragraph [0057] and [0128]).
Regarding claim 7, Simmons and Shen teaches all of the limitations of claim 1 and Simmons further teaches wherein the foam comprises open-cell foam (compression layer (46)/(1072) can be an open cell foam, see Paragraph [0054]).
Regarding claim 8, Simmons and Shen teaches all of the limitations discussed in claim 5 and Simmons further teaches further teaches wherein the foam (1072) comprises felted foam (see Paragraph [0057]) with an axis of compression (minor axis is parallel to the axis of compression, see Paragraph [0057] and [0128]) (see Paragraph [081] of Shen), and the minor axis of the ovoidal pores is parallel to the axis of compression (see Paragraph [081] of Shen).
Regarding claim 9, Simmons and Shen teaches all of the limitations discussed in claim 8 and Simmons further teaches further teaches wherein the felted foam comprises a firmness factor of 2-7 (the compressive layer can be made of the reticulated polyurethane foam (e.g., Granufoam®) material that has been felted to a firmness of 5, see Paragraph [0076]) (embodiments may be used together, see Paragraph [0138]).
Regarding claim 10, Simmons and Shen teaches all of the limitations discussed in claim 9 and Simmons further teaches further teaches wherein a ratio of a contraction of the minor axis of the ovoidal pores relative to a contraction of the major axis of the ovoidal pores, under applied negative pressure, is greater than 1 (it is to be understood that the compressive layer material is anisotropic allowing for greater contraction in the minor axis vs the major axis on a scale that is larger than 1, see Paragraph [0057] and [0128]).
Regarding claim 11, Simmons teaches a dressing for treating a tissue site (a wound dressing, see Abstract) (see Figures 1 and 23B), comprising:
a treatment device (wound therapy device (10), see Figure 1) having a film layer (visceral protective layer (42) is polyurethane film, see Paragraph [0050]) (see Figure 1) and configured to channel fluid radially under
applied negative pressure (the wound therapy system (10) can be used with a negative pressure wound therapy (NPWT) system (54), see Paragraph [0048]); and
an open-cell foam manifold pad (compression layer (46) can be an open cell, see Paragraph [0054]) (compression layer (46) is formed from the compression layer material, as shown in Figures 22A-23B; Paragraph [0126]) comprising:
a first surface (as shown above in Figure 23A-B);
a second surface (as a shown above in Figure 23A-B); and
a thickness of open-cell foam extending between the first surface and the second surface (the foam extending through the first and second surfaces, see Figure 1 and 23B);
wherein: the open-cell foam of the manifold pad is formed of a single foam block (compressive layer 46 can be formed from a single foam layer, see Figures 1 and 22A; Paragraph [0127]; embodiments may be used together, see Paragraph [0138]) comprising a plurality of ovoidal pores (plurality of ovoidal pores (1092), see Figure 23B) each including a minor axis (lateral axis (1080), see Figure 23B) and a major axis (longitudinal axis (1084), see Figure 23B), wherein for each ovoidal pore, a length along the major axis is longer than a length along the minor axis (length along the longitudinal axis is longer than lateral axis, see Figure 23B);
the manifold pad is configured to contract in a plane parallel to the first surface (compressive material (1072) is anisotropic contract in one direction, i.e. a direction parallel to the first surface, see Paragraph [0057] and [0128]) upon application of negative pressure (compression layer is configured to contract with application of negative pressure, see Paragraph [0056]); and
the manifold pad (1072) is configured to contract less in thickness than radially or laterally under applied negative pressure (an anisotropic compressive layer material configured to collapse in a lateral direction more than a vertical and/or a longitudinal direction, see Paragraph [0128]).
However, Simmons does not explicitly disclose wherein the major axis is oriented perpendicular to the first surface.
Shen teaches a wound filler (100) used for negative pressure wound therapy of a wound (see Abstract) comprising: a block of porous wound fill material (102) having a specific matrix of vertical apertures or voids (110) which extend through the porous wound fill material between the upper side (106) and the lower side (108) thereof (see Paragraph [081]; Figure 2B).
Simmons and Shen are analogous art because both disclose a porous wound fill material having apertures.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pores of Simmons and have them be positioned vertically across the thickness of the material layer wherein the major axis is perpendicular to the first surface and the minor axis parallel to the first surface, as taught by Shen. Shen teaches the wound filler is configured to provide selective stiffness and deformation. Improved wound closure can be obtained by limiting vertical deformation of the wound filler and enhancing the horizontal collapse of the wound filler using apertures (see Paragraph [034]).
Regarding claim 12, Simmons and Shen teaches all of the limitations of claim 11 and Simmons further teaches a sealing member (sealing layer (50), see Figure 1) configured to cover the manifold pad and the treatment device (configured to cover the compressive layer (46) of wound dressing (10), see Figure 1) and to provide a pneumatic seal relative to the tissue site (sealing layer (50) creates a seal spaced between the sealing layer and skin, see Paragraph [0043]).
Regarding claim 13, Simmons teaches all of the limitations of claim 11 and further teaches wherein:
the minor axis is oriented parallel to the first surface (lateral axis (1080) is parallel to the first surface, see Figure 23B);
for each ovoidal pore, the major axis is perpendicular to the minor axis (see Figure 23B); and
the ovoidal pores are configured so that, upon application of negative pressure, the ovoidal pores contract more in the direction of the minor axis than in the direction of the major axis (see Paragraph [0128]).
Regarding claim 14, Simmons and Shen teaches all of the limitations discussed in claim 13 and Simmons further teaches wherein:
the foam comprises felted foam (compressive layer is a felted foam material, see Paragraph [0057]) with an axis of compression (axis of compression is parallel to the lateral axis, see Paragraph [0128]);
the minor axis (1080) of the ovoidal pores is parallel to the axis of compression (see Paragraph [0128]) (see Paragraph [081] of Shen); and
the felted foam comprises a firmness factor of 2-7 (the compressive layer can be made of the reticulated polyurethane foam (e.g., Granufoam®) material that has been felted to a firmness of 5, see Paragraph [0076]) (embodiments may be used together, see Paragraph [0138]).
Regarding claim 15, Simmons teaches a method for forming a dressing (forming the dressing of Figure 1 and 22-23), comprising:
providing a blank of foam (compression layer (46) can be an open cell foam, see Paragraph [0054]) (compression layer (46) is formed from the compression layer material, as shown in Figures 22A-23B; Paragraph [0126]) formed as a single foam block (compressive layer 46 is a single foam layer, see Figures 1 and 22A; Paragraph [0127]) having a plurality of pores (having a plurality of ovoidal pores (1092), see Figure 23B);
altering the foam blank to form foam (see Claim 22 of Simmons), wherein altered pores of the foam each are ovoidal with a major axis (vertical axis (1084)) and a minor axis (lateral axis (1080), see Figure 23B); and
shaping the foam to form a manifold pad (compressive layer (1072), see Figure 23B) formed from the single foam block and having a first surface (see in Figures 1, 22A-23B above), a second surface (see in Figure 23A-B above), and a thickness of foam extending between the first surface and the second surface (thickness of foam layer (1072) extending between the surfaces, see Figure 1 and 23B), wherein the minor axis (1080) is parallel to the first surface (parallel to the first surface, see Figure 23B).
wherein shaping the foam comprises cutting the foam to form the first surface parallel to the minor axis (first surface is parallel to the minor axis (1080), see Figure 23B).
However, Simmons does not explicitly disclose wherein the major axis is oriented perpendicular to the first surface.
Shen teaches a wound filler (100) used for negative pressure wound therapy of a wound (see Abstract) comprising: a block of porous wound fill material (102) having a specific matrix of vertical apertures or voids (110) which extend through the porous wound fill material between the upper side (106) and the lower side (108) thereof (see Paragraph [081]; Figure 2B).
Simmons and Shen are analogous art because both disclose a porous wound fill material having apertures.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pores of Simmons and have them be positioned vertically across the thickness of the material layer wherein the major axis is perpendicular to the first surface and the minor axis parallel to the first surface, as taught by Shen. Shen teaches the wound filler is configured to provide selective stiffness and deformation. Improved wound closure can be obtained by limiting vertical deformation of the wound filler and enhancing the horizontal collapse of the wound filler using apertures (see Paragraph [034]).
Regarding claim 16, Simmons and Shen teaches all of the limitations discussed in claim 15 and Simmons further teaches wherein altering the foam blank comprises compressing the foam blank along an axis of compression to permanently deform the plurality of pores to form the foam with ovoidal pores (felting process for generating an anisotropic compressive layer material, such as the felted foam, see Paragraph [0127]) (the permanent compression causes the pores to deform such that the pores compress in the generally vertical direction and elongate in at least the lateral direction as shown, see Paragraph [0127]) (see Figures 22-23) and the minor axis parallel to the axis of compression (axis of compression is parallel to the lateral axis (1080), see Paragraph [0128]). Shen further teaches wherein the major axis is oriented perpendicular to the first surface (a block of porous wound fill material 102 having a specific matrix of vertical apertures or voids 110 which extend through the porous wound fill material between the upper side 106 and the lower side 108 thereof, see Paragraph [081]; Figure 2B).
Regarding claim 17, Simmons and Shen teaches all of the limitations discussed in claim 16 and Simmons further teaches wherein shaping the foam comprises cutting the foam perpendicular to the axis of compression (compressive layer (1104) then cut out of the compressive layer material (1071), see Paragraph [0128]) (see Figure 23B).
Regarding claim 19, Simmons and Shen teaches all of the limitations of claim 16 and Simmons further teaches wherein shaping the foam comprises rotating the foam 90 degrees after compression (strips (1096) of compressive layer (1072) can have a width that is at least a width of the compressive layer (1104), the strips are then rotated (90) degrees to orient the strips (1096) as shown in FIG. 23b), and then cutting the foam through the thickness (see Paragraph [0128]).
Regarding claim 20, Simmons and Shen teaches all of the limitations discussed in claim 15 and Simmons further teaches wherein altering the foam blank comprises felting the foam blank to a firmness factor of 2-7 along an axis of compression the compressive layer can be made of the reticulated polyurethane foam (e.g., Granufoam®) material that has been felted to a firmness of 5, see Paragraph [0076]) (embodiments may be used together, see Paragraph [0138]) (compressing the foam along the lateral axis (1080), see Paragraph [0057]) so that the foam is formed with ovoidal pores (1092) and the minor axis parallel to the axis of compression (minor axis (1080) parallel to the compression axis, see Paragraph [0057] and [0128]). Shen further teaches wherein the major axis is oriented perpendicular to the first surface (a block of porous wound fill material 102 having a specific matrix of vertical apertures or voids 110 which extend through the porous wound fill material between the upper side 106 and the lower side 108 thereof, see Paragraph [081]; Figure 2B).
Regarding claim 24, Simmons and Shen teaches all of the limitations of claim 1 and Simmons further teaches wherein the foam (1072) is configured to be more resistant to contraction of thickness than contraction in a plane parallel to the first surface (anisotropic compression layer (1072) can be more resistance to contraction in the thickness of the foam layer, see Paragraph [0057] and [0128]).
Regarding claim 32, Simmons and Shen teaches all of the limitations discussed in claim 5 and Simmons further teaches wherein the ovoidal pores (1092) are configured to be more resistant to contraction along the major axis than contraction along the minor axis (anisotropic compressive layer (1072), see Paragraph [0057] and [0128]).
Regarding claim 33, Simmons and Shen teaches all of the limitations discussed in claim 5 and Simmons further teaches wherein the ovoidal pores (1092) are configured to contract more along the minor axis than along the major axis, upon application of negative pressure (anisotropic compressive layer (1072) contracts more along the minor axis than the major axis, see Paragraph [0057] and [0128]).
Regarding claim 34, Simmons and Shen teaches all of the limitations discussed in claim 8 and Simmons further teaches wherein the felted foam comprises a firmness factor of 3-5 (the compressive layer can be made of the reticulated polyurethane foam (e.g., Granufoam®) material that has been felted to a firmness of 5, see Paragraph [0076]).
Regarding claim 40, Simmons and Shen teaches all of the limitations discussed in claim 9 and Simmons further teaches wherein the felted foam is formed from a foam blank having a density of 1.3-1.6 lb/ft3 (density of the compressive layer material, e.g., Granufoam® material, is typically in the range of about 1.3-1.6 lb/ft3, see paragraph [0055]), a free volume of 90% or more (it is to be understood with the free volume of the compressive layer in Simmons would be 90% or more based on the material, Granufoam® material, and felting process), an average number of pores per inch of 40-50, an average pore size of 400-600 micron (the reticulated pores of the Granufoam® material generally range in size between about 400 to 600 microns, see Paragraph [0055]), a 25% compression load deflection of at least 0.35 pounds per square inch (he compressive layer material can have a minimum 25% load deflection of approximately 0.35 pounds per square inch, see Paragraph [0058]), and a 65% compression load deflection of at least 0.43 pounds per square inch (the compressive layer material can have a minimum 65% compression load deflection of approximately 0.43 pounds per square inch).
Regarding claim 42, Simmons and Shen teaches all of the limitations discussed in claim 1 and Simmons further teaches wherein the first surface is configured to face outward, away from the tissue site (first surface can be facing away from the patient, see Figure 1 and 23B), and the second surface is configured to face towards the tissue site (second surface can be the wound facing surface, see Figure 1 and 23B).
Regarding claim 43, Simmons and Shen teaches all of the limitations discussed in claim 13 and Simmons further teaches a sealing member (sealing layer (50), see Figure 1) configured to cover the manifold pad and the treatment device (configured to cover the compressive layer (46) of wound dressing (10), see Figure 1) and to provide a pneumatic seal relative to the tissue site (sealing layer (50) creates a seal spaced between the sealing layer and skin, see Paragraph [0043]), wherein each of the ovoidal pores (1092) is oriented with the minor axis (oriented along the lateral axis (1080), see Figure 23B) parallel to a portion of the sealing member over the manifold pad (parallel to the first surface and the sealing member, see Figure 1 and 23B), and wherein each of the ovoidal pores (1092) is oriented with the minor axis (1080) parallel to a portion of the treatment device underlying the manifold pad (lateral axis is parallel to the wound dressing (10), see Figure 1 and 23B).
Regarding claim 47, Simmons and Shen teach all of the limitations discussed in claim 11 and Simmons further teaches wherein the treatment device (10) further comprises a central fluid hub (hub housing a NPWT port (1004) and an instillation port (1008), see Figure 1) and a plurality of elongate members extending outward from the central fluid hub (tubing of ports (1004) and (1008), see Figure 1) , wherein each elongate member is in fluid communication with the central fluid hub (to fluidly communicate for establishing fluid communication with the NPWT system (54) and an instillation system (58), see Paragraph [0119]).
Regarding claim 48, Simmons and Shen teaches all of the limitations discussed in claim 47 and Simmons further teaches wherein the manifold pad (compressive layer (1072)) is configured to be positioned proximate to and/or contacting the central fluid hub (compressive layer (46 or 1072) is configured to be contacting the fluid hub, see Figure 1).
Regarding claim 63, Simmons and Shen teaches all of the limitations discussed in claim 5 and Simmons further teaches wherein the ovoidal pores (1092) are configured to contract more in a plane perpendicular to the thickness of the manifold pad than in a plane parallel to the thickness of the manifold pad (the pores (1092) are contracting along a minor axis which is perpendicular to the thickness of the manifold, see Paragraph [0128]), upon application of negative pressure (see Abstract).
Regarding claim 72, Simmons teaches a manifold pad (compression layer (46) can be an open cell foam, see Paragraph [0054]; Figure 1) (compression layer (46) is formed from the compression layer material, as shown in Figures 22A-23B; Paragraph [0126]), comprising:
a first surface (as shown above in Figure 23A-B);
a second surface (as shown above in Figure 23A-B); and
a thickness of foam extending between the first surface and the second surface (the foam extending through the first and second surfaces, see Figure 23B); wherein:
the foam of the manifold pad is formed of a single foam block (compressive layer 46 can be formed from a single foam layer, see Figures 1 and 22A; Paragraph [0127]; embodiments may be used together, see Paragraph [0138]) comprising a cell-structure having a plurality of ovoidal cells (having a plurality of ovoidal pores (1092), see Figure 23B); each of the ovoidal cells comprises a major axis and a minor axis; and
the minor axis of the ovoidal cells is oriented perpendicular to the thickness of the manifold pad (the minor axis (1080) is perpendicular to the thickness of the compressive layer (1072), see Figures 23A-B); and the ovoidal cells are configured to preferentially contract along the minor axis (the pores (1092) are configured to contract along the minor axis (1080), see paragraph [0057] and [0128]), as opposed to the major axis (anisotropic compressive material is configured to contract more in one direction, see Paragraph [0057] and [0128]), upon application of negative pressure (see Abstract).
However, Simmons does not explicitly disclose wherein the major axis is oriented perpendicular to the first surface.
Shen teaches a wound filler (100) used for negative pressure wound therapy of a wound (see Abstract) comprising: a block of porous wound fill material (102) having a specific matrix of vertical apertures or voids (110) which extend through the porous wound fill material between the upper side (106) and the lower side (108) thereof (see Paragraph [081]; Figure 2B).
Simmons and Shen are analogous art because both disclose a porous wound fill material having apertures.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pores of Simmons and have them be positioned vertically across the thickness of the material layer wherein the major axis is perpendicular to the first surface and the minor axis parallel to the first surface, as taught by Shen. Shen teaches the wound filler is configured to provide selective stiffness and deformation. Improved wound closure can be obtained by limiting vertical deformation of the wound filler and enhancing the horizontal collapse of the wound filler using apertures (see Paragraph [034]).
Response to Arguments
Applicant's arguments filed 07/18/2025 have been fully considered but they are not persuasive.
Specifically, Applicant argue in Claims 1, 11, 15, and 72 that it is improper for the office to allege that Simmons embodiments may be used together and that there is difference of the pores formed in the plurality of strips in Figure 23A-B compared to the pores in the single layer foam material shown in Figure 1. The applicant further argues that Simmons does not teach how to obtain the configuration of elongated pores in Figure 23 without the compressive layer being cut into a plurality of strips.
The examiner respectfully disagrees with the applicant that the embodiments of Simmons cannot be used together. Paragraph [0138] of Simmons discloses “although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied.” Therefore, the configuration of elongated pores shown in Figure 23 would be reasonable to be placed onto a single foam layer as shown in Figure 22, regardless of how the orientation was achieved.
Specifically, Applicant argue in Claims 1, 11, 15, and 72 that the aperture/voids 110 in Shen’s Figure 2B cannot be reasonably compared to the pores of Claim 1 based at least on the ordinary meanings and the meanings that a person skilled on the art would understand. The applicant states that Shen teaches the aperture/voids 110 are clearly a distinguishable feature from the pores of the porous wound fill material 102 through which the aperture/voids 110 are disposed. Therefore, Shen aperture/voids 110 cannot be interpreted as “pores”.
The examiner respectfully disagrees with the applicant that the aperture/voids 110 of Shen cannot be interpreted as “pores” as described in claim 1. It would be reasonable to interpret the apertures in Shen to be analogous to the apertures in Simmons because they are in plain meaning, an opening in the foam layer that serves the same function of assisting in horizontal or lateral compression of the wound filler. The shape and orientation of the apertures in Shen can be positioned in wound filler material between the stiffener elements in any suitable configuration which assist horizontal and lateral compression of the wound filler, see Paragraph [027]. Paragraph [028]-[031] further discusses different configurations of the apertures vertically through the wound fill material. Therefore, Simmons in view of Shen would read on the limitations of Claims 1, 11, 15, and 72.
Specifically, Applicant argue in Claims 1, 11, 15, and 72 that the aperture/voids 110 in Shen’s Figure 2B do not teach anything regarding the pores having a specific shape and orientation. The applicant further argues there is improper hindsight to modify the apertures in Shen to modify the orientation of Simmons pores.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, Paragraph [0035] discloses the porous wound fill material containing regular specific matrix vertical apertures designed to counteract the negative effect of stiffener elements on the closure ratio of the wound filler. Therefore, Simmons does teach a specific shape/orientation of the aperture for the benefit of assisting in counteracting the negative effect of stiffener elements on the wound filler. Therefore, Simmons in view of Shen would read on the limitations of Claims 1, 11, 15, and 72.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas J. Weiss can be reached on (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC RASSAVONG/ (4/15/2026)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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