DETAILED ACTION
In Applicant’s Response filed 12/15/25, Applicant has amended claims 1-2, 4-5, 12, 16 and 18-19; added new claims 21-24; amended the specification; and submitted a new drawing sheet with a new figure 5. Claims 3, 11, 14 and 20 have been cancelled. Currently, claims 1-2, 4-10, 12-13, 15-19 and 21-24 are pending.
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 .
Drawings
The drawings were received on 12/15/25. These drawings are acceptable.
Claim Objections
Claims 2, 4-5, 12, 18 and 19 are objected to because of the following informalities: the claims have been provided with an incorrect status identifier because each of the claims recites that it is “currently amended” but it fails to include any underlining or other markings to the text which would indicate that changes are being made by amendment. Correction of the status identifier in future communications is necessary in order to clarify of the status of the claims. Appropriate correction is required.
Claims 1-2, 4-5, 12, 18 and 19 are objected to as failing to comply with 37 CFR 1.121 because each of these claims fails to include markings to identify changes which have been made to the claim. For example, the following changes appear to have been made to the claims but do not include strikethrough, underlining, or other markings to identify changes that are being made:
In claim 1 line 5: “said skin adhesion layer” appears to have been changed to “said rim adhesion layer”.
In claim 1 line 9: “disposed a” appears to have been changed to “disposed on a”.
In claim 2 line 1: “said rim” appears to have been changed to “said protective rim”.
In claim 2 line 2: “said rim” appears to have been changed to “said protective rim”.
In claim 4 line 3: "said window" appears to have been changed to “a window”.
In claim 5 line 1: “said rim” appears to have been changed to “said protective rim”.
In claim 12 line 5 “fixed a” appears to have been changed to “fixed to a”.
In claim 18 line 1: “said rim” appears to have been changed to “said protective rim”.
In claim 18 line 2: “said rim” appears to have been changed to “said protective rim”.
In claim 19 line 1: “said rim” appears to have been changed to “said protective rim”.
This is not a complete listing of all instances where there is no striking through of the language which has been removed or underlining of the language which has been added but merely examples of the types of issues present with the pending claims. Under MPEP §714(II)(C)(B), “claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter) with 2 exceptions: (1) for deletion of five or fewer consecutive characters, double brackets may be used (e.g., [[eroor]]); (2) if strike-through cannot be easily perceived (e.g., deletion of number “4” or certain punctuation marks), double brackets must be used (e.g., [[4]])”. Therefore, currently amended claims 1-2, 4-5, 12, 18 and 19 do not comply with 37 CFR 1.121. It has been assumed for examination purposes that Applicant intended for the claims to include the language which is currently present in the claims, but revision is nevertheless required (i.e. proper strikethrough and/or underlining of deleted/added terms).
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.
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.
Claim(s) 1-2, 4, 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over LaGreca (US 2016/0374863) in view of Lavender et al (US 5562107).
With respect to claim 1, LaGreca discloses a mobile wound cover (dressing system 10 which comprises a reclosable dressing – para [0025]; the reclosable dressing is interpreted as being mobile to permit opening and closing multiple times), comprising: a skin adhesion rim (base member 20 comprised of annulus 22) having a skin adhesion layer (adhesive on lower side – para [0026]) and an oppositely disposed rim adhesion layer (upper surface of annulus 22 that faces and is configured to attach to layer 24 as shown in fig 1), said skin adhesion rim having a first aperture therein (base member 20 is an annulus or other shape that defines or encompasses an open area at the center for accommodating a wound W – see para [0026] and fig 1-2); a protective rim (top layer 24), having a skin surface (lower surface of layer 24 which is the surface that faces and is configured to attach to base member 20 in fig 1) and a cover surface (upper surface of layer 24 which is the surface that faces and is configured to attach to member 30 in fig 1), said skin surface (lower surface of layer 24) arranged to secure to said rim adhesion layer (upper surface of annulus 22) of said skin adhesion rim (annulus 22 of base 20) (layer 24 is adhered to the top of annulus 22 – para [0026]), said protective rim (24) having a second aperture therein (has same size and shape as annulus 22 – para [0026]; thus, layer 24 is an annulus or other shape that defines or encompasses an open area at the center for accommodating a wound W like annulus 22 of base 20 – see para [0026] and fig 1-2); and, a cover (cover/top member 30 comprising a sheet 34; fig 1), said cover (30) arranged to removably engage said cover surface of said protective rim (upper surface of layer 24)(member 30 is removably adhered to the top of base member 20 via attachment between annulus 32 and layer 24 – see para [0026-0029] and figs 1-2), said cover (30) further including a removable securement means (annulus 32) arranged to removably secure said cover to said cover surface of said protective rim (para [0029]), said securement means (32) disposed a distal surface of said cover (as shown in fig 1), said cover (30) being at least semi-transparent (sheet 34 of top member 30 is preferably translucent or clear – para [0030]). LaGreca also discloses that said securement means comprises: an adhesive secured to said distal surface of said cover (annulus 32 comprises polyurethane medical grade adhesive tape – para [0029]), said cover (34) comprising a transparent film (para [0029-0030]), wherein said adhesive is adapted to releasably adhere to said rim (para [0034]).
LaGreca does not, however, disclose that said securement means comprises: a single-sided adhesive secured to said cover surface of said rim, said single-sided adhesive comprising an adhesive surface adhered to said cover surface of said rim and an oppositely disposed blocker surface; and, a double-sided adhesive secured to said distal surface of said cover and adapted to releasably adhere to said blocker surface of said single-sided adhesive.
Lavender teaches a similar wound cover which comprises a single-sided adhesive secured to said cover surface of said rim (barrier 13 which is composed of adhesive – col 3 lines 62-63), said single-sided adhesive comprising an adhesive surface adhered to said cover surface of said rim and an oppositely disposed blocker surface (one side has exposed adhesive when release sheet 15 is removed while the opposite surface includes a backing 14 as shown in fig 2); and, a double-sided adhesive (double-sided adhesive tape 21) secured to said distal surface of said cover (secured to the distal surface of cover film 19 as shown in fig 2) and adapted to releasably adhere to said blocker surface of said single-sided adhesive (the double sided adhesive on cover 19 permits releasable attachment to backing 14 of base 11; see col 5 line 54 – col 6 line 25). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of LaGreca so that the securement means comprises a single-sided adhesive secured to said cover surface of said rim, said single-sided adhesive comprising an adhesive surface adhered to said cover surface of said rim and an oppositely disposed blocker surface; and, a double-sided adhesive secured to said distal surface of said cover and adapted to releasably adhere to said blocker surface of said single-sided adhesive, as taught by Lavender, in order to permit repeated opening and resealing of the cover against the base (see Lavender col 6 lines 12-25).
With respect to claim 2, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 1) and LaGreca also discloses that said rim (24) is arranged to create a vertical distance between said skin adhesion rim and said cover (as shown in fig 1, the layer 24 has a thickness which inherently creates spacing between annulus 22 of base 20 and sheet 34 of cover 30).
LaGreca does not, however, explicitly disclose that the rim may be comprised of a hydrophilic material.
Lavender teaches a similar wound cover which comprises a protective rim (base 11 which includes backing layer 14) wherein the backing layer is preferably composed from a polyetherimide film (col 4 lines 40-42) wherein polyetherimides are known to be capable of being modified to have either hydrophilic or hydrophobic characteristics. Lavender also teaches that the layer 14 should be formed from a material that is moisture vapor permeable (col 4 lines 28-30). Thus, the polyetherimide film used for backing layer 14 is interpreted as being at least partly hydrophilic so as to be capable of transmitting moisture vapor rather than repelling moisture and liquids. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the rim of LaGreca from a hydrophilic material, such as a polyetherimide as taught by Lavender, in order to permit moisture vapor transmission through the material to prevent moisture from accumulating at a wound site which could cause infection.
With respect to claim 4, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 3) and Lavender further teaches that said double-sided adhesive (21) is arranged proximate an external edge of said cover (formed as an adhesive border 20 that extends along the perimeter 19a of cover 19 – col 5 lines 24-35) thereby forming a non-adhesive section on said distal surface of said cover, said non-adhesive section defining a window (the adhesive border 20 forms a frame which surrounds a central transparent viewing area 19b – col 5 lines 27-29). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of LaGreca in view of Lavender so that said double-sided adhesive is arranged proximate an external edge of said cover thereby forming a non-adhesive section on said distal surface of said cover, said non-adhesive section defining a window, as taught by Lavender, to permit viewing of a wound without requiring removal of the dressing.
With respect to claim 8, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 4) and Lavender further teaches a blocker releasably secured to a portion of a distal surface of said double-sided adhesive of said distal surface of said cover (release sheet 22 – col 5 lines 54-60; fig 2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of LaGreca in view of Lavender to include a blocker releasably secured to a portion of a distal surface of said double-sided adhesive of said distal surface of said cover as taught by Lavender in order to protect the adhesive prior to use.
With respect to claim 9, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 1) and LaGreca also discloses that said first aperture and second aperture are substantially colinear (as shown in fig 1).
With respect to claim 12, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 3) and Lavender further teaches that said double-sided adhesive (21) comprises: a first adhesive (21a); a second adhesive (21a); and, a carrier having said first adhesive fixed a first surface thereof and said second adhesive fixed to a second surface thereof (substrate 21b interposed between the adhesive layers – col 5 lines 34-36). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of LaGreca in view of Lavender so that the double-sided adhesive comprises: a first adhesive; a second adhesive; and, a carrier having said first adhesive fixed a first surface thereof and said second adhesive fixed to a second surface thereof as taught by Lavender in order to provide a structure capable of adhesion on both sides.
Claim(s) 5-7, 16, 18-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over LaGreca (US 2016/0374863) in view of Lavender et al (US 5562107) and further in view of Aali (US 2006/0235347).
With respect to claim 5, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 2) but does not disclose that said rim is comprised of a foam.
Aali, however, teaches a wound protecting device wherein the rim is formed from a deformable member that is made of polyurethane foam is used for its ability to absorb exudate (para [0014]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the rim on the device of LaGreca in view of Lavender from foam, like the deformable member of Aali, in order to allow for exudate absorption.
With respect to claim 6, LaGreca discloses the wound cover as claimed (see rejection of claim 1) but does not disclose that said skin adhesion rim comprises a double-sided adhesive, said skin adhesion layer comprising a first adhesive and said rim adhesion layer comprising a second adhesive, said first and second adhesives arranged on opposite sides of a carrier layer disposed therebetween.
Aali, however, teaches a wound protecting device wherein the rim is formed from a deformable member (member 10) and comprises a double-sided adhesive (adhesive can be applied to both the surface in contact with skin and the surface that is not in contact with skin for attachment to the dressing – para [0015-0016]), said skin adhesion layer (lower surface 14 configured to be in contact with the skin – para [0036]) comprising a first adhesive (para [0015;0036]) and said rim adhesion layer (upper surface 13 not in contact with skin – para [0036]) comprising a second adhesive (para [0016;0036]), said first and second adhesives arranged on opposite sides of a carrier layer disposed therebetween (the deformable member 10 is provided between the adhesive layers applied to surfaces 13 and 14). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the skin adhesion rim of LaGreca comprising a double-sided adhesive, said skin adhesion layer comprising a first adhesive and said rim adhesion layer comprising a second adhesive, said first and second adhesives arranged on opposite sides of a carrier layer disposed therebetween, as taught by Aali, in order to permit the rim to be attached to elements on both sides without the need for additional fastening means.
With respect to claim 7, LaGreca in view of Aali discloses the wound cover substantially as claimed (see rejection of claim 6) and Aali further teaches at least one blocker releasably secured to said first adhesive of said skin adhesion layer of said skin adhesion rim (the adhesive material may be covered by a strip or a film that can be peeled off at the time of use – para [0036]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of LaGreca in view of Aali to further include at least one blocker releasably secured to said first adhesive of said skin adhesion layer of said skin adhesion rim, as taught by Aali, in order to protect the adhesive prior to use.
With respect to claim 16, LaGreca discloses a mobile wound cover (dressing system 10 which comprises a reclosable dressing – para [0025]; the reclosable dressing is interpreted as being mobile to permit opening and closing multiple times), comprising: a skin adhesion rim (base member 20 comprised of annulus 22) comprising an adhesive (adhesive on lower side – para [0026]) and a first aperture therein (base member 20 is an annulus or other shape that defines or encompasses an open area at the center for accommodating a wound W – see para [0026] and fig 1-2); a protective rim (top layer 24), having a skin surface (lower surface of layer 24 which is the surface that faces and is configured to attach to base member 20 in fig 1) and a cover surface (upper surface of layer 24 which is the surface that faces and is configured to attach to member 30 in fig 1), said skin surface (lower surface of layer 24) secured to said rim adhesion layer (upper surface of annulus 22) of said skin adhesion rim (annulus 22 of base 20) (layer 24 is adhered to the top of annulus 22 – para [0026]), said protective rim (24) having a second aperture therein (has same size and shape as annulus 22 – para [0026]; thus, layer 24 is an annulus or other shape that defines or encompasses an open area at the center for accommodating a wound W like annulus 22 of base 20 – see para [0026] and fig 1-2); and, a cover (cover/top member 30 comprising a sheet 34; fig 1), said cover (30) arranged to removably engage said cover surface of said protective rim (upper surface of layer 24)(member 30 is removably adhered to the top of base member 20 via attachment between annulus 32 and layer 24 – see para [0026-0029] and figs 1-2),
LaGreca does not, however, explicitly disclose said cover surface of the protective rim having a backing fixedly secured thereto or said cover comprising: a double-sided adhesive; a film fixedly secured to a first side of said double-sided adhesive; and, a blocker fixedly secured to a portion of a second side of said double-sided adhesive, wherein said backing of said protective rim comprises a single-sided adhesive having a blocker surface and wherein said double-sided adhesive of said cover is adapted to releasably secure to said blocker surface of said single-sided adhesive on said backing of said protective rim, thereby removably covering a proximal opening of said second aperture.
Lavender teaches a similar wound cover which comprises a protective rim (base 11) having an aperture therein (opening 16) wherein a cover surface of the rim has a backing fixedly secured thereto (backing 14 of base 11) and a double-sided adhesive (double-sided adhesive tape 21) with a film fixedly secured to a first side of said double-sided adhesive (secured to the distal surface of cover film 19 as shown in fig 2) and adapted to releasably secure to said backing of said protective rim (the double sided adhesive on cover 19 permits releasable attachment to backing 14 of base 11; see col 5 line 54 – col 6 line 25) thereby removably covering a proximal opening of said aperture (as shown in figs 1-2). Lavender further teaches a single-sided adhesive secured to said cover surface of said rim (barrier 13 which is composed of adhesive – col 3 lines 62-63), said single-sided adhesive comprising an adhesive surface adhered to said cover surface of said rim and an oppositely disposed blocker surface (one side has exposed adhesive when release sheet 15 is removed while the opposite surface includes a backing 14 as shown in fig 2); wherein the double-sided adhesive (double-sided adhesive tape 21) is secured to said distal surface of said cover (secured to the distal surface of cover film 19 as shown in fig 2) and adapted to releasably adhere to said blocker surface of said single-sided adhesive (the double sided adhesive on cover 19 permits releasable attachment to backing 14 of base 11; see col 5 line 54 – col 6 line 25).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of LaGreca so that said cover surface of the protective rim having a backing fixedly secured thereto or said cover comprising: a double-sided adhesive; a film fixedly secured to a first side of said double-sided adhesive; and, a blocker fixedly secured to a portion of a second side of said double-sided adhesive, wherein said backing of said protective rim comprises a single-sided adhesive having a blocker surface and wherein said double-sided adhesive of said cover is adapted to releasably secure to said blocker surface of said single-sided adhesive on said backing of said protective rim, thereby removably covering a proximal opening of said second aperture, as taught by Lavender, in order to permit repeated opening and resealing of the cover against the base (see Lavender col 6 lines 12-25).
Lavender further teaches a blocker secured to a portion of a second surface of said double-sided adhesive (release sheet 22 – col 5 lines 54-60; fig 2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of LaGreca in view of Lavender to include a blocker secured to a portion of a second surface of said double-sided adhesive as taught by Lavender in order to protect the adhesive prior to use.
LaGreca also does not disclose that the skin adhesion rim comprises a double-sided adhesive and that said skin surface of said protective rim is fixedly secured to one side of said double-sided adhesive of said skin adhesion rim.
Aali, however, teaches a wound protecting device wherein each rim is formed from a deformable member (member 10) and can be stacked on top of each other (as shown in fig 13) wherein each rim comprises a double-sided adhesive (adhesive can be applied to both surfaces; for a member 10 applied to the skin, adhesive can be applied to the surface in contact with skin and the surface that is not in contact with skin – para [0015-0016;0036]), wherein said skin surface of said protective rim is fixedly secured to one side of said double-sided adhesive of said skin adhesion rim (as shown in fig 13 where two members 10 are stacked, the upper member 10 is interpreted as being a protective rim and the lower member 10 is interpreted as being the skin adhesion rim since it attaches to the user’s skin, as shown in fig 13, the skin facing surface of the upper member 10 (protective rim) is fixedly secured to one side (the upper surface) of said double-sided adhesive of said lower member 10 (skin adhesion rim); para [0054]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the skin adhesion rim of LaGreca in view of Lavender so that it comprises a double-sided adhesive and that said skin surface of said protective rim is fixedly secured to one side of said double-sided adhesive of said skin adhesion rim, as taught by Aali, in order to permit the rim to be attached to elements on both sides without the need for additional fastening means.
With respect to claim 18, LaGreca in view of Lavender and further in view of Aali discloses the wound cover substantially as claimed (see rejection of claim 16) and LaGreca also discloses that said rim (24) is arranged to create a vertical distance between said skin adhesion rim and said cover (as shown in fig 1, the layer 24 has a thickness which inherently creates spacing between annulus 22 of base 20 and sheet 34 of cover 30).
LaGreca does not, however, explicitly disclose that the rim may be comprised of a hydrophilic material.
Lavender teaches a similar wound cover which comprises a protective rim (base 11 which includes backing layer 14) wherein the backing layer is preferably composed from a polyetherimide film (col 4 lines 40-42) wherein polyetherimides are known to be capable of being modified to have either hydrophilic or hydrophobic characteristics. Lavender also teaches that the layer 14 should be formed from a material that is moisture vapor permeable (col 4 lines 28-30). Thus, the polyetherimide film used for backing layer 14 is interpreted as being at least partly hydrophilic so as to be capable of transmitting moisture vapor rather than repelling moisture and liquids. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the rim of LaGreca in view of Lavender and further in view of Aali from a hydrophilic material, such as a polyetherimide as taught by Lavender, in order to permit moisture vapor transmission through the material to prevent moisture from accumulating at a wound site which could cause infection.
With respect to claim 19, LaGreca in view of Lavender and further in view of Aali discloses the wound cover substantially as claimed (see rejection of claim 18) but does not disclose that said rim is comprised of a foam.
Aali, however, teaches a wound protecting device wherein the rim is formed from a deformable member that is made of polyurethane foam is used for its ability to absorb exudate (para [0014]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the rim on the device of LaGreca in view of Lavender and further in view of Aali from foam, like the deformable member of Aali, in order to allow for exudate absorption.
With respect to claim 21, LaGreca in view of Lavender and further in view of Aali discloses the wound cover substantially as claimed (see rejection of claim 16) and LaGreca also discloses that said rim (24) is arranged to create a vertical distance between said skin adhesion rim and said cover (as shown in fig 1, the layer 24 has a thickness which inherently creates spacing between annulus 22 of base 20 and sheet 34 of cover 30).
LaGreca does not, however, explicitly disclose that the rim may be comprised of a hydrophilic material.
Lavender teaches a similar wound cover which comprises a protective rim (base 11 which includes backing layer 14) wherein the backing layer is preferably composed from a polyetherimide film (col 4 lines 40-42) wherein polyetherimides are known to be capable of being modified to have either hydrophilic or hydrophobic characteristics. Lavender also teaches that the layer 14 should be formed from a material that is moisture vapor permeable (col 4 lines 28-30). Thus, the polyetherimide film used for backing layer 14 is interpreted as being at least partly hydrophilic so as to be capable of transmitting moisture vapor rather than repelling moisture and liquids. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the rim of the device of LaGreca in view of Lavender and further in view of Aali from a hydrophilic material, such as a polyetherimide as taught by Lavender, in order to permit moisture vapor transmission through the material to prevent moisture from accumulating at a wound site which could cause infection.
Claim(s) 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over LaGreca (US 2016/0374863) in view of Lavender et al (US 5562107) and further in view of Ha et al (US 2010/0318052).
With respect to claim 10, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 3) and Lavender further teaches that said blocker surface of said single-sided adhesive comprises a polymer (backing 14 is a thermoplastic film – col 4 lines 23-51). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the blocker surface of said single-sided adhesive of LaGreca in view of Lavender from a polymer, as taught by Lavender, since it is 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.
LaGreca in view of Lavender does not, however, disclose that said adhesive surface of said single-sided adhesive comprises one or more of acrylate adhesive or rosin ester.
Ha, however, teaches that suitable adhesives for use in wound dressing articles include adhesives that provide acceptable adhesion to skin and are acceptable for use on skin (e.g., the adhesive should preferably be non-irritating and non-sensitizing) wherein preferred adhesives are pressure sensitive and have a relatively high moisture vapor transmission rate to allow for moisture evaporation and wherein, specifically, suitable pressure sensitive adhesives include those based on acrylates (para [0111]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used an acrylate adhesive for the adhesive surface of said single-sided adhesive on the device of LaGreca in view of Lavender, to provide acceptable adhesion to skin and a relatively high moisture vapor transmission rate to allow for moisture evaporation.
With respect to claim 15, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 12) but does not disclose that both of said first and second adhesives comprise an acrylate adhesive.
Ha, however, teaches that suitable adhesives for use in wound dressing articles include adhesives that provide acceptable adhesion to skin and are acceptable for use on skin (e.g., the adhesive should preferably be non-irritating and non-sensitizing) wherein preferred adhesives are pressure sensitive and have a relatively high moisture vapor transmission rate to allow for moisture evaporation and wherein, specifically, suitable pressure sensitive adhesives include those based on acrylates (para [0111]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used an acrylate adhesive for both of said first and second adhesives on the device of LaGreca in view of Lavender, to provide acceptable adhesion to skin and a relatively high moisture vapor transmission rate to allow for moisture evaporation.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over LaGreca (US 2016/0374863) in view of Lavender et al (US 5562107) with extrinsic evidence from 3M Medical Tape 1509 Product Specifications.
With respect to claim 13, LaGreca in view of Lavender discloses the wound cover substantially as claimed (see rejection of claim 12) and Lavender further teaches that said carrier comprises a polymer wherein said polymer comprises polyethylene (the double sided adhesive used can be, specifically, adhesive #1509 by 3M – col 5 lines 46-48; 3M adhesive #1509 is a double sided medical tape that consists of a transparent polyethylene film coated on two sides with an acrylic adhesive – see 3M Medical Tape 1509 Product Specifications pg 5 of 8). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of LaGreca in view of Lavender so that the double sided tape includes a carrier comprised of a polymer wherein said polymer comprises polyethylene, as taught by Lavender, since it is 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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over LaGreca (US 2016/0374863) in view of Lavender et al (US 5562107) and further in view of Aali (US 2006/0235347) with extrinsic evidence from 3M Medical Tape 1509 Product Specifications.
With respect to claim 17, LaGreca in view of Lavender and further in view of Aali discloses the wound cover substantially as claimed (see rejection of claim 16) and LaGreca further discloses the film cover (30) being at least semi-transparent (sheet 34 of top member 30 is preferably translucent or clear – para [0030]). Additionally, Lavender further teaches the double sided adhesive used can be, specifically, adhesive #1509 by 3M (col 5 lines 46-48). 3M adhesive #1509 is a double sided medical tape that consists of a transparent polyethylene film coated on two sides with an acrylic adhesive (see 3M Medical Tape 1509 Product Specifications pg 5 of 8). Thus, the double sided 3M adhesive #1509 is transparent. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of LaGreca in view of Lavender and further in view of Aali so that the double sided adhesive is at least semi-transparent, like the double sided 3M adhesive #1509 that is used on the device of Lavender, in order to permit viewing of a covered treatment area through the device without requiring removal.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 22 and 24 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Specifically, Claims 22 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 22 positively recites part of the human body in combination with the device, as for example: in claim 22, the limitation reciting “…a cover having a proximal surface facing away from a wound…” of the claim encompasses a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claim 22 has been rejected under 35 USC 101. It is suggested that claim 22 be amended to recite “a proximal surface configured to face away from a wound” in order to overcome this rejection. Claim 24 depends directly or indirectly from a rejected claim and, therefore, contain the same deficiencies as the claim from which it depends.
Allowable Subject Matter
Claims 22 and 24 are free of art but are still subject to the rejections provided above. Additionally, any changes or amendments to the claims may result in new rejections under 35 USC 102 and/or 35 USC 103 being made in future Actions.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of independent claim 22 could either not be found or was not suggested in the prior art of record. The subject matter not found was a mobile wound cover that includes a cover comprising a flexible film with a first adhesive disposed on the distal surface and configured to releasably adhere to a cover surface of a protective rim and a second adhesive disposed on the proximal surface wherein said flexible film is configured to be folded such that at least a portion of said first adhesive on said distal surface releasably adheres to said second adhesive on said proximal surface, thereby allowing said cover to be temporarily secured to itself when detached from said protective rim, in combination with the other elements in the claims. Claim 24 depends from claim 22 and thus contains the same allowable limitations.
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 12/15/25 have been fully considered as follows:
Regarding the objections to the specification, Applicant’s amendments to the abstract have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome the objections, but new objections have been given as necessitated by the amendments to the claims (see above).
Regarding the claim rejections under 35 USC 112, Applicant’s amendments to the claims have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 102, Applicant’s arguments on pages 11-12 have been noted but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to claim 1.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 12-14 have been fully considered but are not persuasive.
Specifically, the Office has noted Applicant’s arguments on page 12 that the Office has erred in equating Lavender's 'backing 14' with the claimed "oppositely disposed blocker surface" because Lavender's 'backing 14' is explicitly described as a thin, elastomeric, structural film (See Lavender, col. 4, 11. 40-42) that forms a part of the base itself whereas the claimed invention's "blocker surface" is the non-adhesive top surface of a single-sided adhesive component that is itself a functional part of the securement mechanism. The Office is not persuaded by this argument, however, because the claims do not specifically define that the blocker surface is the “non-adhesive top surface” of the single sided adhesive component. Furthermore, the barrier 13 in Lavender has been interpreted as being a single sided adhesive component with a non-adhesive, top surface (interpreted as being equivalent to the claimed “blocker surface”) because one side of barrier 13 has exposed adhesive when release sheet 15 is removed while the opposite surface includes a backing 14 as shown in fig 2. Therefore, for at least these reasons, the Office is not persuaded by these arguments.
The Office has also noted Applicant’s argument on page 12 that the Office's proposed combination improperly conflates a structural base layer with a functional surface of an adhesive component-another layer of the invention's multi- component/multi-layer construction because Lavender teaches adhering a double-sided tape (21) to a structural film ('backing 14') and does not teach adhering a double-sided adhesive to the blocker surface of another adhesive component to form a re-closable bond. The Office is not persuaded by this argument, however, because as discussed above, the barrier 13 in Lavender has been interpreted as being a single-sided adhesive component and a double sided adhesive 21 is attached to the non-adhesive top surface 14 of this component. If the claimed “blocker surface” includes structural features or characteristics which would differentiate this surface from the film material of backing 14 in Lavender, such features/characteristics should be defined in the claims. However, in the absence of any such features being defined, the Office maintains that the backing 14 which forms the non-adhesive, top surface of barrier 13 in Lavender, is equivalent to the claimed “blocker surface” of the device of claim 1 of the present application.
The Office has also noted Applicant’s arguments on page 13 that the claimed invention differs from the prior art of record because Lavender discloses only the rim component ('base 11') with its integrated structural film ('backing 14') but there is no second adhesive component on Lavender's rim and to arrive at the claimed invention, one skilled in the art would be required to ignore Lavender's teaching of adhering to the 'backing 14' and instead introduce an entirely new component-a single-sided adhesive-onto the rim for the sole purpose of creating a different attachment interface. The Office respectfully disagrees because as discussed above, the barrier 13 has been interpreted as being a single sided adhesive structure with a non-adhesive top surface (blocker surface) defined by backing 14. Additionally, Lavender teaches a second adhesive component because the double sided adhesive tape 21 is attached to the blocker surface (backing 14) of the single sided adhesive component (barrier 13). Therefore, for at least these reasons, the Office is not persuaded by these arguments.
The Office has also noted Applicant’s arguments on page 13 that the alleged combination of Lavender and LaGreca is only made possible by viewing it through the lens of Applicants' own disclosure which is the definition of impermissible hindsight. 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). As noted in the claim rejections provided above, the Office has indicated that the combination of Lavender with LaGreca would have been obvious to one having ordinary skill in the art in order to permit repeated opening and resealing of the cover against the base as taught by Lavender (see Lavender col 6 lines 12-25). Thus, the conclusion of obviousness is based on knowledge which was explicitly disclosed in the prior art and, therefore, was within the level of ordinary skill at the time the claimed invention was made.
The Office has also noted Applicant’s arguments on page 13 that there would have been no reason or motivation for one skilled in the art to modify LaGreca in the manner suggested because there is no suggestion in the art to add a second adhesive component (the single-sided adhesive) to the base merely to use its blocker surface as the attachment point. The Office is not persuaded by this argument, however, because as noted in the claim rejections above, one would have been motivated to make such a modification in order to permit repeated opening and resealing of the cover against the base as taught by Lavender (see Lavender col 6 lines 12-25). Therefore, the Office maintains that one of ordinary skill in the art would have been motivated to modify LaGreca as outlined in the claim rejections above.
Therefore for at least the reasons outlined above, the Office maintains that the prior art of record reads on claim 1 substantially as recited in the present application.
The Office has also noted Applicant’s arguments on pages 13-14 regarding claim 16 but for at least the same reasons as provided above with respect to claim 1, the Office is not persuaded by these arguments.
The Office has noted Applicant’s arguments on pages 14-16 regarding new claims 22-24 and agrees that these claims include allowable subject matter as noted 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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786