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 .
In light of the amendments to the claims filed 01/02/2026 in which claims 1, 10, 16-17, and 19 were amended, claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims no priority.
Claims 1-20 receive the filing date of the instant application, filed on 08/23/2023.
Response to Arguments
Objections to the Drawings
The objections to the drawings are withdrawn in view of the amendments to the specification filed 01/02/2026.
Objections to the Specification
The objections to the drawings are withdrawn in view of the amendments to the specification filed 01/02/2026.
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 01/02/2026.
Rejections to the Claims under 35 U.S.C. 103
Applicant provided amendments to the claims for a telephonic interview that took place 12/31/2026. With said amendments, applicant provided arguments to the rejections of the independent claims 1, 16, and 19 as the prior art to Clark and Haverstock may not read on the amendments. The examiner suggested further amendments to claim 19 to read over the rejection in light of Clark and Haverstock, and then noted that the amendments to the independent claims may read over the rejection of record in the Office Action filed 10/03/2025; however, the examiner further noted that more search and consideration would be required in light of the amendments. The applicant has similarly noted this in the Applicant Arguments filed 01/02/2026.
Upon further search and consideration, a new grounds of rejection is made in view of Hynes as explained below. The amendments to the claims have necessitated the new grounds of rejection.
Claim Interpretation
The Examiner recognizes claim 15 as a "product-by-process" claim. 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 of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim 15 to require the skin closure system to comprise the following structural elements in addition to those in the claims from which they depend: triclosan within the elongated body.
In the prior art rejection in this Office action, Examiner considers claim 15 to be met when a reference teaches these structural limitations.
Claim Objections
Claims 16 and 19 are objected to because of the following informalities:
Claim 16 recites the limitation “wherein the activate pharmaceutical ingredient” in ln. 20. This should read “wherein the active pharmaceutical ingredient”.
Claim 19 recites the limitation “wherein the activate pharmaceutical ingredient” in ln. 20. This should read “wherein the active pharmaceutical ingredient”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-7, 9-10, and 16-17 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by US/2024/0009341 A1 to Hynes.
Regarding claim 1, Hynes discloses a skin closure system (Figures, dressing 10), comprising:
(a) a surgical mesh including a first upper side and a first lower side (Fig. 4, mesh 40 comprising upper side 42 and lower wound-facing side 44), wherein the first lower side is configured to adhere to a section of skin of a patient that surrounds a wound such that the surgical mesh surrounds the wound (Fig. 4-6, mesh 40 comprising pressure-sensitive adhesive 50 on lower side 44 surrounding wound 7; para. 0032), wherein the first lower side of the surgical mesh comprises a first area (Fig. 2 showing wound-facing side of dressing 10; para. 0028);
(b) a topical skin adhesive configured to be applied to the first upper side of the surgical mesh (Fig. 5-6, polymerizable adhesive 105 applied to upper side 42 of mesh 40), wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound (para. 0050-0054); and
(c) a strip configured to be secured relative to the surgical mesh (Figures, strip 60 comprising 62/64 configured to be secured relative to mesh 40; para. 0032-0033), the strip comprising:
(i) an elongated body comprising a second upper side and a second lower side (Fig. 4-6, elongated absorbent body 64 comprising an upper side with masking layer 62 and a lower side in contact with wound 7), wherein the second lower side comprises a second area, wherein the second area of the second lower side of the elongated body is smaller than the first area of the first lower side of the surgical mesh (para. 0028), wherein the elongated body is configured to extend longitudinally along a central portion of the first lower side of the surgical mesh while the surgical mesh surrounds the wound such that the elongated body directly overlies the wound and the central portion of the surgical mesh overlies the strip (Fig. 2-6; para. 0028) and
(ii) an active pharmaceutical ingredient integrated into the elongated body, wherein the active pharmaceutical ingredient is configured to diffuse from the elongated body toward the wound after the protective layer over the wound is formed by the topical skin adhesive curing within the surgical mesh (para. 0010; para. 0040; para. 0052, masking layer 62 may prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound).
Regarding claim 3, the cited prior art discloses the invention of claim 1. Hynes discloses wherein the elongated body is configured to inhibit penetration of the topical skin adhesive through the elongated body to the second lower side of the elongated body (para. 0052, masking layer 62 may entirely prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound).
Regarding claim 5, the cited prior art discloses the invention of claim 3. Hynes discloses wherein the elongated body comprises a material that is impervious to penetration of the topical skin adhesive (para. 0052, masking layer 62 may entirely prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound).
Regarding claim 6, the cited prior art discloses the invention of claim 1. Hynes discloses wherein the surgical mesh comprises a first width, wherein the elongated body comprises a second width, wherein the second width is smaller than the first width (Fig. 2; para. 0028).
Regarding claim 7, the cited prior art discloses the invention of claim 1. Hynes discloses a mask interposed between the second upper surface of the elongated body and the first upper surface of the surgical mesh (Fig. 4-6, masking layer 62).
Regarding claim 9, the cited prior art discloses the invention of claim 7. Hynes discloses wherein the mask comprises a material that is impervious to penetration of the topical adhesive (para. 0052, masking layer 62 may entirely prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound).
Regarding claim 10, the cited prior art discloses the invention of claim 1. Hynes discloses wherein the strip further comprises a pressure sensitive adhesive associated with the second lower side of the elongated body (para. 0027).
Regarding claim 16, Hynes discloses a skin closure system (Figures, dressing 10), comprising:
(a) a surgical mesh including a first upper side and a first lower side (Fig. 4, mesh 40 comprising upper side 42 and lower wound-facing side 44), wherein the first lower side is configured to adhere to a section of skin of a patient that surrounds a wound such that the surgical mesh surrounds the wound (Fig. 4-6, mesh 40 comprising pressure-sensitive adhesive 50 on lower side 44 surrounding wound 7; para. 0032), wherein the first lower side of the surgical mesh comprises a first area (Fig. 2 showing wound-facing side of dressing 10; para. 0028);
(b) a topical skin adhesive configured to be applied to the first upper side of the surgical mesh (Fig. 5-6, polymerizable adhesive 105 applied to upper side 42 of mesh 40), wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound (para. 0050-0054); and
(c) a strip configured to be secured relative to the surgical mesh (Figures, strip 60 comprising 62/64 configured to be secured relative to mesh 40; para. 0032-0033), the strip comprising:
(i) an elongated body comprising a second upper side and a second lower side (Fig. 4-6, elongated absorbent body 64 comprising an upper side with masking layer 62 and a lower side in contact with wound 7), wherein the second lower side comprises a second area, wherein the second area of the second lower side of the elongated body is smaller than the first area of the first lower side of the surgical mesh (para. 0028), wherein the elongated body is configured to extend longitudinally along a central portion of the first lower side of the surgical mesh while the surgical mesh surrounds the wound such that the elongated body directly overlies the wound (Fig. 2-6; para. 0028) and
(ii) an active pharmaceutical ingredient associated with the elongated body, wherein the active pharmaceutical ingredient is configured to diffuse from the elongated body toward the wound after the protective layer over the wound is formed (para. 0010; para. 0040; para. 0052, masking layer 62 may prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound); and
(d) a masking body extending longitudinally with the elongated body (Fig. 2-6, masking layer 62; para. 0036; para. 0052), wherein the masking body is interposed between the second upper side of the elongated body and the first upper side of the surgical mesh (Fig. 2-6, masking layer 62), wherein the masking body is configured to inhibit the topical skin adhesive from penetrating from the surgical mesh outside the elongated body into the elongated body (para. 0052, masking layer 62 may entirely prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound).
Regarding claim 17, the cited prior art discloses the invention of claim 17. Hynes discloses wherein the masking body is a component of the strip and is directly attached to the second upper side of the elongated body (Fig. 2-6, masking layer 62; para. 0036).
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 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.
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 2, 4, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hynes as applied above.
Regarding claim 2, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the second area of the second lower side of the elongated body is between 5 percent and 30 percent of the first area of the first lower side of the surgical mesh.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the cited prior art to have the second area of the second lower side of the elongated body be between 5-30 percent of the first area of the first lower side of the surgical mesh since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the cited prior art would not operate differently with the claimed proportion and since the surgical mesh is meant to provide the adhesive to the wound site the device would function appropriately having the claimed proportion. Further, it appears that applicant places no criticality on the proportion claimed, indicating simply that the proportion may simply be within the range claimed (specification para. 00051).
Regarding claim 4, the cited prior art discloses the invention of claim 3. Hynes further discloses: wherein the surgical mesh comprises a first porosity (para. 0028), and wherein the elongated body comprises a second porosity (para. 0035-0036).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the second porosity is lower than the first porosity.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to have the second porosity lower than the first porosity since there are only a finite number of predictable solutions (lower, equal, greater). Hynes discloses that the mesh must be porous enough to allow the polymerizable adhesive to pass through the mesh (para. 0016; para. 0050-0054) and discloses that the absorbent strip may be made to prevent the polymerizable adhesive from penetrating the wound even without the masking layer (para. 0052). Thus, making the second porosity lower than the first porosity would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 8, the cited prior art discloses the invention of claim 7. Hynes further discloses: wherein the mask is directly on top of the second upper surface of the elongated body (Fig. 4-6, masking layer 62 directly on top of elongated absorbent body 64), wherein the mask extends longitudinally along the length of the elongated body (para. 0036; para. 0052).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the masking body extends longitudinally along the entire length of the elongated body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the cited prior art to comprise the masking body extending longitudinally along the entire length of the elongated body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the cited prior art would not operate differently with the claimed proportion and since the masking layer is optional the device would function appropriately having the claimed proportion. Further, it appears that applicant places no criticality on the proportion claimed, indicating simply that the proportion “may” be as claimed (specification para. 00067).
Regarding claim 18, the cited prior art discloses the invention of claim 16. Hynes further discloses: wherein the masking body extends longitudinally along the length of the elongated body (para. 0036; para. 0052).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the masking body extends longitudinally along the entire length of the elongated body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the cited prior art to comprise the masking body extending longitudinally along the entire length of the elongated body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the cited prior art would not operate differently with the claimed proportion and since the masking layer is optional the device would function appropriately having the claimed proportion. Further, it appears that applicant places no criticality on the proportion claimed, indicating simply that the proportion “may” be as claimed (specification para. 00067).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hynes as applied above, and further in view of U.S. Patent no. 4,976,726 A to Haverstock.
Regarding claim 11, the cited prior art discloses the invention of claim 10; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the pressure sensitive adhesive is disposed on the second lower side of the elongated body in a stripe pattern.
Haverstock teaches a skin closure device comprising an elongated body wherein the adhesive is disposed on the second lower side of the elongated body in a stripe pattern to allow for a more open space for medication to drain out (Fig. 7, elongated medicated strip 32 comprising adhesive 44/46 provided in strips; col. 3 ln. 51-68 and col. 4 ln. 1).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the cited prior art to comprise the adhesive disposed in a stripe pattern as taught by Haverstock, because Haverstock discloses that this provides a more open space for the medication to drain out (col. 3 ln. 51-68 and col. 4 ln. 1).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hynes as applied above, and further in view of US/2021/0212676 A1 to Quintero.
Regarding claim 12, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the surgical mesh comprises polyethylene.
Quintero teaches a skin closure device wherein a surgical mesh comprises polyethylene (para. 0074 Fig. 1, mesh 20).
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 mesh of Hynes that allows for the infiltration of cyanoacrylate adhesive and acts as a skin closure mechanism, for the polyethylene mesh of Quintero since these mechanisms perform the same function of closing skin and allowing for infiltration of cyanoacrylate adhesive (Quintero: para. 0040; para. 0088-0091). Simply substituting one mesh skin closure means for another would yield the predicable result of allowing for skin closure by the curing of the adhesive. See MPEP 2143.
Further, as Quintero discloses a mesh that may use polyethylene, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use polyethylene as disclosed by Quintero in the skin closure device suggested by the prior art, 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. See MPEP 2144.07.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hynes as applied above, and further in view of US/2012/0310186 A1 to Moghe.
Regarding claim 13, the cited prior art discloses the invention of claim 1. Hynes further discloses: wherein the active pharmaceutical ingredient comprises an antimicrobial (para. 0010; para. 0040).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the active pharmaceutical ingredient comprises triclosan.
Moghe teaches a dressing comprising an elongated drug-eluting body comprising a triclosan antimicrobial (para. 0038-0040; Fig. 1, non-stick film 50).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the active pharmaceutical ingredient of the cited prior art to comprise triclosan as taught by Moghe, because Hynes teaches the use of an antimicrobial at a wound (para. 0010; para. 0040), and Moghe teaches that triclosan is an antimicrobial (para. 0040).
Regarding claim 14, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the elongated body comprises polyethylene terephthalate.
Moghe teaches an elongated drug-eluting body comprising polyethylene terephthalate to ensure that the body does not adhere to the wound (para. 0021; para. 0025; para. 0038-0040; para. 0048; Fig. 1, non-stick film 50).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the elongated body of the cited prior art to comprise polyethylene terephthalate as taught by Moghe, because Moghe teaches that this material does not adhere to the wound during use (para. 0021; para. 0025).
Further, as Moghe discloses a drug carrier that may use polyethylene terephthalate, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use polyethylene terephthalate as disclosed by Moghe in the skin closure device suggested by the prior art, 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. See MPEP 2144.07.
Regarding claim 15, the cited prior art discloses the invention of claim 1. Hynes further discloses: wherein the active pharmaceutical ingredient comprises an antimicrobial (para. 0010; para. 0040).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the active pharmaceutical ingredient comprises triclosan, the method comprising: (a) positioning the elongated body and a source reservoir within a sealed pouch, wherein the source reservoir comprises triclosan; (b) positioning the sealed pouch within a chamber; and (c) subjecting the chamber to an ethylene oxide sterilization process and thereby urging the triclosan to migrate from the source reservoir to the elongated body.
Per the claim interpretation section, this claim will be read upon if the prior art teaches triclosan within the elongated body.
Moghe teaches a dressing comprising an elongated drug-eluting body comprising a triclosan antimicrobial (para. 0038-0040; Fig. 1, non-stick film 50).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the active pharmaceutical ingredient of the cited prior art to comprise triclosan as taught by Moghe, because Hynes teaches the use of an antimicrobial at a wound (para. 0010; para. 0040), and Moghe teaches that triclosan is an antimicrobial (para. 0040).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US/2024/0009341 A1 to Hynes in view of U.S. Patent no. 4,976,726 A to Haverstock and US/2018/0303967 A1 to Quintero.
Regarding claim 19, Hynes discloses a skin closure system (Figures, dressing 10), comprising:
(a) a surgical mesh including a first upper side and a first lower side (Fig. 4, mesh 40 comprising upper side 42 and lower wound-facing side 44), wherein the first lower side is configured to adhere to a section of skin of a patient that surrounds a wound such that the surgical mesh surrounds the wound (Fig. 4-6, mesh 40 comprising pressure-sensitive adhesive 50 on lower side 44 surrounding wound 7; para. 0032), wherein the first lower side of the surgical mesh comprises a first area (Fig. 2 showing wound-facing side of dressing 10; para. 0028);
(b) a topical skin adhesive configured to be applied to the first upper side of the surgical mesh (Fig. 5-6, polymerizable adhesive 105 applied to upper side 42 of mesh 40), wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound (para. 0050-0054); and
(c) a strip comprising (Figures, strip 60 configured to be secured relative to mesh 40; para. 0032-0033):
(i) an elongated body comprising a second upper side and a second lower side (Fig. 4-6, elongated absorbent body 64 comprising an upper side with masking layer 62 and a lower side in contact with wound 7), wherein the second lower side comprises a second area, wherein the second area of the second lower side of the elongated body is smaller than the first area of the first lower side of the surgical mesh (para. 0028), wherein the elongated body is configured to extend longitudinally along a central portion of the first lower side of the surgical mesh while the surgical mesh surrounds the wound such that the second lower side of the elongated body is positioned to directly contact the top of the wound (Fig. 2-6; para. 0028) and
(ii) an active pharmaceutical ingredient associated with the elongated body, wherein the active pharmaceutical ingredient is configured to diffuse from the elongated body toward the wound after the protective layer over the wound is formed (para. 0010; para. 0040; para. 0052, masking layer 62 may prevent adhesive penetrating through to the wound and/or strip 60 without masking layer 62 is sufficient to prevent adhesive penetrating through to the wound); and
(d) a pressure sensitive adhesive extending longitudinally along the second lower side of the elongated body (para. 0027).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose a soluble pressure sensitive adhesive extending longitudinally along the second lower side of the elongated body, wherein the soluble pressure sensitive adhesive is configured to inhibit the topical skin adhesive from penetrating into the wound prior to the topical skin adhesive curing, wherein the soluble pressure sensitive adhesive is configured to dissolve, thereby exposing the second lower side of the elongated body to the wound, after the protective layer of the wound is formed.
Quintero teaches a skin closure system (Fig. 8d) comprising a soluble pressure sensitive adhesive extending longitudinally along the second lower side (para. 0060-0061; Fig. 8d, soluble PSA 30 extending longitudinally alongside opposite upper surface 22), wherein the soluble pressure sensitive adhesive is configured to inhibit the topical skin adhesive from penetrating into the wound prior to the topical skin adhesive curing, wherein the soluble pressure sensitive adhesive is configured to dissolve, thereby exposing the second lower side to the wound, after the protective layer of the wound is formed to create a drainage channel (para. 0060-0061).
Haverstock further teaches a skin closure device comprising an elongated body wherein the adhesive is disposed on the second lower side of the elongated body in a stripe pattern to allow for a more open space for medication to drain out (Fig. 7, elongated medicated strip 32 comprising adhesive 44/46 provided in strips; col. 3 ln. 51-68 and col. 4 ln. 1).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the adhesive of the cited prior art as taught by Quintero, because Quintero teaches that utilizing a pressure sensitive adhesive on the lower side of the skin closure system that dissolves after curing of the topical skin adhesive creates an area as a drainage channel of the skin closure system that does not have the cured protective layer (para. 0060-0061). Further, Haverstock teaches that providing an open channel under the strip provides a space that is more open for the medication to drain out (col. 3 ln. 63-68 and col. 4 ln. 1-8).
Regarding claim 20, the cited prior art suggests the invention of claim 19; however, the combination of the prior art differ from the instantly claimed invention in that they fail to disclose wherein the soluble pressure sensitive adhesive is coextensive with the second lower side of the elongated body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the cited prior art to comprise the soluble pressure sensitive adhesive coextensive with the elongated body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the cited prior art would not operate differently with the claimed proportion and since the soluble pressure sensitive adhesive is configured to dissolve to create an open channel the device would function appropriately having the claimed proportion. Further, it appears that applicant places no criticality on the proportion claimed, indicating simply that the proportion may simply be as claimed (specification para. 000113).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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.
/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 4 May 2026
Prosecution Insights