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 .
Response to Arguments
Applicant's arguments filed 09/23/2025 have been fully considered but they are not persuasive. Applicant argues that the combination of Tolia/Bentley is nonanalogous because Tolia is drawn to a transdermal drug delivery device and Bentley is drawn to an adhesive wound cover film, stating that Tolia and Bentley are not in the same field of endeavor. However, both the structure of Tolia and Bentley are drawn to medical devices applied to the human body via adhesives which are protected by release liners. Thus, both references and the combination of references are analogous to the claimed invention.
Applicant further argues that the combination of Tolia/Bentley does not teach the amended limitations of claim 1 because allegedly there is no rationale or motivation from Bentley to teach two liners over two adhesives. However, Tolia teaches two adhesive surfaces, and the multiple protective liners taught by Bentley are included based on the motivation taught by Bentley to protect a respective portion of adhesive of the cover prior to use of the cover, and to permit secure handling and maneuvering of the cover when applying it over the wound bed (Bentley ¶[0060]). One of ordinary skill would have seen the benefit of protecting one of the two adhesive regions of Tolia during application by including multiple release liners as taught by Bentley. One of ordinary skill would also place the discrete release liners over the different adhesive regions, and since the Tolia’s first adhesive region 521 is centrally located, one of ordinary skill would recognize the benefit of placing a release liner over the central portion of the device.
Applicant argues that Tolia/Quintero/Bentley does not teach the newly amended limitation of claim 30: “a sealing layer configured to provide an airtight seal over a wound”. However, as set forth in the rejection below, Tolia teaches the claimed limitation because backing layer 511 may be made from impermeable materials and thus is fully capable of providing an airtight seal (Tolia ¶[0062]).
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 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 1-4, 6-10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tolia (US 20170291020 A1) in view of Bentley (US 20090105670 A1).
Regarding Claim 1, Tolia discloses an apparatus for sealing a wound site (Fig 5 ¶[0033] double disk system 500 comprises an outer disk layer with a pressure sensitive adhesive, and is thus capable of sealing a wound site), the apparatus comprising: a fixation strip (Fig 5, 500), comprising: a wound sealing layer comprising a first adhesive surface (Fig 5 ¶[0045] layer 521 comprises adhesive surface on which adhesives 525 and 524 are disposed), the first adhesive surface comprising a first adhesive (Fig 5, adhesive layer 525); an adhering layer overlying the wound sealing layer and extending outward beyond the wound sealing layer (Fig 5, outer disk adhesive film 511), the adhering layer comprising a second adhesive surface comprising a second adhesive (Fig 5, lower surface of 511 comprises adhesive film 512 disposed thereon); and at least one protective liner removably adhered to the first adhesive surface of the wound sealing layer and/or the second adhesive surface of the adhering layer (Fig 5, first release liner 530 is adhered to both the first adhesive surface 525 of 521 and the second adhesive surface 512 of 511).
Tolia is silent regarding a first protective liner and a second protective liner, and wherein the first protective liner is removably adhered to the first adhesive surface of the wound sealing layer and the second protective liner is removably adhered to the second adhesive surface of the adhering layer.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, wherein the at least one protective liner (Figs 3-4, releasably securable liner 32) further comprises a first protective liner (Figs 3-4, release liner 32C) and a second protective liner (Figs 3-4, release liner 32A), and wherein the first protective liner is removably adhered to a central portion of adhesive surface of an adhesive layer (Figs 3-4, 32C is removably adhered to central portion of adhesive 30) and the second protective liner is removably adhered to the second adhesive surface of the adhering layer (Figs 3-4, 32A is releasably adhered to outer portion of adhesive 30) to protect a respective portion of adhesive of the cover prior to use of the cover, and to permit secure handling and maneuvering of the cover when applying it over the wound bed (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia so that the at least one protective liner further comprises a first protective liner and a second protective liner, and wherein the first protective liner is removably adhered to a central portion of adhesive surface of an adhesive layer and the second protective liner is removably adhered to the second adhesive surface of the adhering layer, as taught by Bentley to protect a respective portion of adhesive of the strip prior to use of the strip, and to permit secure handling and maneuvering of the strip when applying it over the wound bed (as motivated by Bentley ¶[0060]). In combination, the first protective liner 32C taught by Bentley would be disposed over the first adhesive surface 525 of the wound sealing layer taught by Tolia because Tolia’s 525 is also centrally located.
Regarding Claim 2, Tolia discloses that the fixation strip is configured for placement over an edge of a wound dressing (Fig 5, 500 comprises adhesive 512 on its outer edges and is thus fully capable of being placed over an edge of a wound dressing).
Regarding Claim 3, Tolia discloses that the fixation strip comprises a width and a length (Fig 4 shows that 400 has a width and length, with 400 being analogous to 500), the second adhesive extending along the width of the fixation strip (Fig 5 shows adhesive layer 512 extending along the width of 500).
Regarding Claim 4, Tolia discloses that the first adhesive extends along a portion of the width of the fixation strip (Fig 5, adhesive 525 extends along a portion of the overall width of 500).
Regarding Claim 6, Tolia is silent whether the first protective liner comprises a release handle configured to remove the first protective liner from the wound sealing layer when actuated, and wherein the second protective liner comprises a release handle configured to remove the second protective liner from the adhering layer when actuated.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, wherein the first protective liner comprises a release handle configured to remove the first protective liner from the wound sealing layer when actuated (Figs 3-4 ¶[0060-0061], liner 32C comprises flange 60 which can be grasped to remove the liner from the cover), and wherein the second protective liner comprises a release handle configured to remove the second protective liner from the adhering layer when actuated (Figs 3-4 ¶[0060-0061], liner 32A comprises flange 58 which can be grasped to remove the liner from the cover) to allow the user to grasp the liner portions to remove the liner from the cover and permit secure handling and maneuvering of the cover in order to place the cover over the wound (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia so that the first protective liner comprises a release handle configured to remove the first protective liner from the wound sealing layer when actuated, and wherein the second protective liner comprises a release handle configured to remove the second protective liner from the adhering layer when actuated, as taught by Bentley to allow the user to grasp the liner portions to remove the liner from the strip and permit secure handling and maneuvering of the strip in order to place the strip over the wound (as motivated by Bentley ¶[0060]).
Regarding Claim 7, Tolia is silent regarding a central protective liner.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, including a central protective liner (Figs 3-4, 32C) to protect a respective portion of adhesive of the cover prior to use of the cover, and to permit secure handling and maneuvering of the cover when applying it over the wound bed (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia to include a central protective liner, as taught by Bentley to protect a respective portion of adhesive of the strip prior to use of the strip, and to permit secure handling and maneuvering of the strip when applying it over the wound bed (as motivated by Bentley ¶[0060]).
Regarding Claim 8, Tolia is silent whether the first protective liner is removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer, wherein the second protective liner is removably adhered to a portion of the second adhesive surface of the adhering layer extending outward beyond the wound sealing layer, or wherein the central protective liner is removably adhered to the first adhesive surface of the wound sealing layer between the first and second protective liners.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, wherein the first protective liner is removably adhered to an outer edge portion of the first adhesive layer (Figs 3-4, 32A), wherein the second protective liner is removably adhered to an outer edge portion of the adhesive layer (Figs 3-4, 32B), and wherein the central protective liner is removably adhered to a central portion of the adhesive layer between the first and second protective liners (Figs 3-4, 32C) to protect a respective portion of adhesive of the cover prior to use of the cover, and to permit secure handling and maneuvering of the cover when applying it over the wound bed (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia so that the first protective liner is removably adhered to an outer edge portion of the first adhesive layer, wherein the second outer protective liner is removably adhered to an outer edge portion of the adhesive layer, and wherein the central protective liner is removably adhered to a central portion of the adhesive layer between the first and second outer protective liners, as taught by Bentley to protect a respective portion of adhesive of the strip prior to use of the strip, and to permit secure handling and maneuvering of the strip when applying it over the wound bed (as motivated by Bentley ¶[0060]). In combination, the first outer protective liner of Bentley would be removably adhered to an outer edge portion of the first adhesive surface of the wound sealing layer of Tolia, the second outer protective liner of Bentley would be removably adhered to a portion of the second adhesive surface of the adhering layer extending outward beyond the wound sealing layer (Fig 5 of Tolia shows that second adhesive surface 512 extends outward beyond layer 523 and thus either first or second outer protective liner could cover a portion of second adhesive surface 512 that extends beyond layer 523), and the central protective liner of Bentley would be removably adhered to the first adhesive surface of the wound sealing layer of Tolia.
Regarding Claim 9, Tolia is silent whether at least one of the first protective liner, the second protective liner, and the central protective liner comprises a release handle configured to remove the respective liner from the wound sealing layer or the adhering layer when actuated.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, wherein at least one of the first protective liner (Figs 3-4, 32A), the second protective liner (Figs 3-4, 32B), and the central protective liner (Figs 3-4, 32C) comprises a release handle configured to remove the respective liner from the wound sealing layer and/or the adhering layer when actuated (Figs 3-4 ¶[0060-0061], 32A comprises flange 58, 32B comprises flange 62, and 32C comprises flanges 60 and 64) to allow the user to grasp the liner portions to remove the liner from the cover and permit secure handling and maneuvering of the cover in order to place the cover over the wound (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia so that at least one of the first protective liner, the second protective liner, and the central protective liner comprises a release handle configured to remove the respective liner from the wound sealing layer and/or the adhering layer when actuated, as taught by Bentley to allow the user to grasp the liner portions to remove the liner from the strip and permit secure handling and maneuvering of the strip in order to place the strip over the wound (as motivated by Bentley ¶[0060]).
Regarding Claim 10, Tolia is silent whether the first protective liner, the second protective liner, and the central protective liner each comprise a width that extends a width of the fixation strip to removably adhere to the first adhesive surface of the wound sealing layer and a portion of the second adhesive surface of the adhering layer that extends outward beyond the wound sealing layer.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, the first protective liner, the second protective liner, and the central protective liner each comprise a width that extends a width of the fixation strip to removably adhere to the first adhesive surface of the wound sealing layer and a portion of the second adhesive surface of the adhering layer that extends outward beyond the wound sealing layer (Figs 3-4, liners 32A, 32B, and 32C all comprise a width that extends across the width of the entire structure 20, from front to back as depicted in Fig 4) to protect a respective portion of adhesive of the cover prior to use of the cover, and to permit secure handling and maneuvering of the cover when applying it over the wound bed (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia so that the first outer protective liner, the second outer protective liner, and the central protective liner each comprise a width that extends a width of the fixation strip to removably adhere to the first adhesive surface of the wound sealing layer and a portion of the second adhesive surface of the adhering layer that extends outward beyond the wound sealing layer, as taught by Bentley to protect a respective portion of adhesive of the strip prior to use of the strip, and to permit secure handling and maneuvering of the strip when applying it over the wound bed (as motivated by Bentley ¶[0060]).
Regarding Claim 12, Tolia discloses that the first adhesive comprises a silicone adhesive configured to adhere to the wound site or to skin surrounding the wound site (Fig 5 ¶[0066], adhesive 525 may comprise a silicone adhesive).
Regarding Claim 13, Tolia discloses that the second adhesive comprises an acrylic adhesive configured to adhere to a wound dressing (Fig 5 ¶[0077-0082], outer disk adhesive layer 512 may comprise an acrylate adhesive).
Claims 30, 31, 34-39 are rejected under 35 U.S.C. 103 as being unpatentable over Tolia (US 20170291020 A1) in view of Quintero (US 20200315858 A1), further in view of Bentley (US 20090105670 A1).
Regarding Claim 30, Tolia teaches an apparatus for sealing a wound site (Fig 5 ¶[0033] double disk system 500 comprises an outer disk layer with a pressure sensitive adhesive, and is thus capable of sealing a wound site), the apparatus comprising a fixation strip (Fig 5, 500), wherein the fixation strip (Fig 5, 500) includes a sealing layer configured to provide an airtight seal over a wound (Fig 5 ¶[0062] backing layer 511 may be made from impermeable materials and thus is fully capable of providing an airtight seal) includes an adhering layer (Fig 5, combination of adhesive surfaces of 525 and 512) and a protective liner removably adhered to the adhering layer (Fig 5, release liner 530).
Tolia is silent whether the apparatus comprises a sheet comprising a plurality of fixation strips and perforated portions, wherein each of the perforated portions is positioned between adjacent fixation strips, wherein each of the perforated portions comprises two perforated sections and a continuous cut section positioned between the two perforated sections, wherein the two perforated sections comprise a plurality of perforations separated by bridging portions that extend between adjacent fixation strips; a first outer protective liner, a second outer protective liner and a central protective liner each removably adhered to the adhering layer, wherein the continuous cut section extends along at least an entire length of the central protective liner.
However, Quintero teaches methods and devices for skin closure, thus from the same field of endeavor, wherein he apparatus comprises a sheet comprising a plurality of fixation strips and perforated portions (Fig 12-14 ¶[0068-0070], device 100 is a sheet comprising a plurality of individual wound closure devices 100a-e and perforated portions pa-pb and pc-pd), wherein each of the perforated portions is positioned between adjacent fixation strips (Figs 12-14 ¶[0068-0070], perforated portions pa-pb and pc-pd are positioned between adjacent wound closure device 100a-e), wherein each of the perforated portions comprises two perforated sections and a continuous cut section positioned between the two perforated sections (Figs 12-14 ¶[0068-0070], combination of perforated portions pa and pb comprises two perforated sections pa and pb with a continuous cut section 5 extending therebetween) , wherein the two perforated sections comprise a plurality of perforations separated by bridging portions that extend between adjacent fixation strips (Figs 12-14 ¶[0068-0070] perforated sections pa and pb each comprise a plurality of perforations separated by bridging portions 140 of liner assembly 120 and 130) to provide an array of devices that may be more suitable for the closure of smaller incisions (¶[0069]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single fixation strip of Tolia to comprise a sheet comprising a plurality of fixation strips and perforated portions, wherein each of the perforated portions is positioned between adjacent fixation strips, wherein each of the perforated portions comprises two perforated sections and a continuous cut section positioned between the two perforated sections, wherein the two perforated sections comprise a plurality of perforations separated by bridging portions that extend between adjacent fixation strips, as taught by Quintero to provide an array of devices that may be more suitable for the closure of smaller incisions (as motivated by Quintero ¶[0069]).
Tolia/Quintero is silent regarding a first outer protective liner, a second outer protective liner and a central protective liner each removably adhered to the adhering layer, wherein the continuous cut section extends along at least an entire length of the central protective liner.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, comprising a first outer protective liner (Figs 3-4, 32A), a second outer protective liner (Figs 3-4, 32B) and a central protective liner (Figs 3-4, 32C) to protect a respective portion of adhesive of the cover prior to use of the cover, and to permit secure handling and maneuvering of the cover when applying it over the wound bed (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia/Quintero to include a first outer protective liner, a second outer protective liner and a central protective liner, as taught by Bentley to protect a respective portion of adhesive of the strip prior to use of the strip, and to permit secure handling and maneuvering of the strip when applying it over the wound bed (as motivated by Bentley ¶[0060]). In combination, the continuous cut section taught by Quintero would extend along at least an entire length of the central protective liner taught by Bentley.
Regarding Claim 31, the combination of Tolia/Quintero/Bentley teaches the plurality of fixation strips as set forth above for claim 30.
Tolia further discloses that each fixation strip is configured for placement over an edge of a wound dressing (Fig 5, 500 comprises adhesive 512 on its outer edges and is thus fully capable of being placed over an edge of a wound dressing).
Regarding Claim 34, the combination of Tolia/Quintero/Bentley teaches the plurality of fixation strips as set forth above for claim 30.
Tolia further discloses that the adhering layer of each fixation strip comprises an adhesive surface (Fig 5, combination of adhesive surfaces of 525 and 512) comprises a silicone adhesive configured to adhere to the wound site or to skin surrounding the wound site (Fig 5 ¶[0066], adhesive 525 may comprise a silicone adhesive).
Regarding Claim 35, the combination of Tolia/Quintero/Bentley teaches the plurality of fixation strips as set forth above for claim 30.
Tolia further discloses that the adhering layer of each of the plurality of fixation strips comprises an adhesive surface (Fig 5, combination of adhesive surfaces of 525 and 512) comprises comprising an acrylic adhesive configured to adhere to a wound dressing (Fig 5 ¶[0077-0082], outer disk adhesive layer 512 may comprise an acrylate adhesive).
Regarding Claims 36 and 37, the combination of Tolia/Quintero/Bentley teaches the plurality of fixation strips as set forth above for claim 30.
Tolia/Quintero is silent whether the first outer protective liner of each of the plurality of fixation strips comprises a first release handle and the second outer protective liner of each of the plurality of fixation strips comprises a second release handle; wherein the central protective liner of each of the plurality of fixation strips is positioned over the first and second release handles.
However, Bentley teaches an adhesive wound cover film, thus from the same field of endeavor, the first outer protective liner of each of the plurality of fixation strips comprises a first release handle (Figs 3-4 ¶[0060] liner 32A comprises flange 58) and the second outer protective liner of each of the plurality of fixation strips comprises a second release handle (Figs 3-4 ¶[0060], liner 32B comprises flange 62); wherein the central protective liner of each of the plurality of fixation strips is positioned over the first and second release handles (Figs 3-4, central liner 32C is positioned over flanges 58 and 62) to allow the user to grasp the liner portions to remove the liner from the cover and permit secure handling and maneuvering of the cover in order to place the cover over the wound (¶[0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tolia/Quintero so that the first outer protective liner of each of the plurality of fixation strips comprises a first release handle and the second outer protective liner of each of the plurality of fixation strips comprises a second release handle; wherein the central protective liner of each of the plurality of fixation strips is positioned over the first and second release handles, as taught by Bentley to allow the user to grasp the liner portions to remove the liner from the strips and permit secure handling and maneuvering of the strips in order to place the strips over the wound (as motivated by Bentley ¶[0060]).
Regarding Claim 38, the combination of Tolia/Quintero/Bentley teaches the plurality of fixation strips as set forth above for claim 30.
Tolia further discloses that the fixation strip further comprises a wound sealing layer comprising a first adhesive a wound sealing layer comprising a first adhesive (Fig 5 ¶[0045] layer 521 comprises adhesive surface on which first adhesive 525 is disposed), wherein the adhering layer overlies and extends outward beyond the wound sealing layer (Fig 5, adhesive layer 512 extends outward beyond 521), and wherein the adhering layer comprises a second adhesive (Fig 5, adhesive layer 512 is a second adhesive).
Regarding Claim 39, Tolia further discloses that the first adhesive comprises a silicone adhesive (Fig 5 ¶[0066], adhesive 525 may comprise a silicone adhesive) and the second adhesive comprises an acrylic adhesive (Fig 5 ¶[0077-0082], outer disk adhesive layer 512 may comprise an acrylate adhesive).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781