DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “the pressing step”. It is unclear if this is referencing the step of “pressing said second pressure sensitive adhesive” or “pressing a therapeutic device against said first pressure sensitive adhesive” recited in claim 5. For the sake of examination, the limitation will be interpreted as reciting “the pressing the therapeutic device step”.
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.
Claims 1, 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 2017/0189237) in view of Luckemeyer (US 2020/0246190).
Regarding Claim 1, Locke disclose a wound closure system (100, Fig 1) comprising: a porous mesh (106, Fig 1) having a top surface and a bottom surface; a removable first liner (120, Fig 3) covering said top surface; a second pressure sensitive adhesive (116, Fig 3) applied to the bottom surface of said porous mesh (Para 0061); a removable second liner (126, Fig 3) covering said second pressure sensitive adhesive.
Locke is silent regarding a first pressure sensitive adhesive applied to the top surface of said porous mesh and said second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive.
Luckemeyer teaches a porous mesh (134, Fig 4) having a top surface and a bottom surface; a first pressure sensitive adhesive (136, Fig 4) applied to the top surface of said porous mesh (Para 0061); a removable first liner (150, Fig 4) covering said first pressure sensitive adhesive; a second pressure sensitive adhesive (138, Fig 4) applied to the bottom surface of said porous mesh; a removable second liner (152, Fig 4) covering said second pressure sensitive adhesive; said second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive (Para 0055).
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 porous mesh to have a pressure sensitive adhesive on a top surface and have the second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive as taught by Luckemeyer in order to have a porous mesh with a selectable adhesive configuration such that an adhesive type can be selected based on the needs of the tissue without requiring multiple devices (Para 0054-0055).
Regarding Claim 3, the modified invention of Locke and Luckemeyer discloses said porous mesh is flat, elongated along a longitudinal axis, and has a plurality of openings (118, Fig 4 -Locke) extending between the top and bottom surfaces thereof (Sees Fig 1 and 4; Para 0066 -Locke).
Regarding Claim 4, the modified invention of Locke and Luckemeyer discloses said removable first liner is configured to be peeled away from the top surface of said porous mesh for exposing said first pressure sensitive adhesive, and wherein said removable second liner is configured to be peeled away from the bottom surface of said porous mesh for exposing said second pressure sensitive adhesive (Para 0066 -Luckemeyer; Para 0072-0073 -Locke).
Claims 2, 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 2017/0189237) in view of Luckemeyer (US 2020/0246190) and further in view of Ou (US 11,712,229).
Regarding Claim 2, the modified invention of Locke and Luckemeyer discloses all of the elements of the invention as discussed above, however, is silent regarding a cross-linking or polymerization accelerator or catalyst disposed in or on said porous mesh.
Ou teaches applying a cross-linking catalyst on a porous mesh (Col 3, lines 46-53).
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 system disclosed by Locke and Luckemeyer to include a cross-linking catalyst applied to the porous mesh in order to reinforce and ensure a seal over the wound (Col 3, lines 46-53).
Regarding Claim 5, the modified invention of Locke and Luckemeyer discloses a method of using said wound closure system as claimed in claim 1 (See rejection of claim 1 above), comprising: peeling said removable second liner away from the bottom surface of said porous mesh to expose said second pressure sensitive adhesive applied to the bottom surface of said porous mesh; pressing said second pressure sensitive adhesive applied to the bottom surface of said porous mesh against skin of a patient to approximate opposing edges of a wound (Para 0035; 0073 -Locke); peeling said removable first liner away from the top surface of said porous mesh to expose said first pressure sensitive adhesive applied to the top surface of said porous mesh (Para 0067 -Luckemeyer); pressing a therapeutic device (110,112, 104, Fig 1 -Locke) against said first pressure sensitive adhesive to secure said therapeutic device over the top surface of said porous mesh (Para 0037, 0075 -Locke)
The modified invention of Locke and Luckemeyer is silent regarding applying a liquid adhesive over the top surface of said porous mesh and at least a portion of said therapeutic device; allowing said liquid adhesive to cure for binding said porous mesh to the skin and binding said therapeutic device to said porous mesh.
Ou teaches applying a liquid adhesive and cross-linking catalyst over the top surface of said porous mesh; allowing said liquid adhesive to cure for binding said porous mesh to the skin (Col 3, lines 46-53).
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 system disclosed by Locke and Luckemeyer to include a cross-linking catalyst applied to the porous mesh in order to reinforce and ensure a seal over the wound (Col 3, lines 46-53). Examiner notes that while Ou does not mention a therapeutic device, the therapeutic device of the modified invention of Locke and Luckemeyer is on the top surface and thus the liquid adhesive would be provided on at least a portion of said therapeutic device as it is applied to the entirety of the porous mesh.
Regarding Claim 6, the modified invention of Locke, Luckemeyer, and Ou discloses the pressing step comprises aligning said therapeutic device with the wound (Para 0075, 0035 -Locke).
Regarding Claim 7, the modified invention of Locke, Luckemeyer, and Ou discloses using said therapeutic device for draining exudate from the wound (Para 0046 -Locke) or infusing saline or medication into the wound.
Regarding Claim 8, the modified invention of Locke, Luckemeyer, and Ou discloses said liquid adhesive comprises a rapidly polymerizable or cross-linkable liquid adhesive (Col 3, lines 46-53 -Ou).
Regarding Claim 9, the modified invention of Locke, Luckemeyer, and Ou discloses said therapeutic device is selected from the group of devices consisting of negative pressure wound therapy devices , negative pressure pumps, fluid suction devices, elongated tubes including drainage tubes and infusion tubes, elongated tubes having first and second mesh wings extending along lateral sides thereof, cannulas, and wound monitoring sensors (Para 0043-0045 -Locke).
Regarding Claim 10, Locke discloses a kit comprising: a wound closure (100, Fig 1) system including a porous mesh (106, Fig 1) having a top surface and a bottom surface, a removable first liner covering (120, Fig 3) said top surface, a second pressure sensitive adhesive (116, Fig 3) applied to the bottom surface of said porous mesh (Para 0061), and a removable second liner (126, Fig 3) covering said second pressure sensitive adhesive.
Locke is silent regarding a first pressure sensitive adhesive applied to the top surface of said porous mesh and said second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive; and a rapidly polymerizable liquid adhesive disposed within a dispenser container.
Luckemeyer teaches a porous mesh (134, Fig 4) having a top surface and a bottom surface; a first pressure sensitive adhesive (136, Fig 4) applied to the top surface of said porous mesh (Para 0061); a removable first liner (150, Fig 4) covering said first pressure sensitive adhesive; a second pressure sensitive adhesive (138, Fig 4) applied to the bottom surface of said porous mesh; a removable second liner (152, Fig 4) covering said second pressure sensitive adhesive; said second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive (Para 0055).
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 porous mesh to have a pressure sensitive adhesive on a top surface and have the second pressure sensitive adhesive being stronger or denser than said first pressure sensitive adhesive as taught by Luckemeyer in order to have a porous mesh with a selectable adhesive configuration such that an adhesive type can be selected based on the needs of the tissue without requiring multiple devices (Para 0054-0055).
the modified invention of Locke and Luckemeyer discloses all of the elements of the invention as discussed above, however, is silent regarding a rapidly polymerizable liquid adhesive disposed within a dispenser container.
Ou teaches a rapidly polymerizable liquid adhesive disposed within a dispenser container (100, Fig 1) for binding said porous mesh to the skin (Col 3, lines 46-53).
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 system disclosed by Locke and Luckemeyer to include a cross-linking catalyst applied to the porous mesh in order to reinforce and ensure a seal over the wound (Col 3, lines 46-53).
Regarding Claim 11, the modified invention of Locke, Luckemeyer, and Ou discloses one or more therapeutic devices (110,112, 104, Fig 1 -Locke) configured to be secured over the top surface of said porous mesh (Para 0037, 0075 -Locke).
Regarding Claim 12, the modified invention of Locke, Luckemeyer, and Ou discloses said one or more therapeutic devices are selected from the group of devices consisting of negative pressure wound therapy devices, negative pressure pumps, fluid suction devices, elongated tubes including drainage tubes and infusion tubes, elongated tubes having first and second mesh wings extending along lateral sides thereof, cannulas, and wound monitoring sensors (Para 0043-0045 -Locke).
Regarding Claim 13, the modified invention of Locke, Luckemeyer, and Ou discloses a cross-linking or polymerization accelerator or catalyst disposed in or on said porous mesh (Col 3, lines 46-53 -Ou).
Claims 14, 16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 2017/0189237) in view of Ou (US 11,712,229).
Regarding Claim 14, Locke disclose a wound closure system (100, Fig 1) comprising: a porous mesh (106, Fig 1) having a top surface and a bottom surface; the bottom surface of said porous mesh being adhered to skin for approximating opposing edges of a wound (Para 0035, 0062); a therapeutic device (110,112, 104, Fig 1 -Locke) including an elongated tube (112, Fig 1) secured to the top surface of said porous mesh and overlying the wound, said elongated tube being configured for draining exudate from the wound (Para 0046, Para 0075).
Lock is silent regarding a liquid adhesive covering the top surface of said porous mesh and at least a portion of said elongated tube.
Ou teaches applying a liquid adhesive and cross-linking catalyst over the top surface of said porous mesh for binding said porous mesh to the skin (Col 3, lines 46-53).
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 system disclosed by Locke to include a liquid adhesive and cross-linking catalyst applied to the porous mesh in order to reinforce and ensure a seal over the wound (Col 3, lines 46-53). Examiner notes that while Ou does not mention a therapeutic device, the therapeutic device of Locke is on the top surface and thus the liquid adhesive would be provided on at least a portion of said therapeutic device as it is applied to the entirety of the porous mesh.
Regarding Claim 16, the modified invention of Locke and Ou discloses said elongated tube (112, Fig 1 -Locke) comprises a first elongated conduit that is coupled with a vacuum or negative pressure pump for draining the exudate from the wound (Para 0046, Para 0075 -Locke).
Regarding Claim 18, the modified invention of Locke and Ou discloses said liquid adhesive is a topical skin adhesive or a rapidly polymerizable adhesive that forms an air-tight seal around the wound (Col 3, lines 46-53 -Ou).
Regarding Claim 19, the modified invention of Locke and Ou discloses the air-tight seal formed by said liquid adhesive is waterproof (Col 3, lines 46-53 -Ou) or comprises an antimicrobial barrier.
Regarding Claim 20, a cross-linking or polymerization accelerator or catalyst (“catalyst”) disposed in or on said porous mesh (Col 3, lines 46-53 -Ou).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 2017/0189237) in view of Ou (US 11,712,229) and further in view of Rice (US 2022/0088286) and further in view of Zurovcik (US 2014/0031735).
Regarding Claim 15, the modified invention of Locke and Ou discloses all of the elements of the invention as discussed above, however, is silent regarding said therapeutic device further comprising first and second mesh wings secured to said elongated tube and extending along respective lateral sides of said elongated tube, wherein said liquid adhesive covers said first and second mesh wings for securing said therapeutic device to the top surface of said porous mesh.
Rice teaches an analogous therapeutic device comprising first and second mesh wings (1940, 1945, Fig 19) secured to said elongated tube (250, Fig 20) and extending along respective lateral sides of said elongated tube (See Figs 19-20) (Para 0107).
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 dressing interface of the therapeutic device to have a first and second mesh wing (porous foam or cell porous textile) as taught by Rice order in order to support fluid paths under pressure and prevent the enclosed spaces from collapsing (Para 0107).
The modified invention of Locke, Ou, and Rice disclose all of the elements of the innovation as discussed above, however, is silent regarding said liquid adhesive covers said first and second mesh wings for securing said therapeutic device to the top surface of said porous mesh.
Zurovcik teaches an analogous device wherein a liquid adhesive covers said dressing interface for securing said therapeutic device to the top surface of said porous mesh (Para 0139).
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 to include the liquid adhesive or sealant on the dressing interface (which includes the first and second mesh wings in the modified invention) in order to form an occlusive seal and prevent any potential air leaks between the tube to dressing interfaces (Para 0139-0140).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 2017/0189237) in view of Ou (US 11,712,229) and further in view of Dutta (US 2021/013746).
Regarding Claim 17, the modified invention of Locke and Ou discloses all of the elements of the invention as discussed above, however, is silent regarding said elongated tube comprises a second elongated conduit that is coupled with a positive pressure pump configured to force saline or medication into said elongated tube for infusing the wound with the saline or the medication.
Dutta teaches an elongated tube (106, Fig 6c) comprising a second elongated conduit that is coupled with a positive pressure pump configured to force saline or medication into said elongated tube for infusing the wound with the saline or the medication (Para 0022, 0062).
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 elongated tube to comprise a second conduit for the delivery of saline or medication as taught by Dutta in order to enhance wider range of biomechanism favorable for wound healing (Para 0022).
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783