DETAILED ACTION
In Applicant’s Response filed 5/13/26, Applicant has amended claims 1-4 and added new claim 5. Currently, claims 1-5 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/13/26 has been entered.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Mofid (US 11311641) in view of Brothers (US 2005/0245855) and further in view of Smith (US 6238692).
With respect to claim 1, Mofid discloses a surgical procedure performed on separated tissue (method of applying a wound dressing to a cut wound that does not include stitches or staples – see col 2 lines 23-24, col 4 lines 39-40, col 7 lines 1-3, 14-16, 51-55; tissue is interpreted as being separated because the cut in the skin is not closed by stitches or staples, thereby leaving at least some amount of separation between tissue on each side of the cut), comprising:
applying a wound dressing to the separated tissue (item 1 in col 7); and
applying a substance over the wound dressing (sealing adhesive; item 16 in col 7) on the area of separation of the separated tissue (the sealing adhesive is applied over the dressing on the cut wound) resulting in a dressing fixture on the area of the separation (the sealing adhesive is applied over the dressing and provides waterproofing so that the dressing does not fall off during showering or swimming – col 6 lines 19-30; thus the sealing adhesive is interpreted as assisting in fixing the dressing to the skin by preventing the dressing from being removed when contacted by water) such that the separated tissue remains separated during healing of the separated tissue (the cut wound is interpreted as being separated tissue as described above and remains separated since there are no stitches or staples to hold the side edges of the wound closed).
Mofid does not, however, explicitly disclose that the substance is malleable during application or that the dressing fixture hardens after application.
Brothers, however, teaches a method that involves applying a cyanoacrylate in liquid form to a wound site wherein the cyanoacrylate quickly sets after it is applied (para [0016]; the liquid state during application is interpreted as being malleable since the liquid form is capable of being manipulated into various shapes). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a cyanoacrylate material that is malleable during application and hardens after application, as taught by Brothers, as the cyanoacrylate adhesive used in the method of Mofid, in order to allow for customization of the shape/size of the structure to more closely match the contours of the skin at a wound site while also providing adequate protection of the wound once hardened to promote healing.
Mofid also does not explicitly disclose that the dressing fixture that hardens prevents reattachment of the separated tissue during the healing.
Brothers, however, also teaches that the hardenable adhesive material will quickly set after it is applied to the wound site (para [0016]) and that the adhesive can be applied to wounds located both internally and externally (para [0017]) and provides extra tensile strength to high-tension wounds to prevent a high rate of reepithelialization that causes severe scars (para [0017]). Application of the hardenable adhesive material internally to a wound such that it sets quickly is interpreted as inherently causing the wound to be held or maintained in a configuration where the edges of the wound are separated and are prevented from reattaching since the material, once hardened, will prevent separated tissues from moving towards each other for wound closure. Furthermore, this will prevent a high rate of reepithelialization since new skin cannot form rapidly to cover and seal the wound when tissues are maintained in a separated state. Thus, 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 procedure of Mofid in view of Brothers to apply the hardenable substance internally to a wound as taught by Brothers such that the substance that hardens rapidly prevents reattachment of the separated tissue during healing of the wound in order to prevent a high rate of reepithelialization that causes severe scars (Brothers para [0017]).
Mofid also does not explicitly disclose the step of applying the wound dressing “inside an area of separation of the separated tissue”.
Smith, however, teaches forming a tissue dressing that is applied inside an area of separation of separated tissue (as shown in fig 2, bioadhesive liquid 13 is applied inside an area where tissue (flesh 12) is separated wherein the bioadhesive polymerizes and bonds to tissue to form a protective and resilient layer and the resulting product of the process is a tissue dressing that protects the afflicted tissue during the healing process - col 3 lines 50-63). Thus, 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 method of Mofid in view of Brothers so that the step of applying the wound dressing includes application “inside an area of separation of the separated tissue”, as taught by Smith, in order to provide a protective and resilient layer that protects the afflicted tissue inside the separated area during healing.
Claim(s) 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mofid (US 11311641) in view of Brothers (US 2005/0245855) and Smith (US 6238692) and further in view of Silvetti (US 4778679).
With respect to claim 2, Mofid in view of Brothers and further in view of Smith discloses the procedure substantially as claimed (see rejection of claim 1) but does not disclose that the wound dressing includes sodium ascorbate powder.
Silvetti, however, teaches compositions for treatment of wounds wherein ascorbate salts are provided in a dressing for activation of tissue enzymes for collagen formation (col 2 lines 24-29). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added sodium ascorbate powder to the substance in the method of Mofid in view of Brothers and further in view of Smith in order to encourage collagen formation for improved healing.
With respect to claim 3, Mofid in view of Brothers and Smith and further in view of Silvetti discloses the procedure substantially as claimed (see rejection of claim 2) and Mofid also discloses that the substance is a cyanoacrylate adhesive (item 17 in col 7).
With respect to claims 4-5, Mofid in view of Brothers and Smith and further in view of Silvetti discloses the procedure substantially as claimed (see rejection of claim 3) and Brothers also teaches that the sodium ascorbate powder and the cyanoacrylate adhesive over the sodium ascorbate powder cause the dressing fixture to become substantially non-adhesive dressing fixture that hardens within five minutes because the cyanoacrylate becomes substantially non-adhesive within five minutes (the cyanoacrylate takes 10-15 seconds to properly set and polymerize before an additional layer can be applied – para [0019]; the cyanoacrylate adhesive is applied over the dressing, wherein the dressing includes sodium ascorbate as described in the rejection of claims 1-2 – thus, when the adhesive hardens and thus renders the structure “non-adhesive”, the entire structure that the adhesive covers inherently will also be caused to harden). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a cyanoacrylate that becomes substantially non-adhesive within five minutes so that the sodium ascorbate powder and the cyanoacrylate adhesive over the sodium ascorbate powder cause the dressing fixture to become substantially non-adhesive dressing fixture that hardens within five minutes, as taught by Brothers, in order to provide a quick/fast means for providing protection to a wound to minimize exposure to the environment and so that a patient is free to move about and resume normal activities in a short amount of time.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 5/13/26 have been fully considered as follows:
With respect to the claim rejections under 35 USC 103, Applicant’s arguments on pages 3-6 have been fully considered but are not persuasive.
Specifically, the Office has noted Applicant’s arguments on pages 3-4 that applying the present claim 1 to Mofid would frustrate the purpose of Mofid because Mofid’s intent or purpose is to close separated tissue wherein the present claim 1 emphasizes maintaining separation of the tissue. The Office is not persuaded by these arguments, however, because although the device of Mofid may be capable of being used to prevent separation of a wound that has been previously closed (such as by sutures), there is no explicit disclosure of such steps being required in the procedure disclosed in Mofid. Edges of a wound that are not held together (i.e. such as by sutures) or otherwise maintained in touching relation with each other inherently have at least some amount of separation between tissues on each side of the wound. Thus, the failure in Mofid to specifically disclose or require closure of the wound such that opposing sides are held in contact with each other has been interpreted to mean that the dressing/adhesive is applied to a wound that has at least some amount of separation between tissues on each side of the wound. For at least this reason, the Office is not persuaded by Applicant’s arguments and therefore maintains that the prior art of record reads on the claims substantially as recited in the present application.
The Office has also noted Applicant’s arguments on pages 5-6 but these arguments are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Conclusion
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
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