DETAILED ACTION
In Applicant’s Response filed 11/10/25, Applicant has amended claims 1-2. Currently, claims 1-4 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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mofid (US 11311641) in view of Brothers (US 2005/0245855).
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 an area of the separated tissue desired to remain separated during healing (the sealing adhesive is applied over the dressing on the cut wound wherein 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 sealing adhesive is malleable during application or that it 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 substance that hardens prevents retattachment of the separated tissue during healing of the wound.
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 retattachment 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]).
With respect to claim 2, Mofid in view of Brothers discloses the procedure substantially as claimed (see rejection of claim 1) and Mofid also discloses the substance provides a dressing fixture (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).
With respect to claim 3, Mofid in view of Brothers discloses the procedure substantially as claimed (see rejection of claim 2) and Mofid also discloses that the dressing fixture is a cyanoacrylate adhesive (item 17 in col 7).
With respect to claim 4, Mofid in view of Brothers discloses the procedure substantially as claimed (see rejection of claim 3) and Brothers also teaches that 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]). 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, as taught by Brothers, as the cyanoacrylate used in the method of Mofid, 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 11/10/25 have been fully considered as follows:
With respect to the objections to the claims, Applicant’s amendments to claim 2 have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
With respect to the claim rejections under 35 USC 103, Applicant’s arguments on pages 3-4 have been fully considered but are not persuasive.
Specifically, the Office has noted Applicant’s argument that there is nothing in the disclosure in Mofid to support the interpretation that "the cut wound ... remains separated since there are no stitches or staples to hold the side edges of the wound closed" as asserted in the Office Action. Applicant further argues that “Mofid repeatedly states that the disclosure is directed to "scaffoldings including pressure - sensitive adhesives, which can be easily affixed to wounds to prevent wound/incisional separation”…” and that “Mofid only describes the wound dressing being used to close wounds, e.g., "a strong and flexible dressing such that, in some cases, stitching may not be required"…”. 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.
Regarding Applicant's Request for an Interview on page 4 of the Response, Applicant's request has been noted however an interview has not been granted at this time for at least the following reasons: Under MPEP 713.01(IV), “An interview should normally be arranged for in advance, as by letter, facsimile, electronic mail, or telephone call, in order to insure that the primary examiner and/or the examiner in charge of the application will be available. When applicant is initiating a request for an interview, an "Applicant Initiated interview Request" form (PTOL-413A) should be submitted to the examiner prior to the interview in order to permit the examiner to prepare in advance for the interview and to focus on the issues to be discussed. This form should identify the participants of the interview, the proposed date of the interview, whether the interview will be personal, telephonic, instant message system or video conference, and should include a brief description of the issues to be discussed”. Although it is true that the fact that applicant does not submit an "Applicant Initiated interview Request" form is not, by itself, grounds for the examiner to deny a request for an interview (MPEP 713.01), in the present application, Applicant has not only failed to request an interview using a PTOL-413 form but also has failed to specifically request that an interview be scheduled via separate letter, facsimile, electronic mail, or telephone call to insure that the Examiner will be available on a given date/time. Furthermore, Applicant has not provided any description of the issues which Applicant wants to discuss or the specific participants for the requested interview. Applicant has requested that the Examiner contact Applicant “prior to issuing another Office Action if additional relevant prior art is cited” however, as noted in the claim rejections presented above, the previously cited prior art of record has been interpreted as reading on the amended claims and no new prior art references have been cited at this time. Therefore, for at least this reason, Applicant's request for an interview has not been granted prior to this Action. However, Examiner encourages Applicant to contact the Examiner to schedule an interview, if desired, to discuss this Action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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, Rachael Bredefeld can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786