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 Amendment
This office action is responsive to the amendment filed on 03/23/2026. As directed by the amendment: claims 1 has been amended and claims 2, 7, 8, 15, and 21-30 have been cancelled. Thus, claims 1, 3-6, 9-14, and 16-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues Gurtner fails to teach the method reduces contracture of the applied STSG as compared to the application of a STSG in the absence of a mechanotransduction blocker because Gurtner “only discusses applying a FAK inhibitor to a wound as part of an unspecified skin graft in a couple of isolated instances (i.e., paragraphs [0048] and [0068] of Gurtner) but provides no teaching or suggestion that contracture of the unspecified skin graft during healing may be affected by the FAK inhibitor, let alone a particular teaching or suggestion that contracture of a STSG during healing may be affected by the FAK inhibitor”. The Office respectfully disagrees. Gurtner discloses that the formation of scars are reduced when FAK inhibitor is applied to a wound (see [0077]). Gurtner further defines “scar” as used therein to include contracture (see [0072]), thus Gurtner discloses FAK inhibitors reduce contracture formation. Gurtner also discloses that FAK inhibitors are used as part of skin grafts (see [0048] and [0068]). Since FAK inhibitors are used as part of skin grafts and reduce contracture formation, Gurtner discloses the method reduces contracture of the applied skin graft as compared to the application of a skin graft in the absence of a mechanotransduction blocker. Gurtner is then modified by Basile to have the skin graft be a split thickness skin graft. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, The Office maintains that Gurtner as modified teaches the method reduces contracture of the applied STSG as compared to the application of a STSG in the absence of a mechanotransduction blocker.
Applicant further argues that the method of claim 1 achieves unpredictable / unexpected results because “The present inventors have surprisingly discovered that applying a STSG skin graft to a wound in combination with a mechanotransduction blocker to treat the wound of the subject reduces contracture of the applied STSG as compared to the application of a STSG in the absence of a mechanotransduction blocker”. The Office respectfully disagrees. MPEP 716.02 sets forth that evidence must be relied upon to show unexpected results and that the burden of proof rely upon the applicant. While applicant has alleged that the claim 1 achieves unpredictable / unexpected results, the only evidence submitted to support his conclusion is the use of a STSG with a FAKI and a SPTSG without a FAKI. As explained above, Gurtner discloses using FAKIs with skin grafts to reduce scar formation, so applicant’s findings are consistent with that of Gurtner and not unexpected in view of the teachings of Gurtner. As a result this evidence has not met the burden of proof to show unexpected results. Should the applicant wish to submit additional evidence, it is recommend that applicant compare the results achieved by the graft of Gurtner with their invention. Therefore, The Office maintains that Gurtner as modified teaches the method reduces contracture of the applied STSG as compared to the application of a STSG in the absence of a mechanotransduction blocker.
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.
Claims 1, 3-6, 9-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gurtner et al. (WO 2019/222520 A1) in view of Basile et al. (US 2014/0205561 A1).
Regarding claim 1 Gurtner discloses a method of treating a wound of a subject, the method comprising: applying a skin graft (see fig. 14 and [0048]) to the wound in combination with a mechanotransduction blocker (FAKI hydrogel scaffold, see [0048] and [0035]) to treat the wound of the subject (see [0049]), wherein the mechanotransduction blocker comprises a focal adhesion kinase inhibitor (see [0048]), and wherein the method reduces contracture of the applied STSG as compared to the application of a STSG in the absence of a mechanotransduction blocker (see [0072] and [0018]; the graft of Gurtner comprises a mechanotransduction blocker).
Gurtner further discloses the graft is used to treat a burn wound (see [0039] and [0049]) but is silent regarding the skin graft is a split-thickness skin graft.
However Basile, in the same filed of endeavor, teaches that split-thickness skin grafts are used to treat burn wounds (see [0048]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective failing date of the claimed invention, to modify Gurtner to have the graft be a split-thickness skin graft as taught by Basile, for the purpose of processed through a meshing apparatus and expanded up to nine times to cover large areas (see Basile [0048]).
Regarding claim 3, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the wound is a deep injury wound (see [0041] and [0049]).
Regarding claim 4, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 3. Gurtner further discloses the deep injury wound is a burn wound (see [0039] and [0049]).
Regarding claim 5, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 3. Gurtner further discloses the deep injury wound is a traumatic wound (see [0049]).
Regarding claim 6, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the skin graft is applied to the wound before the mechanotransduction blocker (see fig. 14, the bottom layer is skin graft without a mechanotransduction blocker).
Regarding claim 9, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the mechanotransduction blocker is administered in a sustained release formulation to the wound (see [0014]).
Regarding claim 10, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Gurtner further discloses the sustained release formulation comprises a gel formulation (hydrogel, see [0035]).
Regarding claim 11, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Gurtner further discloses the gel formulation comprises a hydrogel (see [0035]).
Regarding claim 12, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Gurtner further discloses hydrogel comprises a biodegradable pullulan-based hydrogel (see [0035]).
Regarding claim 13, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the method promotes healing of the wound (see [0010]).
Regarding claim 14, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the method reduces fibrosis as compared to the application of a skin graft in the absence of a mechanotransduction blocker (see [0007]; the graft of Gurtner comprises a mechanotransduction blocker).
Regarding claim 16, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the method mitigates scar formation as compared to the application of a skin graft in the absence of a mechanotransduction blocker (see [0018]; the graft of Gurtner comprises a mechanotransduction blocker).
Regarding claim 17, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the method restores collagen architecture as compared to the application of a skin graft in the absence of a mechanotransduction blocker (see [0047]; the graft of Gurtner comprises a mechanotransduction blocker).
Regarding claim 18, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the method improves graft biomechanical properties as compared to the application of a skin graft in the absence of a mechanotransduction blocker (see [0104]; the graft of Gurtner comprises a mechanotransduction blocker).
Regarding claim 19, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gurtner further discloses the subject is mammal (see [0049]).
Regarding claim 20, Gurtner as modified discloses the claimed invention substantially as claimed, as set forth above for claim 19. Gurtner further discloses the mammal is a human (see [0049]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mechanotransduction in Wound Healing and Fibrosis which teaches that poor wound healing have been shown to have atypical levels of Focal adhesion kinase; Controlled Delivery of a Focal Adhesion Kinase Inhibitor Results in Accelerated Wound Closure with Decreased Scar Formation.
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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771