DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 9 June 2026. Claims 1, 3, and 5 have been amended. Claim 2 has been cancelled. Claims 7-20 remain withdrawn. Claims 1 and 3-6 are currently pending and under examination.
This Application is a continuation of International Application PCT/US2021/049671, filed September 9, 2021, which claims benefit of priority to U.S. Provisional Application No. 63/077029, filed September 11, 2020.
Withdrawal of Rejections:
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Wikipedia, is withdrawn.
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Atala et al., is withdrawn.
New Rejections Necessitated by Amendment:
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.
Claims 1 and 3-6 are 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 1 as amended recites an outer-facing epidermal portion and an inner-facing dermal portion. This claim is indefinite, because it is unclear what an epidermal or dermal “portion” is intended to include or exclude; there is no guidance in the specification regarding these terms. For example, it is unclear if a single cell is intended to constitute a “portion,” or if/what certain percentage of a full dermal or epidermal layer meet this limitation.
Claims 3-6 are included in this rejection as they depend from above rejected claim 1, and alone do not remedy the noted deficiencies.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinand (Degloving Injuries of Upper Extremity: A Strategy with Full Thickness Skin Mesh, World Journal of Plastic Surgery, Case Report, Vol. 7, No. 3, (Sept. 2018), pp. 372-376).
With regard to claim 1, Weinand teaches a meshed full thickness skin graft (Abs.; Fig. 2), wherein a full thickness skin graft is a skin substitute comprising an outer-facing epidermal portion and an inner-facing dermal portion. The full thickness skin graft is configured to conform to the forearm of the subject to repair a degloving injury and is wrapped around the forearm completely to cover the underlying tissue (Abs.; Fig. 2), which is graft having at least one surface with an enclosed geometry, and circling back on itself so as to enclose the forearm.
With regard to claims 3-6, Weinand teaches a full thickness skin graft (Fig. 2), wherein a full thickness skin graft comprises epidermal cells, including keratinocytes, and dermal cells, including fibroblasts (see Art of Record: Ramsey et al., p. 2, Anatomy and Physiology, Para. 1).
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
Art of Record:
Ramsey et al., Full-Thickness Skin Grafts, StatPearls, NCBI Bookshelf, (Jan. 2026), pp. 1-8; Available online at: www.ncbi.nlm.nih.gov/sites/books/NBK532875/ (a full thickness skin graft comprises epidermal cells, including keratinocytes, and dermal cells, including fibroblasts).
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.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653