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 .
Status of the Claims
Claims 13- 27 are currently pending.
Claim 13, 16, and 17 are amended.
Claims 20-23 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 13-19 and 24-27 have been considered on the merits.
Withdrawn Rejections
The rejections made under 35 U.S.C. § 101 are withdrawn in light of the amendments submitted on 10/02/2025.
New and Maintained Rejections
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-19 and 24-27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wu et al (US20150104432A1).
With regards to claim 13, Wu teaches a three dimensional multilayered engineered human skin composition as required by claims 13 and 26 (abstract). Wu teaches that there is an epidermal layer comprising keratinocytes as required by claim 13 and 26 ([0019]), and further that all cell types used in the skin construct can be made from induced pluripotent stem cells as required by claim 13 and 26 ([0047]). Wu teaches that there is a layer of dermal fibroblasts as required by claim 13 and 26 ([0019]/fig. 1), and further that all cell types used in the skin construct can be made from induced pluripotent stem cells ([0047]). Wu teaches that the dermal and epidermal layer are in direct contact as required by claim 13 and 26 (figure 1 and [0019]). Wu teaches that the skin construct contains a functional hair follicle which is formed though dermal papilla cells as required by claim 13 ([0024]-[0028]). Wu teaches that a biodegradable or synthetic substrate can be used as a support scaffold, such as and not limited to collagen, gelatin, silicon, or PET, as required by claims 13, 16-18, and 26 ([0053]). Wu teaches that the engineered skin composition contains mesenchymal stem cells ([0047]), dermal sheath cells ([0024]), and follicular epidermal stem cells ([0013]/[0045]/[0024]) as required by claims 14 and 24-27. Wu teaches that the skin construct contains functional sebaceous glands and nerves as required by claim 15 ([0058]/[0061]). Wu teaches that the skin construct is capable of viable transplantation and engraftment to a human subject as required by claim 19 ([0058]-[0060]).
Therefore, Wu anticipates the claims.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 6 para 3) that Wu does not teach an in vitro culture rather a mixed slurry of dermal and epidermal cells which are grafted into a mouse.
In response to this argument, Wu does teach an embodiment of the invention that requires a mixed slurry of the cells be grafted into a mouse. However, Wu teaches that the isolated cells can also be cultured, and that an example cell culturing method is provided in Fig. 4 ([0052]). Fig. 4 provides a method of culturing that does not require that the cells be grafted into a mouse, in comparison Fig. 3 provides the method of culturing including grafting the cells into a recipient (mouse).
Therefore, the argument is not found persuasive.
Applicant argues (Remarks, pg. 6, para 4) that Wu does not teach that the dermal papillae are pluripotent stem cell derived dermal papillae, rather “Wu suggests that multipotent dermal cells could be derived from an induced pluripotent stem cell (iPSC) source ([0047]), this is not demonstrated in Wu” (Remarks, pg. 6, para 4).
In response to this argument, Wu states that the “skin organ 110 generation method may use cell for the development of iPSC strains, and differentiate iPSCs into dermal papilla cells” ([0061]). Thus, Wu describes the claimed limitation. The MPEP states at 2152.02(b) that “While the conditions for patentability of AIA 35 U.S.C. 112(a) require a written description of the claimed invention that would have enabled a person skilled in the art to make as well as use the invention, the prior art provisions of AIA 35 U.S.C. 102(a)(1) and (a)(2) require only that the claimed invention is "described" in a prior art document (patent, published patent application, or printed publication).”
Therefore, the argument is not found persuasive.
Applicant argues (Remarks, last para pg. 6 spanning para 3 of pg. 7) that the disclosure of Wu is not enabled because they did not demonstrate that iPSC derived dermal papilla were able to produce hair follicles and that Gnedeva, published after Wu, shows low frequency of 1 out of 50 transplants being able to form hairs.
The argument is not found persuasive. Wu states that the “skin organ 110 generation method may use cell for the development of iPSC strains, and differentiate iPSCs into dermal papilla cells” ([0061]). Thus, Wu describes the claimed limitation. The MPEP states at 2152.02(b) that “While the conditions for patentability of AIA 35 U.S.C. 112(a) require a written description of the claimed invention that would have enabled a person skilled in the art to make as well as use the invention, the prior art provisions of AIA 35 U.S.C. 102(a)(1) and (a)(2) require only that the claimed invention is "described" in a prior art document (patent, published patent application, or printed publication).”
Therefore, the argument is not found persuasive.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632