CTNF 18/423,327 CTNF 101691 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Status Claims 1 – 18 are pending. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1, 2, 4, 5, 6, 8 and 10 – 15 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Helgason et al. (U.S. 2017/0306428 A1; hereinafter Helgason) . Regarding claims 1, 2, 5, 10, 11 and 13 , Helgason teaches a method for producing a multilayer-structured artificial skin (Fig. 2) comprised of a scaffold layer and a dermal layer (para. [0003]). The scaffold can comprise collagen and cellulose acetate (para. [109]). The dermal layer can comprise collagen (para. [0003]) and a stromal cell, such as a fibroblast. The scaffold can comprise a natural tissue adhesive, such as fibrin glue (para. [0003]). Regarding claims 4 and 12 , Helgason discloses ridges at dermal-epidermal junctions (para. [0196], Fig. 10) that are being compared to an in vivo skin biopsy. Regarding claims 6 and 14 , Helgason discloses a third layer (epidermal) comprising epithelial cells, such as a keratinocyte (para. [0004]). Regarding claims 8 and 15 , Helgason teaches that the epithelial cells of claims 6 and 14 can be (para. [0123]) squamous cells, cuboidal cells, columnar cells, basal cells, or a combination thereof . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Helgason in view of Panengad et al. (Panengad et al. Tissue Transglutaminase as a Biological Tissue Glue, ICBME 2008, Proceedings 23, pp. 1496–1498, 2009 www.springerlink.com) . Regarding claim 3 , Helgason teaches all of the elements of the current invention as stated above except for the use of transglutaminase 2 (TR2) as an adhesive, explicitly. However, Panengad discloses (Introduction) that TR2 is likely to be involved in crosslinks anchoring fibrils of the dermo-epidermal junction and plays a role in wound healing/repair. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the TR2 of Panengad with the artificial skin model of Helgason. Doing so would improve adhesion at the molecular level due to TR2’s function in the covalent transamidation cross linking of extracellular matrix proteins, as recognized by Panengad . 07-21-aia AIA Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Helgason . Regarding claim 7 , Helgason discloses a third layer comprising epithelial cells, as stated above. However, Helgason does not teach the third layer (epidermal) being located on the second layer (scaffold). It is well known that scaffolds are designed to mimic the natural extracellular matrix (ECM) of a tissue. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the epidermal layer of Helgason on the scaffold layer for structural support and to enhance ECM formation . 07-21-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Helgason in view of Amano et al. (U.S. 20020193875 A1; hereinafter Amano) Regarding claim 9 , Helgason teaches that additives to the medium can comprise TGF-β (para. [0126]) but does not explicitly disclose TGF-β2. Amano discloses the use of TGF-β2 (paras. [0030 and 0031]) as a matrix protein production promoting agent in the case of artificial skin formation. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the TGF-β2 of Amano with the artificial skin model of Helgason. Doing so would add a matrix protein production promoting agent to the model, thereby enhancing ECM remodeling/formation . 07-21-aia AIA Claim s 16 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Helgason in view of Michelet et al. (The anti-ageing potential of a new jasmonic acid derivative (LR2412): in vitro evaluation using reconstructed epidermis Episkin™. Exp Dermatol. 2012;21(5):398-400.; hereinafter Michelet) . Regarding claims 16 – 18 , Helgason teaches all of the elements of the current invention as stated above except for using the model in skin aging research. However, Michelet discloses a method for testing the anti-aging potential of a jasmonic acid derivative, which is involved in tissue regeneration, on an in vitro reconstructed skin model, Episkin™ (Abstract). Michelet further discloses how the effectiveness of the substance was determined: RTQPCR for hyaluronan synthase (2 and 3) expression and HES staining to determine if the epidermis thickness (density) increased (p. 399, Fig. 1a and Fig. 2a, respectively). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the engineered skin equivalent of Helgason with the method of Michelet for screening, testing and determining the effectiveness of a candidate substance for inhibiting skin aging. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached Monday-Friday 9:00A - 5:00P. 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, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WALTER JACKSON III/Examiner, Art Unit 1638 /Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638 Application/Control Number: 18/423,327 Page 2 Art Unit: 1638 Application/Control Number: 18/423,327 Page 3 Art Unit: 1638 Application/Control Number: 18/423,327 Page 4 Art Unit: 1638 Application/Control Number: 18/423,327 Page 5 Art Unit: 1638 Application/Control Number: 18/423,327 Page 6 Art Unit: 1638
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