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 .
Applicant's election without traverse of Group III, claims 6-8, in the reply filed on 8 July 2026 is acknowledged. Claims 1-5 and 9-11 have been withdrawn. Claims 6-8 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/JP2021/188216, filed 16 November 2022, which claims priority to Japanese patent document No. JP2021-188216, filed 18 November 2021.
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 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onizuka et al. (IDS; Application of Periodontal Ligament-Derived Multipotent Mesenchymal Stromal Cell Sheets for Periodontal Regeneration, International Journal of Molecular Sciences, (June 7, 2019), 20:2796, pp. 1-13).
With regard to claim 6, Onizuka et al. teach a method for producing a cell sheet, the method including obtaining periodontal ligament-derived mesenchymal stem cells (MSCs) (Title, Abs.; p. 3-4, 2.1.1 Periodontal Ligament (PDL)-Derived Cells). The obtained periodontal ligament-derived MSCs are then cultured on temperature responsive culture dishes in an osteoinductive medium, which is a calcification induction medium, to proliferate the cell population; the cultured cells form a cell sheet (p. 3-4, section: 2.1.1 Cell Sheet Engineering Technology for PDL-MSCs). The temperature responsive culture dishes are made of the polymer N-isopropylacrylamide (PIPAAm) (p. 3, 2.1.2. Cell Sheet Engineering Technology for PDL-MSCs, para. 1). Applicant broadly defines “plastic” as a synthetic resin material (see Specification, Para. 28). Thus, the PIPAAm culture dishes are a plastic substrate. Harvesting is done by reducing the temperature to lower than 32°C, which fully hydrates the PIPAAm and causes the cell sheet to be washed off the culture dishes. Thus, Onizuka et al. provides for recovering/washing the sheet-shaped cell population formed on the plastic substrate.
It is noted that Applicant utilizes periodontal ligament-derived MSCs, and that such cells have alkaline phosphatase activity (see Specification, Para. 15, Fig. 1). As periodontal ligament-derived MSCs cannot be separated from their properties, the periodontal ligament-derived MSCs obtained by Onizuka et al. necessarily have alkaline phosphatase activity.
With regard to claims 7 and 8, Onizuka et al. teach the method as claimed, utilizing the components as claimed, including periodontal ligament-derived MSCs, which are specifically employed by Applicant. As the periodontal ligament-derived MSCs cannot be separated from their properties, the periodontal ligament-derived MSCs obtained by Onizuka et al. necessarily have alkaline phosphatase activity of 1 U or more. Additionally, the result that the cell population has alkaline phosphatase activity of 5 U or more after culture in the calcification induction medium, would naturally flow from performance of the method as taught by Onizuka et al.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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