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 .
Claim Status
Applicant’s election without traverse of claims 6, 14, 15 and 18 – 25 in the reply filed on June 1, 2026, is acknowledged.
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.
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.
Claims 6, 14 – 15 and 18 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over Shimpei et al. (W.O. Patent Application Publication No. 2016143803 A1; cited on IDS, hereinafter Shimpei) in view of Shoji et al. (W.O. Patent Application Publication No. 2015178427 A1; cited on IDS, hereinafter Shoji). The machine translations are referenced.
Regarding claims 6, 14 and 23, Shimpei discloses a method for producing type II alveolar epithelial cells from pluripotent stem cells, the method comprising a step for inducing differentiation of alveolar epithelial progenitor cells three-dimensionally in a culture medium (Abstract). Shimpei further discloses differentiating the pluripotent stem cells into progenitor ventral anterior foregut cells (Abstract). Shimpei does not discloses a structure for the culturing of cells.
However, Shoji describes (Abstract) a three-dimensional cell hollow microfiber structure comprising: a fiber substrate with a core part and a shell part, which were formed from hydrogels (such as alginate gel); and cells (p. 2, Background – Description-Of-Embodiments). Shoji suggests that the structure can be manufactured using various types of cells including epithelial cells
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 use the alveolar epithelial cells of Shimpei in the 3D cell structure of Shoji. Doing so would allow for the development of artificial construction technology for in vivo tissues with luminal structures such as lungs.
Regarding claim 15, Shoji discloses a cell density of 1.0 x 106 to 1.0 x 108 cells/mL for seeding the structure (p. 16, Middle of page).
Regarding claims 18 and 19, Shimpei discloses in their invention, the alveolar epithelial progenitor cells express CPM and/or NKX2-1 (p. 3, Middle of page). The cells also express FOXA2 (p. 7, Bottom of page), and SOX2 (p. 9, Bottom of page). Shimpei does not disclose SRY-box 9 expression. However, it would be obvious to test SRY-box levels based on Shimpei’s disclosure of Sox2, 1, 3, 15 and 17 (p. 18, Middle of the page).
Regarding claim 20, Shimpei discloses that the cells grow in spheroids (p. 27, FIG. 5 and FIG. 6 descriptions).
Regarding claim 21, Shoji discloses (p. 14, Top of the page) that the cell-adhesive hydrogel is selected from a group that comprises the limitations of instant claim 21.
Regarding claims 22 and 25, Shoji discloses (p. 2, Background) that the core unit is where the cells are mixed with collagen and fibrin, and that the outer shell will be alginate gel.
Regarding claim 24, Shimpei discloses the culturing method of claim 14 that includes the limitations of instant claim 24 (P. 33, Middle of page).
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 M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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