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
Claims 1 – 19 are pending.
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 1 – 6, 8 – 10 and 12 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (W.O. Patent Application No. 2019/103129 A1). This document is not in English, U.S. 20200345784 is used as an English equivalent and the citations below are to that document.
Regarding claims 1 – 6 and 16 – 19, Nakano teaches a cell aggregate containing a pituitary (Abstract) hormone-producing cell that is positive for EpCAM and E-cadherin (para. [0021], Fig. 10E and M). Nakano discloses that neural cells (para. [0001]) are a part of the aggregate and that some of the cells are ACTH-positive cells (Fig. 2C) and have the capacity to secrete growth hormone (Fig. 2H). Nakano further discloses that the cells form plane attachments (para. [0048]) with cell adhesion factors (E-cadherin and EpCAM) and the structure of a cell mass containing sponge-like pituitary tissue (Fig. 1 – 2). Furthermore, Nakano discloses that the cell mass produced can be used as a therapeutic drug for a disorder of the pituitary gland. Nakano teaches all of the elements of the current invention except the cellular proportions, densities, size, and secretory capacity of the cell aggregate. However, these are optimizable qualities that can be manipulated to generate the instant application’s cell aggregate based on Nakano’s disclosed invention. The motivation would be to modify/optimize the protocol of Nakano for generating a more physiologically accurate/functional pituitary cell aggregate capable of secreting pituitary hormones.
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 modify/optimize Nakano’s protocol with the cellular proportions, densities, size, and secretory capacity of the instant application’s claims 1 – 5 and 16 – 19. Doing so would optimize the secretory capacity/utility of the aggregate for further research into pituitary function and dysfunction.
Regarding claim 7, Nakano teaches all of the elements of the current invention as stated above except a method that explicitly teaches separating an EpCAM-expressing cell from a dispersed cell population and allowing it to mature into a pituitary hormone-producing cell. However, Nakano does disclose the use of EpCAM as mentioned above. The motivation for using an EpCAM expressing cell to generate a pituitary hormone-producing cell for recombining the cell types together would be for stronger cell adhesion in the aggregate.
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 utilize an EpCAM expressing cell to form a cell aggregate. Doing so would enhance the cellular adhesion needed for the aggregate to form.
Regarding claims 8 – 10 and 12, 13 and 15, Nakano discloses a two-step method for producing a cell that encompasses the limitations of claims 8 – 10 (Starting at Means of Solving the Problems [0008]; Production Methods [1] – [24]). Figures 1 – 1, 2, 3, 4, 11, 15 and 16 are different embodiments of a pituitary cell aggregate generating protocol which disclose schematics that encompass claims 12, 13 and 15.
Regarding claim 14, Nakano discloses that the pituitary hormone producing cell is at least one kind (Method [67]) selected from the group consisting of GH-producing cells, PRL-producing cells and ACTH-producing cells. This disclosure teaches that the cell aggregate can contain only an ACTH-producing pituitary hormone cell.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nakano in view of Semba et al. (JNK Signaling in Stem Cell Self-Renewal and Differentiation. International Journal of Molecular Sciences. 2020; 21(7):2613) hereinafter Semba.
Regarding claim 11, Nakano teaches all of the elements of the current invention as stated above except the use of a JNK signal transduction pathway inhibiting substance in a pituitary cell aggregate generating protocol. However, Semba discloses that JNK inhibitors (Sect. 3.1) allow for stem cells to differentiate into specialized cells and decreased OCT4 and NANOG expression. The JNK pathway is essential for regulating stem cell self-renewal and differentiation. The motivation would be to incorporate a JNK inhibitor in order to regulate cell differentiation and make a more efficient protocol to generate pituitary cell aggregates.
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 have combine the JNK inhibitor of Semba with the protocol of Nakano in order to generate a more reproducible and efficient protocol for differentiating stem cells into a pituitary cell aggregate. Doing so would allow the cells to differentiate more efficiently, according to Semba.
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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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.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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