DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission containing a claim amendment and remarks filed on 4/28/26 has been entered.
New claims 33-42 have been added. Claims 23-42 are now pending and under examination in this application. An action on the merits follows. The present application is being examined under the pre-AIA first to invent provisions.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New claims 33 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an antibody producing B cell isolated from the transgenic chicken of claim 23, wherein the cell produces the fusion protein, and a hybridoma made by fusing the antibody producing B cell isolated from the transgenic chicken of claim 23 and a myeloma, does not reasonably provide enablement for any isolated cell obtained from the transgenic chicken where the cell produces the fusion protein, or a hybridoma made by fusing any isolated cell from the transgenic chicken and any other cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Claim 33 recites an isolated cell of a transgenic chicken or claim 23, wherein the cell produces the fusion protein. Claim 34 recites a hybridoma made by fusing an isolated cell of claim 33 and another cell. The transgenic chicken set forth in claim 23 has a genome comprising a heavy chain locus which comprises the fusion protein operatively linked to a heavy chain constant region gene. The specification provides general disclosure for cells expressing the fusion protein and for using such cells to prepare hybridomas. The specific guidance provided by the specification discloses expression of the fusion protein from the heavy chain locus using a heavy chain promoter in antibody producing cells, such as cells present in the spleen, and in particular antibody producing B lymphocytes- see for example specification pages 12-13 and 19. The specification does not provide any guidance for cells other than antibody-producing cells which are capable of expressing the fusion protein, and further does not provide any guidance for antibody-producing cells other than B cells. It is further noted that the only disclosure provided in the specification for the production of hybridomas states, “…antibody-producing cells, e.g., spleen cells, may be isolated from the immunized transgenic animal and used either in cell fusion with transformed cell lines for the production of hybridomas….” (specification, page 19). The specification provides no guidance for the characteristics of the transformed cell line, and no guidance for methods of cell fusion.
At the time of filing, methods of making antibody producing hybridomas were well known. Burns et al. for example teaches that the process for producing a hybridoma was developed and the term “hybridoma” coined in 1975, where immunized antibody producing spleen cells were fused with myeloma cells in the presence of at least polyethylene glycol (Burns (2001) Methods in Molecular Biology: Immunochemical Protocols, Chapter 4-Making Hybridomas, pages 41-53-see pages 41-42). Burns states that the techniques for making hybridomas have not changed much from the early pioneering work in the field (Burns, page 42). Tomita et al., in a recent review of hybridoma technology teaches, like Burns, that the original hybridoma technology involved the fusion of antigen-sensitized B lymphocytes and myeloma cells in the presence of hemagglutinating virus of Japan (HVJ) and polyethylene glycol to produce hybridoma cells (Tomita et al. (2011) Hybridoma Technologies for Antibody Production, Immunotherapy, Vol. 3(3), 371-380, published online 3/11/11, see page 371). Tomita et al. teaches that while several new methods of fusing B lymphocytes and myeloma cells have been developed, such as pearl-chain formation and laser radiation fusion, the components of a hybridoma, i.e. the fusion partners, has not changed and continues to be a B lymphocyte and myeloma cell (Tomita et al., pages 372-373). Thus, the state of the prior art in regards to antibody producing cells and the process of making a hybridoma, as represented by Burns and Tomita et al., does not support the production of a hybridoma cell by fusing any cells other than an antibody producing B cell and a myeloma. It is further noted that neither the prior art at the time of filing, nor the nature of the heavy chain locus and its expression, supports expression of an antibody, or expression of a fusion protein expressed from a heavy chain locus, in any cell other than a B cell.
Therefore, in view of the state of the prior art at the time of filing for cells which naturally express antibodies or antibody fusion protein from the heavy chain locus, the state of the art at the time of filing for hybridoma production which requires the fusion of an antibody producing B cell and a myeloma cell, the lack of guidance in the specification for cells other than B cells which express the fusion protein from the heavy chain locus in the chicken, the lack of guidance in the specification for particular methods of making a hybridoma, and the breadth of the claims, it would have required undue experimentation to make and use the scope of cells encompassed by claims 33-34.
Allowable Subject Matter
Note that claims 23-32 were previously allowed as set forth in the Notice of Allowance mailed on 2/3/26.
Claims 23-32 as amended and new claims 35-42 are now considered free of the prior art of record and allowed.
Additional Comments
It is noted that a terminal disclaimer was submitted on 1/5/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 9,394,372, or U.S. Patent No. 11,602,136, or U.S. Patent No. 9,982,062. As such, non-statutory double patenting has not been applied to new claims 33-42.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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