Capon v. Eshhar
| Decision Date | 12 August 2005 |
| Docket Number | No. 03-1480.,No. 03-1481.,03-1480.,03-1481. |
| Parties | Daniel J. CAPON, Arthur Weiss, Brian A. Irving, Margo R. Roberts, and Krisztina Zsebo, Appellants, v. Zelig ESHHAR, Daniel Schindler, Tova Waks, and Gideon Gross, Cross-Appellants, v. Jon Dudas, Director of the Patent and Trademark Office, Intervenor. |
| Court | U.S. Court of Appeals — Federal Circuit |
Steven B. Kelber, Piper Rudnick, LLP, of Washington, DC, argued for appellants.
Roger L. Browdy, Browdy and Neimark, P.L.L.C., of Washington, DC, argued for cross-appellants.
Mary L. Kelly, Associate Solicitor, Office of the Solicitor, United States Patent and Trademark Office, of Arlington, Virginia, argued for intervenor. With her on the brief were John M. Whealan, Solicitor and Stephen Walsh, Associate Solicitor.
Before NEWMAN, MAYER,* and GAJARSA, Circuit Judges.
Both of the parties to a patent interference proceeding have appealed the decision of the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office, wherein the Board held that the specification of neither party met the written description requirement of the patent statute. Capon v. Eshhar, Interf. No. 103,887 . The Board dissolved the interference and cancelled all of the claims of both parties corresponding to the interference count. With this ruling, the Board terminated the proceeding and did not reach the question of priority of invention. We conclude that the Board erred in its application of the law of written description. The decision is vacated and the case is remanded to the Board for further proceedings.
Daniel J. Capon, Arthur Weiss, Brian A. Irving, Margo R. Roberts, and Krisztina Zsebo (collectively "Capon") and Zelig Eshhar, Daniel Schindler, Tova Waks, and Gideon Gross (collectively "Eshhar") were the parties to an interference proceeding between Capon's United States Patent No. 6,407,221 ("the '221 patent") entitled "Chimeric Chains for Receptor-Associated Signal Transduction Pathways" and Eshhar's patent application Serial No. 08/084,994 ("the '994 application") entitled "Chimeric Receptor Genes and Cells Transformed Therewith." Capon's Patent No. 5,359,046 ("the '046 patent"), parent of the '221 patent, was also included in the interference but was held expired for non-payment of a maintenance fee. The PTO included the '046 patent in its decision and in its argument of this appeal.1
A patent interference is an administrative proceeding pursuant to 35 U.S.C. §§ 102(g) and 135(a), conducted for the purpose of determining which of competing applicants is the first inventor of common subject matter. An interference is instituted after the separate patent applications have been examined and found to contain patentable subject matter. Capon's patents had been examined and had issued before this interference was instituted, and Eshhar's application had been examined and allowed but a patent had not yet issued.
During an interference proceeding the Board is authorized to determine not only priority of invention but also to redetermine patentability. 35 U.S.C. § 6(b). The question of patentability of the claims of both parties was raised sua sponte by an administrative patent judge during the preliminary proceedings. Thereafter the Board conducted an inter partes proceeding limited to this question, receiving evidence and argument. The Board then invalidated all of the claims that had been designated as corresponding to the count of the interference, viz., all of the claims of the Capon '221 patent, claims 5-8 of the Capon '046 patent, and claims 1-7, 9-20, and 23 of the Eshhar '994 application.
In accordance with the Administrative Procedure Act, the law as interpreted and applied by the agency receives plenary review on appeal, and the agency's factual findings are reviewed to determine whether they were arbitrary, capricious, or unsupported by substantial evidence in the administrative record. See 5 U.S.C. §706(2); Dickinson v. Zurko, 527 U.S. 150, 164-65, 119 S.Ct. 1816, 144 L.Ed.2d 143 (1999); In re Gartside, 203 F.3d 1305, 1315 (Fed.Cir.2000).
A chimeric gene is an artificial gene that combines segments of DNA in a way that does not occur in nature. The '221 patent and '994 application are directed to the production of chimeric genes designed to enhance the immune response by providing cells with specific cell-surface antibodies in a form that can penetrate diseased sites, such as solid tumors, that were not previously reachable. The parties explain that their invention is a way of endowing immune cells with antibody-type specificity, by combining known antigen-binding-domain producing DNA and known lymphocyte-receptor-protein producing DNA into a unitary gene that can express a unitary polypeptide chain. Eshhar summarized the problem to which the invention is directed:
Antigen-specific effector lymphocytes, such as tumor-specific T cells, are very rare, individual-specific, limited in their recognition spectrum and difficult to obtain against most malignancies. Antibodies, on the other hand, are readily obtainable, more easily derived, have wider spectrum and are not individual-specific. The major problem of applying specific antibodies for cancer immunotherapy lies in the inability of sufficient amounts of monoclonal antibodies (mAb) to reach large areas within solid tumors.
Technical Paper Explaining Eshhar's Invention, at 6.
The inventions of Capon and Eshhar are the chimeric DNA that encodes single-chain chimeric proteins for expression on the surface of cells of the immune system, plus expression vectors and cells transformed by the chimeric DNA. The experts for both parties explain that the invention combines selected DNA segments that are both endogenous and nonendogenous to a cell of the immune system, whereby the nonendogenous segment encodes the single-chain variable ("scFv") domain of an antibody, and the endogenous segment encodes cytoplasmic, transmembrane, and extracellular domains of a lymphocyte signaling protein. They explain that the scFv domain combines the heavy and light variable ("Fv") domains of a natural antibody, and thus has the same specificity as a natural antibody. Linking this single chain domain to a lymphocyte signaling protein creates a chimeric scFv-receptor ("scFvR") gene which, upon transfection into a cell of the immune system, combines the specificity of an antibody with the tissue penetration, cytokine production, and target-cell destruction capability of a lymphocyte.
The parties point to the therapeutic potential if tumors can be infiltrated with specifically designed immune cells of appropriate anti-tumor specificity.
The Board held unpatentable the following claims of Eshhar's '994 application; these were all of the '994 claims that had been designated as corresponding to the count of the interference. Eshhar's claim 1 was the designated count.
1. A chimeric gene comprising
which chimeric gene, upon transfection to said cells of the immune system, expresses said scFv domain and said domains of said endogenous protein in one single chain on the surface of the transfected cells such that the transfected cells are triggered to activate and/or proliferate and have MHC nonrestricted antibody-type specificity when said expressed scFV domain binds to its antigen.
2. A chimeric gene according to claim 1 wherein the second gene segment further comprises partially or entirely the extracellular domain of said endogenous protein.
3. A chimeric gene according to claim 1 wherein the first gene segment encodes the scFv domain of an antibody against tumor cells.
4. A chimeric gene according to claim 1 wherein the first gene segment encodes the scFv domain of an antibody against virus infected cells.
5. A chimeric gene according to claim 4 wherein the virus is HIV.
6. A chimeric gene according to claim 1 wherein the second gene segment encodes a lymphocyte receptor chain.
7. A chimeric gene according to claim 6 wherein the second gene segment encodes a chain of the T cell receptor.
9. A chimeric gene according to claim 7 wherein the second gene segment encodes the `,', ^, or [&sign] chain of the antigen-specific T cell receptor.
10. A chimeric gene according to claim 1 wherein the second gene segment encodes a polypeptide of the TCR/CD3 complex.
11. A chimeric gene according to claim 10 wherein the second gene segment encodes the zeta or eta isoform chain.
12. A chimeric gene according to claim 1 wherein the second gene segment encodes a subunit of the Fc receptor or IL-2 receptor.
13. A chimeric gene according to claim 12 wherein the second gene segment encodes a common subunit of IgE and IgG binding Fc receptors.
14. A chimeric gene according to claim 13 wherein said subunit is the gamma subunit.
15. A chimeric gene according to claim 13 wherein the second gene segment encodes the CD16' chain of the Fc^RIII or Fc^RII.
16. A chimeric gene according to claim 12 wherein the second gene segment encodes the `or' subunit of the IL-2 receptor.
17. An expression vector comprising a chimeric gene according to claim 1.
18. A cell of the immune system endowed with antibody specificity transformed with an expression vector according to claim 17.
19. A cell of the immune system endowed with antibody specificity comprising a chimeric gene according to claim 1.
20. A cell if the immune system according to claim 19 selected from the group consisting of a natural killer cell, a...
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