Noelle v. Lederman

• Decision Date: 20 January 2004
• Docket Number: No. 02-1187.,02-1187.
• Citation: 355 F.3d 1343
• Parties: Randolph J. NOELLE, Appellant, v. Seth LEDERMAN, Leonard Chess, and Michael J. Yellin, Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

Page 1343

355 F.3d 1343

Randolph J. NOELLE, Appellant, v. Seth LEDERMAN, Leonard Chess, and Michael J. Yellin, Appellees.

No. 02-1187.

United States Court of Appeals, Federal Circuit.

January 20, 2004.

E. Anthony Figg, Rothwell, Figg, Ernst & Manbeck, of Washington, DC, argued for appellant. With him on the brief was Glenn E. Karta.

James F. Haley, Jr., Fish & Neave, of New York, NY, argued for appellees. With him on the brief were Margaret A. Pierri and Jane T. Gunnison. Of counsel on the brief was John P. White, Cooper & Dunham LLP, of New York, NY. Of counsel was Stanley Den-Kua Liang, Fish & Neave.

Before CLEVENGER, BRYSON, and GAJARSA, Circuit Judges.

GAJARSA, Circuit Judge.

This is an appeal from an interference proceeding involving the claims of United States Patent Application Serial No. 08/742,480 (the "'480 application") and United States Patent No. 5,474,771 (the "'771 patent"). Randolph J. Noelle ("Noelle") is the inventor named on the '480 application. Seth Lederman, Leonard Chess, and Michael J. Yellin (collectively "Lederman") are the inventors named on the '771 patent. Noelle appeals the decision of the United States Patent and Trademark Office, Board of Patent Appeals and Interferences ("Board"), finding no interference-in-fact between the '480 application and the '771 patent and rejecting claims 51, 52, 53, 56, 59, and 60 of the '480 application pursuant to 35 U.S.C. § 102(b) (2000). Noelle v. Lederman, Interference No. 104,415 (Bd. Pat.App. & Int. Oct. 19, 2001). Because the decision of the Board is supported by substantial evidence and is not contrary to law, we affirm.

BACKGROUND

A. Antibodies

This case relates to antibodies and their role in the immune response system. A vertebrate's immune system serves to identify and destroy foreign invading organisms and neutralize the toxic molecules they produce. Antibodies, which are proteins also referred to as immunoglobulins ("Ig"), serve to designate foreign particles, broadly referred to as antigens, for destruction by other components of the immune system such as lymphocytes.¹ Lymphocytes, otherwise known as white blood cells, produce antibodies and destroy antigens. T-cells and B-cells are the two types of lymphocytes needed for antibody production. One specific type of T-cell is the helper T-cell. Helper T-cells recognize antigens and then induce B-cells to produce antibodies through a series of events. First the helper T-cell is activated after it recognizes an antigen. Once activated, the helper T-cell activates the B-cell by a combination of binding with the B-cell and secreting signaling molecules. Once the B-cell is activated, it differentiates,² proliferates, and produces antibodies specific to a particular antigen. The antibodies then circulate in the bloodstream and permeate other bodily fluids, where they bind to the antigen, thereby flagging it for destruction.

The present interference involves competing claims to an antibody ("CD40CR antibody") that represses the cell-to-cell signaling interaction between helper T-cells and B-cells. CD40CR antigen³ is found on activated, but not resting, helper T-cells. CD40CR antigen acts as a "key" to unlock a protein ("CD40") located on the surface of resting B-cells. Once CD40CR antigen and CD40 bind, the B-cell begins down the pathway to differentiation, proliferation, and antibody production. The CD40CR antibody binds to the CD40CR antigen located on the T-cell surface, thereby inhibiting its ability to bind to the CD40 receptor located on the resting B-cell. B-cells cannot then become activated, thereby preventing the B-cell from producing antibodies. CD40CR antibodies are useful for treating a hyperactive immune system that causes allergic reactions and autoimmune diseases.

B. The Interference

Noelle's '480 application was filed November 1, 1996. The '480 application is a continuation of application Serial No. 08/338,975 ("the '975 application"), filed November 14, 1994, which is in turn a continuation of application Serial No. 07/835,799 ("the '799 application"), filed on February 14, 1992. The claims of Noelle's '480 application are directed to the genus, murine ("mouse"), chimeric ("hybrid"), humanized, and human forms of the CD40CR monoclonal antibody. Noelle also claims the hybridomal⁴ cell lines that produce the CD40CR antibody.

Lederman's '771 issued patent has an effective filing date of November 15, 1991. Lederman's '771 patent describes and claims the human form of CD40CR monoclonal antibody (the "5c8 antibody"). The 5c8 antibody binds to "the 5c8 antigen located on the surface of activated T cells and thereby inhibits T cell activation of B cells." Also, Lederman claims a hybridomal cell line created to produce monoclonal antibody 5c8.

On September 3, 1999, an interference was declared by the United States Patent and Trademark Office ("USPTO") between the issued claims of Lederman's '771 patent and Noelle's '480 application. Noelle was designated the junior party and Lederman was designated the senior party based on their effective filing dates. The USPTO established only one count in the interference. The count reads as follows:

The monoclonal antibody of claim 1 of 5,474,771 or the monoclonal antibody of claim 42 or claim 51 of 08/742,480.

Claim 1 of Lederman's '771 patent reads as follows:

A monoclonal antibody, which specifically binds and forms a complex with the 5c8 antigen located on the surface of activated T cells and thereby inhibits T cell activation of B cells, the 5c8 antigen being an antigen to which monoclonal antibody 5c8 (ATCC Accession No. HB 10916) specifically binds.

Claim 42 of Noelle's '480 application reads as follows:

A monoclonal antibody or fragment thereof which specifically binds to an antigen expressed on activated T cells, wherein said antigen is specifically bound by the monoclonal antibody secreted by hybridoma MR1 which hybridoma has been deposited and accorded ATCC Accession No. HB 11048.

Claim 51 of Noelle's '480 application reads as follows:

A monoclonal antibody or fragment thereof which specifically binds CD40CR.

Claim 52 of Noelle's '480 application reads as follows:

The monoclonal antibody or fragment of Claim 51, wherein said CD40CR is expressed by activated human T cells.

For sake of the simplicity, Claim 1 of Lederman's '771 patent and Claim 52 of Noelle's '480 application will be referred to as claims to the "human" form of CD40CR antibody. Claims 42 and 51 of Noelle's '480 application will be referred to as claims to the "mouse" and "genus" forms of CD40CR antibody, respectively.

On June 28, 2001 the Board held a hearing to dispose of the parties' preliminary motions. Lederman moved to have Noelle's claims rejected and sought to redefine the count. Likewise, Noelle also sought to have the count redefined. The Board denied Lederman's motions for judgment against Noelle's mouse claims for lack of written description, lack of enablement, and indefiniteness. See 35 U.S.C. § 112 (2000). The Board found that Lederman had failed to demonstrate that the mouse claims in Noelle's '480 application failed to comply with 35 U.S.C. § 112, paragraphs (1) and (2), as of November 1, 1996, the date Noelle filed his '480 application. The Board, however, determined that the human and genus claims in Noelle's '480 application failed to comply with the written description requirement pursuant to 35 U.S.C. § 112, paragraph (1), as of February 14, 1992, the date Noelle filed the previous '799 application. The Board made a detailed analysis of this court's precedent pertaining to the doctrine of written description, focusing on the holding from Regents of the University of California v. Eli Lilly & Co. that an "adequate written description of a DNA sequence claim requires a precise definition, such as structure, formula, chemical name, or physical properties." 119 F.3d 1559, 1566 (Fed.Cir.1997). The Board analogized the DNA claims from Regents to the antibodies in Noelle's application. Accordingly, the Board held that Noelle's claims regarding the genus and human claims from the '480 application lacked written description support in the specification of Noelle's earlier '799 application because Noelle failed to describe any structural features of the human or genus antibodies or antigens. In other words, the Board found that the claims covering the genus and human antibodies constituted new matter because they lacked adequate written description in Noelle's earlier '799 application. The Board did not reject the claims, but rather denied them the benefit of the earlier filing date of Noelle '799.

Next, the Board addressed the implication of finding a lack of written description for the genus and human claims in Noelle's '480 application. The Board determined that the claims to the human and genus forms of CD40CR antibody in Noelle's '480 application were anticipated by either Lederman '771, which claims priority to U.S. Application 07/792,728, filed November 15, 1991, or Armitage 5,961,974 (the "'974 patent"), which claims priority to U.S. applications 07/783,707 and 07/805,723 filed October 25, 1991, and December 5, 1991, respectively. Noelle had not attempted to distinguish his human and genus claims from the prior art and had conceded that Lederman '771 and Armitage '974 would anticipate those claims if the '480 application were not afforded the earlier filing date of Noelle's '799 application. Thus, the Board found the genus and human claims of Noelle's '480 application to be anticipated under 35 U.S.C. § 102(b) by the two forms of prior art and, as a result, rejected the claims to the human and genus forms of CD40CR antibodies and their respective cell lines pursuant to 37 C.F.R. § 1.641.

On October 19, 2001, the Board ruled on the motions remaining from the previous hearing. The Board had determined in its previous hearing that the deferred motions were essentially requests to decide whether an interference-in-fact...