Randolph J. Noelle v. Seth Lederman, Leonard Chess, and Michael J. Yellin

355 F.3d 1343, 69 U.S.P.Q. 2d (BNA) 1508, 2004 U.S. App. LEXIS 774, 2004 WL 77931
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 20, 2004
Docket02-1187
StatusPublished
Cited by33 cases

This text of 355 F.3d 1343 (Randolph J. Noelle v. Seth Lederman, Leonard Chess, and Michael J. Yellin) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Randolph J. Noelle v. Seth Lederman, Leonard Chess, and Michael J. Yellin, 355 F.3d 1343, 69 U.S.P.Q. 2d (BNA) 1508, 2004 U.S. App. LEXIS 774, 2004 WL 77931 (Fed. Cir. 2004).

Opinion

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-eell activates the B-cell *1345 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 antigen 3 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 hybridomal 4 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 hybrido-mal 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 Led-erman 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:

*1346 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 hybri-doma 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 en-ablement, 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

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355 F.3d 1343, 69 U.S.P.Q. 2d (BNA) 1508, 2004 U.S. App. LEXIS 774, 2004 WL 77931, Counsel Stack Legal Research, https://law.counselstack.com/opinion/randolph-j-noelle-v-seth-lederman-leonard-chess-and-michael-j-yellin-cafc-2004.