Opinion ID: 784861
Heading Depth: 2
Heading Rank: 2

Heading: The Interference

Text: 4 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. 5 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. 6 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: 7 The monoclonal antibody of claim 1 of 5,474,771 or the monoclonal antibody of claim 42 or claim 51 of 08/742,480. 8 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. 9 Claim 42 of Noelle's '480 application reads as follows: 10 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. 11 Claim 51 of Noelle's '480 application reads as follows: 12 A monoclonal antibody or fragment thereof which specifically binds CD40CR. 13 Claim 52 of Noelle's '480 application reads as follows: 14 The monoclonal antibody or fragment of Claim 51, wherein said CD40CR is expressed by activated human T cells. 15 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. 16 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. 17 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. 18 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 existed between the two parties' claims. Lederman then withdrew his pending motions and filed a new motion requesting that the Board find no interference-in-fact. 19 The Board concluded from the evidence submitted that there was no interference-in-fact. The Board reasoned that a person of ordinary skill in the art lacked a reasonable expectation of success of obtaining the other party's claimed invention given the state of the art at the time. The Board noted three different methods disclosed in Noelle's '480 specification by which a person of ordinary skill in the art could have isolated the human form of the CD40CR antibody given the mouse version of the CD40CR antibody. Dr. Edward A. Clark, Noelle's expert, declared that a person skilled in the art would have had a reasonable expectation of success in isolating human CD40CR antibody by utilizing the methods disclosed in Noelle's specification. 20 First, Clark testified that human CD40CR antibody could be isolated by immunizing a host with human CD40CR antigen expressing cells or cell lines and selecting the antibody to the CD40CR antigen by functional or competition binding with CD40-Ig. 5 Next, Clark suggested methods of making and isolating antibodies using affinity purified human CD40CR antigen. Last, Dr. Clark declared that one skilled in the art could use the mouse CD40CR antibody or CD40-Ig to clone CD40CR antigen DNA using a method known as expression cloning. 21 The Board found that one skilled in the art would not have had a reasonable expectation of success of isolating human CD40CR antibodies given the mouse form of CD40CR antigen. At the outset, the Board reasoned that any reference to Noelle's own specification as prior art was improper because the specifications underlying the respective claims cannot be considered prior art and an interference-in-fact analysis requires the comparison between the parties' claims, not their specifications. In re Vaeck, 947 F.2d 488, 493 (Fed.Cir.1991). Nevertheless, the Board refuted the three methods disclosed in Noelle's specification and endorsed by Clark. First, the Board found that the immunization technique found in the prior art would be ineffective because, at the relevant time, one skilled in the art would not have had a reasonable expectation of success of identifying the activated T-cells that produced the required CD40CR antigen or of isolating the antigen itself. Second, the Board found that it would have been extremely difficult for a person of ordinary skill in the art to isolate successfully CD40-Ig, which, as Noelle asserted, could then be used to obtain the claimed CD40CR antibodies. Third, the Board cited statements made during the prosecution of Armitage application 07/969,703 for the proposition that a skilled artisan could not have used expression cloning to isolate CD40CR antibody with a reasonable likelihood of success. 22 Thus, the Board determined that a person of ordinary skill in the art would not have been reasonably likely to isolate human CD40CR antibody given Noelle's claimed invention of mouse CD40CR antibody. As a result, the Board found no interference-in-fact between Noelle's remaining murine CD40CR antibody claim and Lederman's claim to the human form of CD40CR antibody. Noelle timely appealed to this court and we have jurisdiction under 28 U.S.C. § 1295(a)(4)(A) (2000).