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

Heading: Interference-In-Fact

Text: 35 Interference proceedings are subjected to the requirements of 37 C.F.R. §§ 1.601-1.690 (2003), promulgated pursuant to 35 U.S.C. § 135(a). Eli Lilly v. Bd. of Regents of the Univ. of Wash., 334 F.3d 1264, 1267 (Fed.Cir.2003). A patent interference is designed to determine whether two patent applications (or a patent application and an issued patent) are drawn to the same `patentable invention' and, if so, which of the competing parties was first to invent the duplicative subject matter. Id. (citing Conservolite, Inc. v. Widmayer, 21 F.3d 1098, 1100-01 (Fed.Cir.1994)); see also 37 C.F.R § 1.601(j). 6 In order to determine whether the two parties claim the same patentable invention, the USPTO has promulgated a two-way test, which has been approved by this court. Eli Lilly, 334 F.3d at 1270. The two-way test reads as follows: 36 Invention A is the same patentable invention as an invention B when invention A is the same as (35 U.S.C. 102) or is obvious (35 U.S.C. 103) in view of invention B assuming invention B is prior art with respect to invention A. Invention A is a separate patentable invention with respect to invention B when invention A is new (35 U.S.C. 102) and non-obvious (35 U.S.C. 103) in view of invention B assuming invention B is prior art with respect to invention A. 37 37 C.F.R. § 1.601(n). In order for an interference-in-fact to exist, invention A must anticipate or make obvious invention B, and invention B must anticipate or make obvious invention A, thereby meeting both prongs of the two-way test. Eli Lilly, 334 F.3d at 1268; accord Winter v. Fujita, 53 U.S.P.Q.2d 1234, 1243 (Bd. Pat. App. & Int. Nov. 16, 1999). The Board in the present case worded the two-way test in a different way as follows: 38 Thus, for Lederman to succeed in its motion for no interference-in-fact, Lederman need only demonstrate that: (i) Lederman's claims are not anticipated or rendered obvious by Noelle's remaining mouse claims; or (ii) Noelle's remaining mouse claims are not anticipated or rendered obvious by Lederman's claims. 39 (Emphasis in original). 40 Noelle's argument that the Board improperly required a two-way patentability test, or, as the Board phrased it, a one-way distinctiveness test, is without merit in light of this court's recent ruling in Eli Lilly upholding the Director's two-way test as consistent with the language of the regulation. 334 F.3d at 1268. Therefore, the Board applied the proper two-way test. First, it determined that one skilled in the art lacked a reasonable expectation of success of obtaining Lederman's claimed `human' subject matter when provided with Noelle's `mouse' subject matter and using the screening techniques cited by Noelle. Although the Board did not have to conduct the second prong of the test to find no interference-in-fact, it did so anyway by finding that one skilled in the art would have lacked a reasonable expectation of success of obtaining Noelle's `mouse' subject matter when provided with Lederman's claimed `human' subject matter and using the same screening methods. Therefore, the Board utilized the correct test to find no interference-in-fact. 41 Noelle's argument that the Board erred in its application of the obviousness question in the interference-in-fact analysis by ignoring the specification in Noelle's '480 application is also without merit. Both Lederman and Noelle concede that the anticipation portion of the interference-in-fact analysis is not an issue in light of the agreed variance between claims to mouse versus human forms of CD40CR antibodies. Thus, only the obviousness analysis pursuant to 35 U.S.C. § 103 is left to be determined. Obviousness is determined as follows: 42 a proper analysis under § 103 requires, inter alia, consideration of two factors: (1) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and (2) whether the prior art would also have revealed that in so making or carrying out, those of ordinary skill would have a reasonable expectation of success. 43 In re Vaeck, 947 F.2d at 493. Both the suggestion and the reasonable expectation of success must be founded in the prior art, not in the applicant's disclosure. Id.; see also In re Dow Chem. Co., 837 F.2d 469, 473 (Fed.Cir.1988). 44 The parties agree that a skilled artisan would have been motivated to obtain the human CD40CR antibody if the mouse CD40CR antibody were available. The two parties disagree, however, as to whether the prior art would provide a reasonable likelihood of success in so doing. Therefore, the issue before us is whether substantial evidence supports the Board's determination that one of ordinary skill in the art would not have had a reasonable expectation of success of isolating the other party's invention given the disclosures found in the claims. A reasonable likelihood of success does not necessarily mean an absolute predictability, but rather a reasonable expectation of success. Yamanouchi Pharm. v. Danbury Pharmacal, Inc., 231 F.3d 1339, 1343 (Fed.Cir. 2000). 45 Noelle argues that the methods disclosed in his '799 patent application would have provided a reasonable likelihood of success for a person of ordinary skill in the art to isolate human CD40CR antibodies using mouse CD40CR antibodies. Specifically, Noelle argues it would have been obvious to a skilled artisan to use the CD40-Ig fusion protein disclosed in the '799 application as a screen to locate, within a hybridomal library, monoclonal antibodies that specifically bind to human CD40CR antigen. Noelle further argues the Board improperly ignored this method of antibody isolation merely because it was disclosed in Noelle's written description as opposed to Noelle's claims. 46 The Board correctly found no interference-in-fact between Noelle's claims and Lederman's claims. First, the Board was correct in not considering Noelle's methods of isolation of human CD40CR antigen using CD40-Ig found in his '799 specification because the methods were neither part of the parties' inventions nor prior art. USPTO rules establish that an interference-in-fact exists when both parties claim the same patentable invention. 37 C.F.R. 1.601(n). A patentee's invention is only found in a patentee's claims, unless the patentee uses sufficient means-plus-function language to invoke 35 U.S.C. § 112, paragraph (6). Thus, if the Board is to compare two inventions, the Board must only compare the parties' claims. Noelle does not claim a method of isolating CD40CR antigens, CD40-Ig, or the receptor CD40 itself. Obviously, if certain terms in Noelle's or Lederman's claims were ambiguous, we could resort to the specification or other sources to define those terms; however, it is unnecessary here as none of the terms in the claims are ambiguous. Therefore, Noelle cannot rely on a method of isolating human CD40CR antigen using CD40-Ig in order to prove obviousness between his invention and Lederman's invention because the method is not claimed. 47 Second, the Board's determination was supported by substantial evidence because a person of ordinary skill in the art, given the state of prior art at the time of the '799 filing, would not have had a reasonable likelihood of success in isolating human CD40CR antibodies from the mouse CD40CR antigen and its antibody. Noelle argues that one skilled in the art would have had a reasonable likelihood of success in manufacturing a set of hybridomas that secrete monoclonal antibodies to activated human helper T-cell surface antigens. Noelle, as outlined previously, cited three different screening methods disclosed in his specification that would isolate the desired hybridomas and their antibodies. The first two of Noelle's proposed screening methods require the use of CD40-Ig. As the expert testimony of Dr. Aruffo, the named inventor in the patent claiming CD40-Ig, indicated to the Board, it would have been unpredictable and unreasonable to expect a skilled artisan to produce CD40-Ig given the state of the art at the time. 48 Finally, Noelle's expert witness, Dr. Clark, addressed the third and final proposed screening method. Dr. Clark declared that, given the mouse form of CD40CR antibody or CD40-Ig and the utilization of expression cloning methods available at the time, a person of ordinary skill in the art would have had a reasonable expectation of success in isolating the human form of CD40CR antigen. Armitage, however, during the prosecution of his '703 application, stated that the use of expression cloning could not have reasonably led to successful isolation of human CD40CR antigen. 49 After examining the record as a whole, we conclude there was substantial evidence to support the Board's decision. The Board's decision was reasonable in that, given the state of the art in the early 1990s as described by the expert witnesses, a person of ordinary skill in the art would not have had a reasonable likelihood of success in isolating human CD40CR antigen given mouse CD40CR antigen.