Abbott argues in the alternative that the patents in question are rendered obvious by prior art under 35 U.S.C. § 103. Obviousness refers to the fact that "an invention must not have been obvious to one with ordinary skill in the art to which the subject matter of the invention pertains at the time of the invention and in light of the teachings of the prior art. [Obviousness] is distinct from novelty in the sense that an invention may be obvious even though it is not identically disclosed anywhere in the prior art." 2 DONALD S. CHISUM, CHISUM ON PATENTS § 5.01., at 5-10 to 5-11 (Rel. No. 51 Aug. 1994)
In its summary judgment motion, Abbott discusses obviousness only in reference to four of the Halbert claims, each of which contains a single element not disclosed in the Mukojima reference, arguing that these claims are rendered obvious by the Mukojima reference in combination with other prior art. Abbott argues that: (1) claims 4 and 5 of the '878 patent and claim 13 of the '285 patent, which recite the use of p-nitrophenyl phosphate as a substrate that reacts with an enzyme label to produce a detectable reaction product, are rendered obvious by a combination of the Mukojima reference and a 1973 publication by Luc Belanger, Abb. Ex. 10; and (2) claim 12 of the '878 patent, which recites the use of a horse globulin solution to eliminate non-specific false positives, is rendered obvious by a combination of the Mukojima reference and a 1971 Australian patent application filed by Pfizer Corporation. Abb. Ex. 18. Abbott apparently discusses only four claims in its obviousness discussion because it relies mainly on its anticipation claim in seeking summary judgment. Since the court finds that there are genuine issues of material fact to be resolved regarding the anticipation claim, the court could not grant summary judgment even if it were to find the four claims cited by Abbott to be obvious. As such, the court discusses obviousness mainly for the purpose of illuminating issues for trial.
Although the ultimate question of whether a patent claim is rendered obvious by prior art is a legal question, the determination is based on underlying factual questions. Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1572 (Fed. Cir. 1988), cert. denied, 488 U.S. 892, 109 S. Ct. 228, 102 L. Ed. 2d 218 (1988) (citations omitted). In Graham v. John Deere Co., 383 U.S. 1, 17, 86 S. Ct. 684, 694, 15 L. Ed. 2d 545 (1966), the Supreme Court stated that relevant factual questions had to be resolved before a legal determination could be made as to the question of obviousness, including: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; and (3) the level of ordinary skill in the pertinent art. Additional factors to consider include "objective considerations such as commercial success, long felt need, failure of others, and copying." Heidelberger Druckmaschinen v. Hantscho Commercial Prods., 21 F.3d 1068, 1071 (Fed. Cir. 1994) (citing Graham, 383 U.S. at 17, 86 S. Ct. at 693).
The court turns first to the issue of the scope and content of the prior art. "The 'scope' of the prior art determines what references fall within the relevant prior art." Joy Technologies, Inc. v. Quigg, 732 F. Supp. 227, 232-33 (D.D.C. 1990). Diamedix appears to argue that the Belanger and Pfizer references are not "analogous" to the Halbert patents since they refer to immunoassays that are not "sandwich"-type immunoassays. Diamedix Mem. in Opp. at 23. "Whether a reference in the prior art is "analogous" is a fact question." In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (citations omitted). Two criteria have evolved for deciding this question: "(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved." Id. (citations omitted). Diamedix's contention that the Belanger and the Pfizer references are not, at a minimum, reasonably pertinent to sandwich EIAS, is disingenuous. Even though Halbert and Mukojima dealt with "sandwich"-type immunoassays, the basic field these inventors worked in was that of immunoassays.
In fact, the Belanger reference dealt specifically with EIAS, the subject of both patents in question. Abb. Ex. 10. The Australian reference "relates to diagnostic reagents for the presence of hepatitis-associated antigen, also known as Hepatitis B antigen or Australia antigen, or for the presence of the antibody thereto, in blood samples." Abb. Ex. 18 at 2. Similarly, the '878 patent deals with an immunoassay test "provided for the detection of an antigen associated with hepatitis in body fluids." Diamedix Ex. G at 1. Certainly, the Australian reference is reasonably pertinent to the problems that Halbert attempted to solve. No reasonable jury could find other than that both references are "analogous" to the patents in question and, therefore, fall within the relevant prior art.
Turning to the "content" prong, "the 'content' of the prior art is what those references teach a person of ordinary skill in the art." Joy Technologies, 732 F. Supp. at 233. However, as already noted, the level of ordinary skill in the field of art in the early-to-mid-1970's is a factual question to be resolved at trial. Genuine issues of material fact, therefore, exist as to both the level of ordinary skill and the content of the prior art.
The court next turns to the issue of the differences between the prior art and the claims at issue. As a preliminary matter, it is up to the court to interpret the claims in light of the specifications and prosecution history. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1567-68 (Fed. Cir.), cert. denied, 481 U.S. 1052, 107 S. Ct. 2187, 95 L. Ed. 2d 843 (1987). As explained above, since summary judgment must be denied, the court declines to construe the claims at this juncture. At trial, the court will have more information upon which to make these legal determinations.
Finally, the court notes that in combining the Mukojima reference with the prior art, Abbott "cannot pick and choose among the individual elements of assorted prior art references to recreate the claimed invention," unless they can show "some teaching or suggestion in the references to support their use in the particular claimed combination." Smithkline Diagnostics v. Helena Labs. Corp., 859 F.2d 878, 886-87 (Fed. Cir. 1988). Abbott has not provided the court with enough facts to resolve, at this stage, whether the various combinations are supported in the references.
In conclusion, while the prior art cited by Abbott is relevant to the issue of obviousness, Abbott has not met its burden. The court must deny summary judgment on the issue of obviousness.
MOTION TO STRIKE
Finally, Abbott filed a motion to strike and/or dismiss certain of Diamedix's affirmative defenses and each of its counterclaims. However, after Abbott filed this motion, Diamedix filed an amended answer to its second amended complaint. Therefore, the court denies Abbott's motion without prejudice. Abbott may refile a similar motion no later than June 9, 1997.
Abbott's motion for summary judgment is denied. Abbott's motion to strike and/or dismiss certain of Diamedix's affirmative defenses and each of its counterclaims is denied without prejudice. Abbott may refile the latter motion no later than June 9, 1997.
IT IS SO ORDERED.
Harry D. Leinenweber, Judge
United States District Court