Prior court decision of no invalidity based on prior art reference doesn’t bar reexaminationSeptember 17, 2008

The Federal Circuit recently construed the scope of the revised reexamination statute, 35 U.S.C. § 303, specifically what is required for a "substantial new question of patentability." In this case, the relevant reference was cited during the initial examination of the application that led to the patent under reexamination, but as a supporting reference. The reference was also the subject of invalidity claims in an infringement litigation. In that case, the district court and Federal Circuit concluded the accused infringer had not met its burden to show invalidity by clear and convincing evidence. The losing party in the litigation then sought reexamination of the patent. The USPTO granted reexamination, and subsequently held the relevant claims unpatentable based on the same prior art asserted in the infringement case and used as a supporting reference during the original prosecution. The patentee appealed, arguing the reference could not pose a new question of patentability, given its previous consideration by both the USPTO and the Federal Circuit.The Federal Circuit affirmed. Noting the differing burdens of proof in litigation and reexamination, the court found the two outcomes were not necessarily contradictory. Further, given the amendment to § 303 in 2002, the court held that a substantial new question of patentability could be found even if the prior art was considered by the USPTO during the original prosecution. Under the revised statute, "a reference may present a substantial new question even if the examiner considered or cited a reference for one purpose in earlier proceedings." The relevant question is "whether the particular question of patentability presented by the reference in reexamination was previously evaluated by the PTO. . . . Section 303(a) as amended . . . requires a more context-specific approach that is based on an analysis of what the PTO actually did." This determination "will generally require an analysis of the record of the prior proceedings to determine if and how the examiner used the reference in making his initial decisions." This is a question of fact that will be reviewed for substantial evidence, but the ultimate question of whether a substantial new question of patentability exists is a question of law.Here, because the reference was "not evaluated as a primary reference that taught or made obvious the specific analytical method claimed," there was a substantial new question of patentability, and the grant of reexamination was proper.More detail of In re Swanson after the jump.This case involved an appeal from the Board of Patent Appeals and Interferences, which affirmed the Examiner's rejection of the claims of U.S. Patent 5,073,484 in a reexamination proceeding. The '484 patent discloses a method of quantitatively analyzing small amounts of biological fluids, such as milk, blood, and urine, or other solutions, to detect the presence of a particular substance called the analyte. Independent method claim 22 required the particular analyte be a member of a ligand-antiligand binding pair. The closest prior art was the Deutsch patent, which discloses a method of detecting ligand-antiligand binding pairs in order to determine the presence of a ligand in a biological fluid. During the initial examination of the application which matured into the '484 patent, the Examiner initially rejected all of the claims as being obvious under § 103 in light of various combinations of references which included the Deutsch patent. The claims were amended and then allowed. In 1998, the exclusive licensee of the '484 patent, Abbott Laboratories, sued Syntron Bioresearch for infringement of the '484 patent. Syntron counterclaimed that the claims were invalid in light of Deutsch. The jury found that Syntron failed to prove by clear and convincing evidence that the claims were anticipated or obvious. On appeal, the Federal Circuit affirmed the judgment of no invalidity for the '484 patent, and particularly, that Deutsch did not anticipate the claims. The court concluded that the jury verdict of no anticipation was supported by substantial evidence. The only issue regarding anticipation was whether Deutsch teaches "flowing said solution along the medium," and the court agreed that the jury reasonably could have found that Deutsch did not have this teaching. After the appeal, Syntron filed a reexamination request of the '484 patent, asserting a substantial new question of patentability based upon the Deutsch patent. Reexamination was granted, and the Examiner rejected the claims as being anticipated by Deutsch (and for other reasons). The Board affirmed the Examiner's rejection that Deutsch anticipated the claims. The Board rejected the patentee's argument that reexamination was improper because Deutsch does not raise a substantially new question of patentability as is required by 35 U.S.C. § 303. The Board found that Deutsch raised a substantially new question of patentability, despite having been cited in the original Office Action, because it was not cited in regard to the current claims (though the original claims were very similar) and was not relied upon for the same reason. The Board also dismissed the patentee's argument that Deutsch could not raise a substantial new question of patentability because a jury had affirmed a finding of validity over Deutsch, and the Federal Circuit had affirmed. The patent owner appealed the Board's decision to the Federal Circuit, raising as the only issue whether Deutsch raised a substantial new question of patentability.The Federal Circuit affirmed. The court first discussed the history of the reexamination statute. Any person may file a request for ex parte reexamination of an issued patent based upon prior art patents or printed publications. Congress intended reexaminations to provide an important "quality check" on patents that would allow the government to remove defective and erroneously granted patents. The PTO, however, may only grant a reexamination request if it determines that a substantial new question of patentability affecting any claim of the patent is raised by the request. 35 U.S.C. § 303(a) provides that "the existence of a substantial new question of patentability is not precluded by the fact that a patent or printed publication was previously cited by or to the Office or considered by the Office." The Federal Circuit acknowledged the district court and the Federal Circuit itself did consider "the precise question at issue on reexamination: whether Deutsch satisfies the 'flowing' limitation of the asserted claims and, thus, anticipates them." Both courts held the patents had not been proven invalid in light of Deutsch. Nevertheless, the Federal Circuit concluded that the statutory language, the legislative history, and different purposes underlying reexamination in federal court proceedings suggest that the determination of a substantial new question is unaffected by these prior court decisions.The court noted that the reexamination statute does not define what constitutes a "substantial new question of patentability." However, while the statute specifically discusses prior art references previously cited by or to the Patent Office of were considered by the Patent Office, the statute does not address any prior art citation or consideration by the courts. Thus, prior civil litigation was not a concern when Congress passed the reexamination statute or amended the statute. The focus on a "substantial new question of patentability" is what the Examiner considered at the time of the initial examination of the patent application, and not the issues addressed in prior civil litigation. The court noted examination procedures and civil litigation have different approaches in determining validity and on the same evidence could quite correctly come to different conclusions. This is because in litigation, the burden of proof is clear and convincing evidence (as a result of the presumption of validity), but in reexamination, there is no such presumption, and the examiner's burden is only a preponderance of the evidence. In addition, the examiner is conducting a subjective examination of the claims in light of the prior art, and giving the claims their broadest reasonable interpretation consistent with the specification. Based on all these differences in the nature of the proceedings, considering a validity issue in court is not equivalent to the PTO having had the opportunity to consider it. Therefore, even if the district court determines a patent is not invalid, the PTO is not prevented from finding a substantial new question of patentability based on the very same arguments made to a court. On the contrary § 303(a) requires analysis of what the PTO actually did during initial examination. As described by the court (internal citations omitted):

As the legislative history clarifies, to decide whether a reference that was previously considered by the PTO creates a substantial new question of patentability, the PTO should evaluate the context in which the reference was previously considered and the scope of the prior consideration and determine whether the reference is now being considered for a substantially different purpose.Determining the scope of an examiner's previous consideration of a reference will generally require an analysis of the record of the prior proceedings to determine if and how the examiner used the reference in making his initial decisions. As we believe that this inquiry is most accurately viewed as a question of fact, we will review the Board's findings regarding the scope of consideration of a reference during prior examinations for substantial evidence. However, the ultimate question of whether the reexamination is based on a substantial new question of patentability, in light of how a reference

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