By Kevin E. Noonan --
Re-examination, whether ex parte under 35 U.S.C. § 302-307 or inter partes under 35 U.S.C. § 311-318, is a procedure intended to provide an alternative to patent litigation, which Congress characterized as being expensive and inefficient in passing legislation establishing these two routes of post-grant challenge (see H.R. Rep. No. 107-120 (2002)). Perhaps unexpectedly, both avenues have been increasingly used during litigation, as a way to limit the scope of asserted claims, invalidate patents-in-suit altogether, and provide leverage towards settlement. In some instances, re-examination requesting defendants have been able to obtain a stay in the underlying litigation pending completion of Patent Office review, although this is far from being the general or even a frequent occurrence.
The scope of re-examination has also been expanded by statute, specifically a revision meant to overturn the Federal Circuit's decision in In re Portola Packaging Inc., 110 F.3d 786 (Fed. Cir. 1997). In that case, the Court found it improper to base the existence of a substantial new question of patent validity on a reference that had been considered during initial ex parte examination. In Portola Packaging, although the reference was the same, the ground of rejection asserted was different, being an obviousness rejection based on a combination of the previously-considered reference and a newly-applied reference. Congress disagreed with this interpretation of the statute (H.R. Rep. No 107-120, at 2):
[T]he appropriate test to determine whether a "substantial new question of patentability" exists should not merely look at the number of references or whether they were previously considered or cited but their combination in the appropriate context of a new light as it bears on the question of the validity of the patent.
In effectuating this change, amended section 303(a) as follows (the amendment appears in italics):
(a) Within three months following the filing of a request for reexamination under the provisions of section 302 of this title, the Director will determine whether a substantial new question of patentability affecting any claim of the patent concerned is raised by the request, with or without consideration of other patents or printed publications. On his own initiative, and any time, the Director may determine whether a substantial new question of patentability is raised by patents and publications discovered by him or cited under the provisions of section 301 of this title. 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 extent to which "old" art qualifies in support of establishing a substantial new question of patentability sufficient to declare an interference was further clarified on Thursday, when the Federal Circuit issued its decision in In re Swanson. Swanson was the result of a re-examination requested by a litigant, Syntron Bioresearch Inc., that had failed to establish invalidity as an affirmative defense in a patent infringement lawsuit brought by the '484 patent's licensee, Abbott Laboratories (Abbott Labs. v. Syntron Bioresearch, Inc., No. 98-CV-2359 (S.D. Cal. Oct. 12, 2001)). The judgment of the trial court was affirmed by the Federal Circuit (Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343 (Fed. Cir. 2003)). Not to be deterred, however, Syntron filed a request for re-examination of the '484 patent, which was granted by the U.S. Patent and Trademark Office as Reexamination Serial No. 90/006,785.
The patent-in-reexamination, U.S. Patent No. 5,073,484, claimed methods for analyzing a biologically-relevant analyte present in biological fluids such as "milk, blood, urine" and the like, wherein a bound reactant is immobilized on a test strip in "reaction zones," and the analyte-containing fluid is motivated through the strip. The presence of an analyte specific for a reactant in a reactant zone is detected by a reaction, preferably a color change that can be seen in each of the zones on the strip. Claim 22 of the '484 patent was specifically at issue in the re-examination:
22. A method for analysis of an analyte which is a member of a ligand-anti-ligand binding pair in a test solution comprising the steps of:
(a) providing a non-diffusively immobilized reactant in each of one or more reaction zones spaced successively along a flow path defined by a liquid permeable medium, wherein said reactant is the other member of said binding pair and is capable of binding with the analyte to form a predetermined product;
(b) flowing said solution along the medium and sequentially through the reaction zone(s); and
(c) detecting the presence of analyte, said reactant or said predetermined product in the reaction zone(s), wherein the number of zones in which detection occurs is related to the presence [sic] of analyte solution.
Three dependent claims, reciting detection by a detectable chemical moiety (claim 23), an enzyme (claim 24), or a radioisotope (claim 25) were also at issue.
Several prior art references were asserted against the claims of the '484 patent, including one, U.S. Patent No. 4,094,647 ("Deutsch") that had been considered during ex parte examination and had been asserted in support of Syntron's failed attempt to establish that the '484 patent was invalid at trial. The Patent Office in the re-examination rejected claims 22-25 as being anticipated by the Deutsch patent, a determination affirmed by the Board and challenged by Abbott in the appeal. In addition to affirming the Examiner's rejection of these claims under 35 U.S.C. § 102(b), the Board also rejected the patentee's contention that reexamination was improper because the Deutsch reference could not raise a substantial new question of patentability because it had been before the Examiner during ex parte examination. The reference did raise a substantial new question of patentability, according to the Board, "because it was not cited in regard to the presently rejected claims and it was not relied upon for the same reason the examiner now relied upon it."
The Federal Circuit limited its review to this last question, since the Board's determination based in alternative prior art was not challenged by the patentee. In an opinion by Judge Gajarsa, joined by Judges Lourie and Bryson, the Court also rejected the patentee's argument that the Patent Office was precluded from declaring a re-examination based on the Deutsch reference. The Court characterized this case a "case of first impression," since the scope of available prior art in re-examination had not been considered since Congress amended the statute to overturn Portola Packaging.
The opinion first considered the effect of the District Court decision that the third party re-examination requestor had not established that the claims were invalid over the Deutsch reference. The CAFC rejected the patentee's contention that the District Court decision had any effect on the question of whether Deutsch could be used to establish a substantial new question of patentability, citing the language of the statute itself, the legislative history, and the "different purposes underlying reexamination and federal court proceedings." First, the Federal Circuit turned to the newly-added language of the amendment, which was focused on art previously cited to or considered by the Patent Office and does not include any art previously cited in court proceedings. The legislative history was in agreement, according to the Court, because it suggested that Congress was solely interested in how these issues were to be considered by the Office and not in civil litigation. This interpretation was consistent with the statutory mandate that re-examination be performed using the same standards as the initial ex parte examination. This included a lack of any presumption of validity, a preponderance of the evidence burden of proof, and giving claim terms the broadest possible interpretation, both features of Patent Office examination that distinguish it from litigation. Even in the context of civil litigation, "a prior holding of validity is not necessarily inconsistent with a subsequent holding of invalidity," according to the opinion, citing Stevenson v. Sears Roebuck & Co., 713 F.2d 705, 710 (Fed. Cir. 1983), "and is not binding on subsequent litigation or PTO reexaminations," citing Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1429 and n.3 (Fed. Cir. 1988). Indeed, the CAFC cited Ethicon for the proposition that "if the district court determines a patent is not invalid, the PTO should continue its reexamination because, of course, the two forums have different standards of proof for determining invalidity" (see Ethicon, 849 F.2d at 1428-29). The Court concluded that the PTO's position was correct, because otherwise Congressional intent could be "thwarted" by a litigant's failure to sustain its burden of establishing invalidity by clear and convincing evidence, which is too high a standard for Patent Office action. Since this heightened burden was a consequence of the presumption of validity, it would be improper to effectively transfer this burden to Patent Office proceedings directed to whether a patentee's claims rightfully enjoyed the presumption.
The fact that the Deutsch patent was considered during ex parte examination resulting in the '484 patent was also not sufficient to preclude a Patent Office finding of a substantial new question of patentability, according to the Federal Circuit. Such a conclusion would be clearly contrary to the express terms used in the statute and clearly be contrary to the intent of Congress to overrule the Portola Packaging decision, in the Court's view. The CAFC also outlined the contours of what could not be used to raise a substantial new question of patentability: "[a]s was true before the amendment, an 'argument already decided by the Office, whether during the original examination or an earlier reexamination' cannot raise a new question of patentability," citing H.R. Rep. No. 96-1307 and In re Recreative Technologies Corp., 83 F.3d 1394, 1396-97 (Fed. Cir. 1996). The Court cites the context of prior Patent Office consideration as being one dispositive question: "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," citing H.R. Rep. No. 107-120, at 3.
Since the Federal Circuit considered such contextual questions to depend on a consideration of "if and how the examiner used the reference in making his initial decisions" and that this constituted a question of fact, it reviewed for substantial evidence. Using this standard, the CAFC found that the Board had substantial evidence supporting its determination that the Deutsch reference, in the context of the reexamination, raised a substantial new question of patentability (the ultimate question remaining one of law reviewed de novo). The Court said that the Board properly considered that Deutsch had been considered no more than a secondary reference during initial examination, and was not specifically applied to the pending claims. The difference in how the Deutsch reference was used in the reexamination, as a primary reference asserted as anticipating claims 22-25, was enough that it raised a substantial new question of patentability that had not been considered during initial examination.
Although the "context" requirement is also not expressly found in the statutory language, its effects are consistent with the use of previously-considered prior art in Portola Packaging, insofar as the art was used in both Portola and here to raise a patentability issue not previously considered by the Examiner. This decision further expands the capacity for art, previously cited or not, to be used to support a reexamination request, and makes it easier for a third party, especially a litigant, to use the reexamination statute to her advantage. Arguably, that was exactly what Congress had in mind.
In re Swanson (Fed. Cir. 2008)
Panel: Circuit Judges Lourie, Bryson, and Gajarsa
Opinion by Circuit Judge Gajarsa
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