(September 4, 2008), the Federal Circuit held that under 35 U.S.C. § 303(a), as amended in 2002, despite consideration of U.S. Patent No. 4,094,647 ("Deutsch") in the initial examination as a secondary reference for obviousness and in prior appellate decision on anticipation, there was a substantial new question of patentability regarding whether Deutsch anticipated and made obvious claims 22-25 that made reexamination warranted.
. . . we sustained the judgment that Deutsch did not anticipate the asserted claims, noting that "the burden having been on Syntron to prove by clear and convincing evidence that the claims were anticipated, we cannot conclude that the jury verdict on anticipation was not supported by substantial evidence."
. . . The district court and this court did consider the precise question at issue on reexamination: whether Deutsch satisfies the "flowing" limitation of the asserted claims and, thus, anticipates them. And both courts upheld the validity of the ’484 patent in light of Deutsch. Nevertheless, the statutory language, legislative history, and different purposes underlying reexamination and federal court proceedings suggest that the determination of a substantial new question is unaffected by these court decisions.
. . . We agree with the PTO’s current position. Section 303’s language and legislative history, as well as the differences between the two proceedings, lead us to conclude that Congress did not intend a prior court judgment upholding the validity of a claim to prevent the PTO from finding a substantial new question of validity regarding an issue that has never been considered by the PTO. To hold otherwise would allow a civil litigant’s failure to overcome the statutory presumption of validity to thwart Congress’ purpose of allowing for a reexamination procedure to correct examiner errors, without which the presumption of validity never would have arisen. See Patlex, 758 F.2d at 604 ("A defectively examined and therefore erroneously granted patent must yield to the reasonable Congressional purpose of facilitating the correction of governmental mistakes."). . . .
We, therefore, conclude the Board did not err in holding that the prior district court litigation did not prevent the Deutsch reference from raising a "substantial new question of patentability" under § 303(a). As properly interpreted a "substantial new question of patentability" refers to a question which has never been considered by the PTO; thus, a substantial new question can exist even if a federal court previously considered the question.
Surmodics also argues that Deutsch does not raise "a substantial new question of patentability" because Deutsch was considered by the PTO during the initial examination and relied on as a secondary reference for rejecting various dependent claims as obvious.
Surmodics recognizes that the 2002 amendment to § 303 overrides our prior rule in In re Portola Packaging, where we held that a reference could not raise "a substantial new question of patentability" if it was previously considered by the PTO in reference to the same or broader claims. It nevertheless urges this court to adopt a bright-line rule that "would preclude rejections in reexaminations based solely on references used in a rejection of claims in the original patent prosecution." Appellant Reply Br. 14. We decline the invitation. Such a rule would be plainly inconsistent with the clear text of the amendment. Section 303(a) now mandates 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." Thus, under § 303(a) as amended, a reference may present a substantial new question even if the examiner considered or cited a reference for one purpose in earlier proceedings. Nothing in the statute creates an exception to this rule for references considered in the context of a rejection of prior claims. Indeed, such an exception would overwhelm the rule and thwart a central purpose of the amendment, to overrule In re Portola Packaging. In that case, as here, the issue was whether a piece of prior art relied on for a prior rejection could nevertheless create a new question of patentability sufficient to warrant a reexamination. See In re Portola Packaging, 110 F.3d at 787-89. After the amendment to § 303, the answer to that question must be yes.
. . . 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. See H.R. Rep. No. 107-120, at 3 ("The 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."); see also 147 Cong. Rec. H5359 (statement of Rep. Berman) ("Ideally, a reexamination could be requested based on prior art cited by an applicant that the examiner failed to adequately consider . . . .").
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. See also H.R. Rep. No. 107-120, at 3 (stating that there should be "substantial evidence" that the examiner "did not properly understand the reference, or did not consider a portion of the reference in making his decision."). However, the ultimate question of whether the reexamination is based on a substantial new question of patentability, in light of how a reference was previously considered, remains a question of law, which we review de novo. While the standard is more flexible than before, we are mindful that Congress intended that the courts continue to "judiciously interpret the ‘substantial new question’ standard to prevent cases of abusive tactics and harassment of patentees through reexamination." H.R. Rep. No. 107-120, at 3.
We agree with the Board that whether Deutsch anticipates claims 22-24 raises a substantial new question of patentability under the amended § 303(a). Substantial evidence supports the Board’s conclusion that in the initial examination, "Deutsch was relied upon, as a secondary reference," for the limited purpose of "teaching immunoreactions in general, and not for the specific method steps claimed." In re Swanson, No. 2005-0725, Reexamination No. 90/006,785, at 18-19 (B.P.A.I. May 29, 2007). Deutsch was not evaluated as a primary reference that taught or made obvious the specific analytical method claimed. The independent claims, such as original claim 9, were found obvious without any reliance on Deutsch. Deutsch was cited only to reject the dependent claims that limited the analyte-reactant pair used in the method to a ligand-antiligand pair, e.g., original claim 10, or, more specifically, an antigen-antibody pair, e.g., original claim 11. Original Office Action at 9-10. The examiner explained that "it would be obvious that any known reaction within reasons [sic] could be incorporated in the modified method and apparatus of either Morison and [sic] Bauer" and cited to Deutsch as one of three references that disclosed immunoreactions. Id. In other words, since Deutsch and the other secondary references taught immunoreactions, immunoreactions were one type of "known reaction" that could be adopted to the method made obvious for any known reaction (within reason) by Morison and Bauer. Nowhere in its decision did the examiner consider the particular analytical method disclosed by Deutsch.
In light of the extremely limited purpose for which the examiner considered Deutsch in the initial examination, the Board is correct that the issue of whether Deutsch anticipates the method disclosed in claims 22, 23, and 25 was a substantial new question of patentability, never before addressed by the PTO.6
footnote 6 - In reaching this holding, we do not rely on the fact, discussed by the Board, that claim 22 differed from the rejected claims in the initial patent. While the difference between rejected claims and the claims at issue during a reexamination may be relevant to whether there is a substantial new question of patentability, a change in the scope of a claim will not, in itself, make all questions of patentability of the revised claim "substantial new question[s]." As the limited scope of the examiner’s consideration of Deutsch is sufficient to find that anticipation by Deutsch raises a substantial new question of patentability, we need not consider what effect the change in scope of the claims would have had had Deutsch been more fully considered during the initial proceeding.