By Kevin E. Noonan --
The Federal Circuit clarified the role of the written description requirement in interference practice today in an opinion by Judge Rader, one of the Court's most severe critics of its written description jurisprudence. Unlike the situation where the written description requirement is used to invalidate patents (which is the subject of a petition for en banc review in Ariad v. Eli Lilly), Judge Rader's decision confirms that the written description requirement is particularly relevant to the essential interference question of inventive priority.
The interference at issue was declared against U.S. Patent No. 6,513,968 to Schembri and assigned to Agilent, and U.S. Patent Application Serial No. 10/619,244 to Besemer and assigned to Affymetrix. Affymetrix provoked the interference by copying claims from the '968 patent; because Affymetrix's application was awarded the earliest priority date, Besemer was declared the senior party, placing the burden of establishing priority on Agilent.
The interference count was identical to claim 20 of the Schembri patent and claim 66 of the Besemer application:
providing a first substrate and a second substrate having inner surfaces that define a closed chamber therebetween, said chamber adapted to retain a quantity of fluid so that the fluid is in contact with both inner surfaces, and wherein at least one of said inner surfaces is functionalized with polynucleotides, polypeptides, or polysaccharides;
introducing a fluid containing a plurality of components into the closed chamber so as to provide a quantity of fluid therein in contact with both inner surfaces;
providing a bubble in the fluid; and
moving a bubble within the fluid to result in mixing.
As explained in the opinion, Agilent's Schembri patent disclosed a microarray hybridization method performed in a closed chamber in which probe sequences were attached to one or both of two opposing surfaces on the interior of the chamber. Because of the small volumes of fluid used for hybridization, mixing was effected by producing bubbles in the fluid (by heating) and using motion of the bubbles in response to a temperature gradient to "cause the bubble to move and mix the fluid sample in the closed chamber," as illustrated in Figures 1 and 4 of the '968 patent:
The Besemer application, on the other hand, disclosed microarrays contained in a chamber operably linked to "circulator" embodiments comprising reservoirs from which hybridization fluid was pumped through the hybridization chamber to effect mixing, as illustrated in Figure 28 (at right).
Alternatively, the microarrays were contained in a chamber that was agitated at 3000 cycles per minute as shown in Figure 29 (at left).
During interference proceedings in the Patent Office, Agilent challenged the Besemer claim in interference for failure to satisfy the written description requirement of 35 U.S.C. § 112, first paragraph. The Board disagreed on the grounds that "Schembri had not advanced any 'meaningful evidence' to show that one of ordinary skill in the art would not have understood Besemer's specification to inherently disclose using bubbles to mix fluid in a closed chamber, as required by Besemer's claim 66. Board Decision, slip op. at 28," awarded priority to the Besemer application and cancelled Schembri's '968 patent. Agilent appealed, filing an action in the District Court for the Northern District of California pursuant to 35 U.S.C. § 146. In that action, both parties submitted new expert reports concerning the disclosures of the '968 Schembri patent and the Besemer application. After holding a claim construction hearing and considering summary judgment motions from both parties, the District Court affirmed the Board's decision that the Besemer application satisfied the written description requirement. Agilent then appealed to the Federal Circuit, challenging the District Court's claim construction and written description determinations.
The opinion, written by Judge Rader and joined by Judge Mayer and 7th Circuit Judge Richard Posner, sitting by designation, began by considering the question of which specification was to be used to construe Besemer's claim 66. The District Court had used the disclosure of the Besemer application (termed "the host application" in the opinion), and Agilent contended that the proper reference was the Schembri patent specification. Judge Rader framed the question in terms of which of the Court's precedents were controlling: In re Spina or Rowe v. Dror. In the Spina case, as here, an applicant copied a claim from an issued patent to provoke an interference. The Board, in determining whether the copier's specification satisfied the written description requirement, construed the copied claim in light of the specification of the granted patent, an approach affirmed by the Federal Circuit: "'[w]hen interpretation is required of a claim that is copied for interference purposes, the copied claim is viewed in the context of the patent from which it was copied.' Spina, 975 F.2d at 856."
In the Rowe case, junior party Rowe copied claims from the Dror patent to provoke an interference. In that case, senior party Dror moved for judgment on the grounds that a third-party patent anticipated certain of Rowe's claims corresponding to the count. In deciding the subsequent appeal, the Federal Circuit held that the specification of Rowe's application should be used to construe the claim term at issue -- in other words, precisely the opposite result from the rule laid down in Spina. That panel recognized the inconsistency with the Spina panel's rule, and distinguished the cases as follows:
In this case, the Federal Circuit held that the rule in Spina applies, because the question was whether "Besemer ha[s an] adequate basis to copy Schembri's claim and thereby challenge Schembri's priority of invention . . . . This case does not present the Rowe situation, 'where the issue is whether the claim is patentable to one or the other in light of prior art.'" In making this determination, the Court expressly rejected Affymetrix's contention that it would be contrary to 37 C.F.R. § 41.200(b), stating that "administrative regulations cannot trump judicial directives . . . . Judicial precedent is as binding on administrative agencies as are statutes" (citing Rowe at 479 n.2). The Court summarized its holding on this question as follows:
Turning to the District Court's claim construction, the panel disagreed with two aspects that were dispositive. First, the panel disagreed with the District Court's construction of the claim term "a closed chamber . . . adapted to retain a quantity of clued" to mean "an enclosed cavity, or some other enclosure or system of enclosures, which is capable of being sealed or set apart from its surroundings to retain a quantity of fluid." Under the District Court's construction, the configuration set forth in Figure 28 of the Besemer application provided an adequate written description of a "closed chamber," as illustrated at left.
The Federal Circuit held that this construction was "dubious" since it ran counter to the plain meaning of the phrase "a closed chamber" considered in the context of the rest of the claim, which recited that the closed chamber was "'define[d by] a first substrate and second substrate having inner surfaces." The Court contrasted the chamber thus recited as being "bounded by two discrete substrates" with "a nebulous space that could ambiguously span 'a system of enclosures.'" The panel's contrary construction of the term was supported by the Schembri specification, rather than the Besemer specification used by the District Court. As might be expected, the definition of "a closed chamber" in the Schembri specification provided no support for the embodiments disclosed in the Besemer specification. The Federal Circuit also found functional as well as structural distinctions, including that the "closed chamber" disclosed in the Schembri specification was configured so that nucleated bubbles would be formed that would move in response to an induced temperature gradient to facilitate mixing, in contrast to the embodiments disclosed in the Besemer specification that used fluid flow from external reservoirs to mix hybridization fluid over the microarray surfaces. The Court's opinion also noted that construing "a chamber" to comprise "several chambers" (as would be required to encompass the Besemer embodiments) would "provide no guidance as to where, amongst the several chambers, the first and second substrates [comprising the probe sequences] are located." In this regard, the CAFC also held that the District Court's construction was faulty for rendering the word "closed" to be superfluous, finding that the term "closed" was synonymous with "sealed," a quality the embodiments disclosed by Besemer did not have.
Turning to the written description issue, the panel agreed with Agilent that there was no support in the Besemer specification for the count corresponding to Besemer's copied claim 66. Summarizing, the opinion states that:
The panel eliminated the embodiments disclosed in Figures 28 and 30 for failure to describe a closed chamber, and then eliminated the embodiment disclosed in Figure 29 for failure to disclose bubbles to facilitate mixing. The panel's conclusions were based on the Court's reading of portions of the Besemer specification as well as expert testimony, which the opinion termed "a critical admission" that the vortexer embodiment described in Figure 29 did "not necessarily" generate bubbles in operation, testimony that the Court opined vitiated any inherency argument asserted by Affymetrix.
The Federal Circuit also held that the District Court had improperly failed to consider new evidence presented by Agilent pursuant to the provisions of 35 U.S.C. § 146, directed at supplying what the Board found it had failed to supply during the interference:
The District Court erred in not considering Agilent's new evidence and thus deferring to the Board's factual determinations. Accordingly, the panel held that there was "no dispute of material fact that the Besemer application does not teach the claimed method" and thus the Besemer application was entitled to a priority date no earlier than its filing date. Accordingly, the Federal Circuit held that Agilent was entitled to priority without remand to the District Court.
Panel: Federal Circuit Judges Mayer and Rader and Seventh Circuit Judge Posner
Opinion by Circuit Judge Rader
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