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December 29, 2006
Dispensing Claim Construction
Ventana
Medical Systems sued BioGenex Labs for infringing
6,352,861, which claimed automated staining of microscope slides. The
asserted stain didn't take well in claim construction: the district court found
non-infringement based on a narrow construction disclosed throughout the patent
and in prosecution history. By 2-1, the CAFC majority used a different microscope (CAFC
06-1074), though the
dissent concurred with the district court decision. Here, in a
turnabout from previous rulings, where claims would not be construed broader
than the disclosed embodiments, or broader than envisioned by the inventors, the
appeals court muddies the tenets of claim construction.
Judges Prost and DKY formed the majority opinion, with Judge Lourie dissenting.
A single claim term, "dispensing", specifically of reagents onto a slide, was the dispenser of contention. The district court had narrowly construed the term "dispensing" to only direct dispensing, based upon prosecution estoppel disparaging "sip and spit" dispensing, that is, using an intermediate transport, such as a pipette; thus forcing Ventana to appeal in an attempt to recover lost ground. The issue though, is whether that ground should have been Ventura's to recover.
The district court construed the “dispensing” claim limitation to require “direct dispensing,” meaning that “the reagent is dispensed directly from the reagent container” onto the slide, rather than utilizing an intermediate transport mechanism to transfer reagent from the reagent container to the slide. Claim Construction Order, slip op. at 5-7. The district court held that the context in which the “dispensing” term is used in the claim “necessitates ‘direct dispensing’ by stating that the reagent in the reagent container is dispensed onto the slide, meaning the reagent is dispensed directly from the reagent container.” Id., slip op. at 6. The district court also noted that the written description and figures supported a narrow construction of “dispensing” because all of the disclosed embodiments dispense reagent directly from the bottom of the reagent container without using any intermediate transfer device. Id., slip op. at 7.
After construing the term “dispensing” to mean “direct dispensing,” the district court held that the inventors disclaimed a particular type of dispensing, “sip and spit” dispensing, during the prosecution of an ancestor application. In “sip and spit” dispensing, an intermediate transport mechanism such as a pipette uses suction to “sip” the reagent from the reagent container and then releases or “spits” the reagent onto the slide.
The CAFC majority refused to apply prosecution estoppel of the parent to continuation children, and refused to limit method claims where only direct dispensing embodiments had been disclosed, but that aspect of dispensing was not part of the claims.
During prosecution, the examiner had rejected parent claims as unpatentable over prior art.
In response, the inventors argued that neither the Wakatake nor the Assmann reference disclosed the capability to dispense reagent “directly to a sample”.
The district court held that these statements during prosecution amounted to a “clear and unmistakable” disclaimer of “sip and spit” dispensing...
While this disclaimer had been applied to a parent application, the argument did not reappear during prosecution of children. The majority opinion was that sins of the father are not necessarily visited upon the children.
BioGenex thus raises the doctrine of prosecution disclaimer. “[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Phillips, 415 F.3d at 1317. Accordingly, we examine the patent’s prosecution history, when placed in evidence, to determine whether the inventor disclaimed a particular interpretation of a claim term during the prosecution of the patent in suit or during the prosecution of an ancestor application. Id.; Advanced Cardiovascular Sys. v. Medtronic, Inc., 265 F.3d 1294, 1305-06 (Fed. Cir. 2001). But the doctrine of prosecution disclaimer generally does not apply when the claim term in the descendant patent uses different language. Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1078 (Fed. Cir. 2005) (“[T]he prosecution of one claim term in a parent application will generally not limit different claim language in a continuation application.”); ResQNet.com, Inc. v. Lansa, Inc., 346 F.3d 1374, 1383 (Fed. Cir. 2003) (“Although a parent patent’s prosecution history may inform the claim construction of its descendant, the [parent] patent’s prosecution history is irrelevant to the meaning of this limitation because the two patents do not share the same claim language.”); Advanced Cardiovascular Sys., 265 F.3d at 1305-06.
In this case, the allegedly disclaiming statements were made with respect to claim language that expressly required reagent in the reagent container to be “dispensable directly to a sample.” Indeed, in distinguishing the prior art, the inventors stated that the prior art “sip and spit” devices lacked “the present invention’s novel capability to dispense reagent ‘directly to a sample’ as set forth in Applicants’ Claim 1, at line 16” (emphasis added). Because claims 1 and 5 of the ’861 patent use different claim language—that is, they do not require that reagent be “dispensable directly to a sample”—the alleged disclaimer of “sip and spit” dispensing during the prosecution of the ’052 application does not apply to the asserted claims of the ’861 patent.
There was some prosecution history of a child application that was latched onto for the broader claim construction of "dispensing" as including "sip and spit" dispensing.
Indeed, we agree with Ventana that the prosecution history of the ’861 patent supports a broad construction of “dispensing.” For example, during the prosecution of the application that led to the ’861 patent, the examiner issued a restriction requirement. With respect to the application claims that eventually resulted in claims 1 and 5 of the ’861 patent, the examiner observed that “the process as claimed can be practiced by another materially different apparatus or by hand, such as a manual pipette means.” This statement shows that the patent examiner did not consider the “dispensing” claim term to be limited to the “direct dispensing” embodiment disclosed in the specification. Moreover, the inventors did not rely on “direct dispensing” as a distinction between the claims at issue in this case and the prior art. Instead, in response to rejections over the prior art, the inventors limited their arguments to the ability of the claimed inventions to address the shortcomings of manual reagent identification and manual determination of reagent dispensing protocols.
As to the specification -
To start with, claims 1 and 5 do not contain any language that could be read to limit the term “dispensing” to require “direct dispensing.” Although “direct dispensing” is one type of dispensing, BioGenex does not appear to dispute that other types of dispensing, such as “sip and spit” dispensing, also fall within the ordinary meaning of “dispensing.”
Claim terms “‘are generally given their ordinary and customary meaning.’” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). And “the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art.” Id. at 1313. In this case, Ventana argues that there is nothing in the record to suggest that a person of ordinary skill in the art would interpret the disclosure and claims of the ’861 patent to mean that the term “dispensing” is limited to “direct dispensing.” We agree.
BioGenex argues that the patent’s specification compels a narrow construction of “dispensing.”... We decline to interpret these general statements by the inventors to effect a complete surrender from the claims of the ’861 patent of all types of dispensing except “direct dispensing.”...
[T]his is not a case in which the inventor’s distinguishing the invention over the prior art in the specification results in a disavowal of coverage by the inventor of features in the prior art. In Phillips, we recognized that in certain cases, “the specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor.” Phillips, 415 F.3d at 1316. In such cases, this court interprets the claim more narrowly than it otherwise would to give effect to the inventor’s intent to disavow a broader claim scope. Id.; Honeywell Int’l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1319-20 (Fed. Cir. 2006); SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1342-44 (Fed. Cir. 2001). Here, however, BioGenex points to only general statements by the inventors indicating that the invention is intended to improve upon prior art automated staining methods: “The previously known devices are limited in their performance and unable to satisfy the needs for automated, high precision immunohistology. It is an object of this invention to provide a device which provides more rapid, reliable and more reproducible results than standard methods . . . .” ’861 patent, col. 2, ll. 26-31. Such general statements, without more, will not be interpreted to disclaim every feature of every prior art device discussed in the “BACKGROUND ART” section of the patent.
BioGenex submits that when the specification is read in its entirety, one of skill in the art would come to the “inescapable conclusion that the novelty of Ventana’s invention is the birthday cake or over/under carousel arrangement for direct dispensing.” As a result, BioGenex argues, the specification has implicitly defined the term “dispensing” to mean “direct dispensing.”
There are, however, several problems with this argument. “It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to which the patentee is entitled the right to exclude.’” Phillips, 415 F.3d at 1312 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). “[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.” Id. at 1323. While the fact that the disclosed embodiments are limited can assist in interpreting claim language, the mere fact that the ’861 patent discloses embodiments in which the reagent container is also the reagent dispenser does not in and of itself mean that the method claims at issue are limited to the disclosed embodiments.
The second problem with BioGenex’s argument is that each claim does not necessarily cover every feature disclosed in the specification. When the claim addresses only some of the features disclosed in the specification, it is improper to limit the claim to other, unclaimed features. Id. at 1327; see also Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1331 (Fed. Cir. 2004) (“[P]atentees [are] not required to include within each of their claims all of [the] advantages or features described as significant or important in the written description.”); E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1370 (Fed. Cir. 2003) (“An invention may possess a number of advantages or purposes, and there is no requirement that every claim directed to that invention be limited to encompass all of them.”). Here, the claims of the ’861 patent are directed toward automated methods of dispensing that use bar codes to determine which reagents should be dispensed onto which slides. Although the preferred embodiments also contain a “direct dispensing” feature, the inventors were not required to claim this feature in the ’861 patent and, indeed, did not do so.
So, vacating the narrowed construction, the majority remanded.
Judge Lourie, in a strongly reasoned dissent, argued that the Arizona district court had got it right.
“[T]he person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). The specification “is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.” Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). When read in the context of the specification, the claim term “dispensing” clearly means “direct dispensing.”
The ’861 patent is part of a family of six other patents sharing a common specification, although only claim 15 of the ’707 patent expressly recites “direct dispensing.” Claim 1 of application 07/924,052, which eventually was abandoned, was amended to include the word “direct dispensing” in order to overcome prior art. Claim 1 of the ’861 patent is broader and makes no reference to dispensing directly. Nonetheless, the claims must be construed in light of the specification, which is the same for all seven patents and which repeatedly describes dispensing reagent directly from a reagent container onto a slide.
[The summary of the invention] describe[s] the essence of the invention and clearly show that the reagent is dispensed directly from a reagent container positioned in a support onto a slide... Such statements are repeated throughout the rest of the specification... Statements describing dispensing reagent directly from a reagent container onto a slide are thus found in the abstract, the summary of the invention, the detailed disclosure of the invention, and the figures. Those statements do not merely describe a preferred embodiment of the invention; they broadly disclose the overall invention of all seven patents. The majority points out that, because the preferred embodiment discloses direct dispensing, we should not limit the claims to only that which is the disclosed embodiment. However, this is not a case of limiting the claims by looking at a preferred embodiment. Direct dispensing is the essence of the invention, and the specification supports that conclusion. The specification, shared by all seven patents, leads to the “inescapable conclusion” that the invention of the ’861 patent consists of “direct dispensing.” Microsoft Corp. v. Mult-Tech Sys., Inc., 357 F.3d 1340, 1348 (Fed. Cir. 2004) (citing SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1342 (Fed. Cir. 2001)). Moreover, nowhere does the specification suggest that the invention includes the alternative “sip and spit” dispensing method, involving dispensing reagent from an upright container by means of a pipette. Accordingly, I believe that the district court correctly construed the claims to require “direct dispensing.”
An examination of the prosecution history confirms that Ventana viewed its inventions as limited to direct dispensing. In a related grandparent application, in order to overcome an examiner’s rejection, Ventana argued that the prior art lacked the “present invention’s novel capability to dispense reagent ‘directly to a sample’” and that the “apparatus of the present invention” uses a reagent carousel and reagent container supports, “which minimize the time required to apply a given reagent, and the time between the application of multiple reagents, by dispensing reagent ‘directly to a sample.’” Ventana further stated: “As can be seen in the Figures, the reagent carousel is positioned above the samples and the reagent containers are oriented within the carousel with their outlet nozzles pointing down such that they are ready to dispense reagent directly to the sample below.” Those statements made in the prosecution of the related patent application, having the same specification, reflect that Ventana understood its own invention to be limited to direct dispensing. We cannot construe the claims to cover subject matter broader than that which the patentee described in its specification, regarded as comprising its invention, and represented to the Patent and Trademark Office.
Even though those statements from the prosecution were made in a grandparent patent application, they relate to the common specification and reflect Ventana’s own understanding of its invention. I believe, therefore, that the statement in the prosecution of the ’052 application is indicative of the proper interpretation of the same claim term in the later-issued ’861 patent.
Posted by Patent Hawk at December 29, 2006 11:04 PM | Claim Construction