## United States Court of Appeals for the Federal Circuit

06-1074

VENTANA MEDICAL SYSTEMS, INC., Plaintiff-Appellant,

v.

BIOGENEX LABORATORIES, INC., Defendant-Appellee.

Ron E. Shulman , Wilson Sonsini Goodrich & Rosati , of Palo Alto, California, argued for plaintiff-appellant. With him on the brief were Roger J. Chin , and Nicole W. Stafford , of Austin, Texas. Peter B. Goldman , Leonard Felker Altfeld Greenberg & Battaile, P.C., of Tucson, Arizona, argued for defendant-appellee. With him on the brief were Jeffrey H. Greenberg and Lorenzo B. Cellini

. Appealed from: United States District Court for the District of Arizona Judge Raner C. Collins

## United States Court of Appeals for the Federal Circuit

06-1074

VENTANA MEDICAL SYSTEMS, INC., Plaintiff-Appellant,

v.

BIOGENEX LABORATORIES, INC., Defendant-Appellee.

__________________________ DECIDED: December 29, 2006

__________________________ Before LOURIE, DYK, and PROST, Circuit Judges

. Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge LOURIE. PROST, Circuit Judge

. Plaintiff-Appellant, Ventana Medica l Systems, Inc. (“Ventana”) appeals the decision of the United States District Court for the District of Arizona granting judgment of noninfringement of U.S. Patent No . 6,352,861 (the “’861 patent”) in favor of Defendant-Appellee, BioGenex Laboratories, Inc. (“BioGenex”). Because the district court erred in its claim construction, we vacate the judgment of noninfringement and remand for further proceedings.BACKGROUND Ventana is the owner of several pat ents relating to automated methods and apparatuses for staining microscope slides. Such methods and apparatuses may be used, for example, to detect diseases in the tissues of patients. In a process known as immunostaining, pathologists first mount ti ssue samples on microscope slides. The slides then undergo a series of treatment steps including the application of various reagents such as antibody stains. Each of these treatment st eps is separated by multiple rinse steps, during which unreact ed reagents are removed from the slides. Finally, the stained slides are examined by pathologists to detect the presence of diseases. At issue in this case is Ventana’s ’861 patent, entitled “Automated Biological Reaction Apparatus.” As the title s uggests, the ’861 patent claims automated apparatuses and methods used to perform a variety of biological assays, including immunostaining. The ’861 patent stems from the same origi nal patent application as six other patents assigned to Vent ana: U.S. Patent No. 5,595, 707 (the “’707 patent”); U.S. Patent No. 5,650,327 (the “’327 patent”); U.S. Patent No . 5,654,199 (the “’199 patent”); U.S. Patent No. 5,654,200 (the “’200 patent”); U.S. Pa tent No. 6,827,901 (the “’901 patent”); and U.S. Patent No . 6,943,029 (the “’029 patent”). All seven of these patents share a common specification. The common specification discusses various previously known automated staining devices and asserts that such prior art devices “are limited in their performance and unable to satisfy t he needs for automated, high precision immunohistology.” ’861 patent, col. 2, ll. 26-28. To overcome these problems, the inventors of this family of patents sought to

06-1074 2provide a device which provides more rapid, reliable and more reproducible results than standard methods; can perform any standard immunochemical assay . . . ; pref orms [sic] all steps of the immunohistochemical assay irrespective of complexity or their order, at the time and temperature, and in the environment needed; and is cost effective in terms of equipment, reagent and labor costs. ’861 patent, col. 2, ll. 29-38. The common specification discloses an automated slide staining apparatus possessing multiple features, and each of Ventana’s seven patents claims various combinations of these features and methods related to these features. For example, the ’327 patent is entitled “Method for Mixing Reagent and Sample Mounted on a Slide” and the claims relate to methods that use streams of gas to st ir the reagents on the slide surface. In contrast, the claims of the ’861 patent relate to automated dispensing systems that employ bar c ode-labeled reagent containers and/ or slides. As described in the patent specification, [b]ar code reader 231 (FIG. 14) above slide 205 reads a slide bar code 233 (FIGS. 13 and 17) on each slide. The slide bar codes [sic] 233 identifies the slide sample and t he particular immunohistochemical process required for that sample. This information is fed into the computer and correlated with the indexed position of that slide with respect to “home”, to control the sequence of r eagent chemicals to be applied to that slide in the reagent application zone. ’861 patent, col. 9, ll. 48-55. The specif ication further discloses that the reagent containers may also be labeled with bar codes: A reagent bar code reader 346 can be mounted on post 302, positioned to scan a reagent bar code 348 on the reagent bottle 12. Bar code 348 identifies the contents of the reagent bottle. At the beginning of a slide treatment operation, the reagent carousel 10 is rotated past the bar code reader 346, and the bar code 348 on each reagent bottle 12 is scanned. The scanned information is fed to t he computer and correlated with the indexed position of the r eagent carousel 10. This information is used to rotate the reagent carousel 10 to plac e the correct reagent bottle 12 in the application zone for each slide treatment step for each slide.

06-1074 3Id. , col. 12, ll. 28-38. BioGenex manufactures and sells automat ed staining devices. On February 11, 2003, Ventana filed suit against BioGenex alleging infringement of claims 1, 2, 3, 5, 6, and 8 of the ’861 patent. T he district court held a Markman hearing and construed certain disputed claim terms in a written opinion. Ventana Med. Sys., Inc. v. BioGenix [sic] Labs., Inc. , No. 03-CV-92, slip op. at 1-17 (D. Ariz. Aug. 23, 2005) (“ Claim Construction Order ”). In light of the district cour t’s construction of the claim term “dispensing,” which appears in all of the asserted claims, Ventana stipulated to a judgment of noninfringement and re served its right to appeal the district court’s claim construction. Accordingly, the district c ourt entered a final judgment of noninfringement. Ventana Med. Sys., Inc. v. BioGenex Labs., Inc. , No. 03-CV-92, slip op. at 1-2 (D. Ariz. Oct. 4, 2005). Ventana now appeals. DISCUSSION
I The sole issue on appeal is the proper construction of the claim term “dispensing” in asserted claims 1, 2, 3, 5, 6, and 8 of the ’861 pat ent. Of the asserted claims, claims 1 and 5 are independent. Both cover “[a] method of dispensing reagents onto a slide.” Claim 1 reads: 1. A method of dispensing reagents onto a slide, the method comprising the steps of: providing at least one reagent container; providing at least one slide on a slide support; automatically identifying the reagent container using a computer; automatically determining whether r eagent in the reagent container should be dispensed onto the slide; and dispensing the reagent in the reagent c ontainer onto the slide based on the determination of whether the r eagent in the reagent container should be dispensed onto the slide,

06-1074 4wherein the step of aut omatically determining whether reagent in the reagent container should be dispensed onto the slide includes the steps of: providing a bar code reader; reading a slide bar code placed on t he slide using the bar code reader thereby acquiring slide information, the slide information indicating reagents to be applied to the slide; and sending the slide information to the computer. ’861 patent, col. 24, l. 53 - col. 25 l. 6 (emphases added). And claim 5 reads: 5. A method of dispensing reagents onto a slide, the method comprising the steps of: providing a plurality of reagent cont ainers in a reagent support, each of the reagent containers having a reagent barcode; providing at least one slide on a slide support, the slide having a bar code; providing a bar code reader; reading the bar codes on the reagent containers; determining reagents in the reagent containers based upon the reading of the bar codes on the reagent containers; reading the slide bar code on the at least one slide; determining a sequence of reagents to be applied on the at least one slide based upon the reading of the slide bar code on the slide; and dispensing the reagents in the reagent containers based upon the sequence of reagents to be applied. ’861 patent, col. 25, ll. 18-36 (emphases added). The district court construed the “dispensi ng” claim limitation to require “direct dispensing,” meaning that “the reagent is dis pensed directly from the reagent container” onto the slide, rather than utilizing an in termediate transport mechanism to transfer reagent from the reagent cont ainer to the slide. Claim Construction Order , slip op. at 5- 7. The district court held t hat the context in which the “dispensing” term is used in the claim “necessitates ‘direct dispens ing’ 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 cons truction of “dispensing” because all of

06-1074 5the disclosed embodiments dispense reagent di rectly from the bo ttom 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 par ticular 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 r eagent container and then releases or “spits” the reagent onto the slide. The ’861 patent issued from a conti nuation of a continuation of a division of a continuation of U.S. Patent Application No. 07/924,052 (t he “’052 application”), which originally presented 93 claims. 1 Independent claim 1 of the ’052 application provided: 1. A biological reaction apparatus for dispensing a selected reagent directly to a sample , said biological reaction apparatus having: a reagent carousel having a plural ity of reagent container supports thereon; homing and indexing means, operatively coupled to the reagent carousel, for identifying the position of eac h reagent container support with reference to a home position; and drive means, engaging the reagent car ousel and operatively coupled to said homing and indexing means, for rotating the reagent carousel and positioning a preselected reagent c ontainer support in a reagent supply zone wherein said reagent supply zone is oriented so that a reagent in a container in said preselect ed reagent container support is dispensable directly to a sample

. (emphases added). The examiner rejected independent claim 1 and dependent claims 2-3 and 5-6 of the ’052 application under 35 U.S.C. § 103 as being unpatentable over two prior art references, Wakatake et al. and Assmann et al. In response, the inventors argued that neither the Wakata ke nor the Assmann reference disclosed the capability to dispense reagent “directly to a sample”:

1 The six patents that s hare a common disclosure with the ’861 patent are all descendants of the ’052 application.

06-1074 6[E]ven in the unlikely event t hat Wakatake and Assmann were successfully combined into one system, the resulting system would still lack the present invention’s novel c apability to dispense reagent “directly to a sample” as set forth in Applicants’ Claim 1, at line 16.

. . . . . . . [T]he recited apparatus prov ides for direct dispensing of reagent from a reagent contai ner to a sample. . . . The present invention uses the “drive means” to rotate the “reagent carousel.” The reagent carousel holds the reagent containers. As can be seen in the Figures, the Reagent carousel is positioned above the samples and the reagent containers are oriented within the ca rousel with their outlet nozzles pointing down such that they are ready to dispense reagent directly to the sample below. . . . In contrast, Wakatake et al t eaches reagent tables positioned side by side with a reaction table. (Wakatak e et al, Figure 2). This side by side configuration precludes dispensing of the reagent “directly to a sample” or the incorporation of a “reagent delivery z one” as set forth in Claim 1 of the present invention. The Wakatake side by side configuration requires an additional device, a reagent pipetting device, to transfer the reagent between tables and mediate the dispensi ng of reagent to the sample. The reagent pipetting device is used to su ck up an aliquot of reagent from a reagent container on one of at least two reagent tables, pivot so that the pipetting tube of the device is held just above a selected reaction vessel on a separate reaction table, and dis pense the aliquot of reagent to the vessel (Wakatake at column 4, line 42 to column 5, line 10). Such devices are referred to in the trade as “sip and spit” devices. The district court held that these statements during pros ecution amounted to a “clear and unmistakable” disclaimer of “sip and sp it” dispensing from claim 1 of the ’052 application. Claim Construction Order , slip op. at 11. The dist rict court further held that this disclaimer attached to claims 1 and 5 of the ’861 patent because there is a common claim limi tation to which the disclaimer is directed: “direct dispensing.” The court has already construed the claim term “dispensing” in the ’861 patent to mean “direct dispensing” and thus, the ’052 application and ’861 patent have the same claim limitation. The “sip and spit” disclaimer may properly attach to the ’861 patent (direct) dispensing limitation. Id.

06-1074 7II This court reviews claim construction de novo. Cybor Corp. v. FAS Techs., Inc. , 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc). On appeal, Ventana argues that the district court improperly limited the scope of the term “dispensing” to cover only those methods of dispensing in which the reagent c ontainer is also the reagent dispenser (i.e., “direct dispensing”). Accordingly, Ventana asks this court to reverse the district court’s claim construction and construe the phrase “dispensing” to mean “to apply reagent to the slide.” We agree that t he district court improperly im ported limitations from the specification when it construed the term “dis pensing” to require “direct dispensing.” Claim terms “‘are generally given thei r 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. Ci r. 1996)). And “the ordinary and customary meaning of a claim te rm is the meaning t hat 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 sugges t 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. To start with, claims 1 and 5 do not c ontain 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.” Though the district court held t hat the word “onto” in the language of the claim necessitated “direct dispensing” becaus e the claims require that reagent in the

06-1074 8reagent container be dispensed “ onto” the slide, BioGenex agr eed at oral argument that the word “onto” does not by itself exclude the “sip and spit” met hod of dispensing from the ordinary meaning of “dispensing.” Instead, BioGenex argues that the patent ’s specification compels a narrow construction of “dispensing.” BioGenex firs t points to the “BAC KGROUND ART” section of the patent, which discusses a number of prior art automated staining devices, including a device that BioGenex alleges employs the “sip and spit” method of dispensing. ’861 patent, col. 2, ll. 6-16. BioGenex argues that because the patent goes on to state that “[t]he previously known devices are limited in their performance and unable to satisfy the needs for automated, hi gh precision immunohistology” and that it was an object of the invention to “provide a device which provides more rapid, reliable and more reproducible results than standard methods,” id. at col. 2, ll. 26-31, the patent makes clear that the invention does not practi ce the “sip and spit” method of dispensing. We decline to interpret these general st atements by the inventors to effect a complete surrender from the cl aims of the ’861 patent of a ll types of dispensing except “direct dispensing.” For one thing, the “BACKGROUND ART” section includes discussion of a number of differ ent prior art devices that em ploy a number of different dispensing techniques, including a device that employs a “direct dispensing” technique. Id. at col. 1, l. 65 - col. 2, l. 5 (“Stark, E. et al, J.Immunol.Methods. 107:89-92 (1988) describes a microprocessor controlled system including a revolving table or carousel supporting radially positioned slides. A stepper motor rotates the table, placing each slide under one of the stati onary syringes positioned above the slides. A predetermined volume of liquid, determined by a dial, is del ivered to a slide from each syringe.”). Thus,

06-1074 9if BioGenex’s argument were correct, the in ventors have also disavowed coverage of “direct dispensing,” which is the type of di spensing employed by the patent’s preferred embodiment. For this reason, BioGenex’s argument cannot be correct. Moreover, this is not a case in which t he inventor’s distinguishing the invention over the prior art in the specification result s in a disavowal of co verage by the inventor of features in the prior art. In Phillips , we recognized that in certain cases, “the specification may reveal an intentional disclai mer, or disavowal, of claim scope by the inventor.” Phillips , 415 F.3d at 1316. In such cases, th is court interprets the claim more narrowly than it otherwise would to give effe ct 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. Ad vanced 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 inventi on is intended to improve upon prior art automated staining methods: “The prev iously known devices are limited in their performance and unable to satisfy the needs for automated, high precision immunohistology. It is an object of this inv ention to provide a device which provides more rapid, reliable and more reproducible results than standard met hods . . . .” ’861 patent, col. 2, ll. 26-31. Such general stat ements, without more, will not be interpreted to disclaim every feature of every prio r art device discussed in the “BACKGROUND ART” section of the patent. Next, BioGenex points out that all of the ’861 pat ent’s disclosed embodiments employ a “direct dispensing” method of di spensing. BioGenex s ubmits that when the specification is read in its ent irety, one of skill in the art would come to the “inescapable

06-1074 10conclusion that the novelty of Ventana’s inv ention is the birthday cake or over/under carousel arrangement for direct dispensi ng.” As a result, BioGenex argues, the specification has implicitly defined the term “dispensing” to mean “direct dispensing.” There are, however, several problems wi th this argument. “It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the in vention to which the patentee is entitled the right to exclude.’” Phillips , 415 F.3d at 1312 (quoting Innova/Pure Water, Inc. v. Sa fari Water Filtration Sys., Inc. , 381 F.3d 1111, 1115 (Fed. Cir. 2004)). “[A]lthough the specification oft en describes very spec ific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.” Id. at 1323. While the fact that the disclosed embodi ments 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 r eagent 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 ar gument is that each claim does not necessarily cover every feature disclosed in the specificati on. 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 f eatures 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 requirem ent that every claim directed to that

06-1074 11invention be limited to encompass all of them. ”). Here, the claims of the ’861 patent are directed toward automated methods of dis pensing that use bar codes to determine which reagents should be dispensed onto wh ich slides. Although the preferred embodiments also contain a “direct dispensing” feature, the invent ors were not required to claim this feature in the ’861 patent and, indeed, did not do so.
III Ventana also argues that the district court erred in hol ding that the inventors of the ’861 patent disclaimed cove rage of “sip and spit” dispensing during prosecution of the ’052 application, an ancestor of the ’861 patent. BioGenex responds that the inventors disclaimed “sip and spit” dispensing when they distinguished the prior art “sip and spit” devices because of t hose devices’ inability to dispense reagent “directly to a sample,” as required claim 1 of the ’052 application. BioGenex thus raises the doctrine of pros ecution disclaimer. “[T]he prosecution history can often inform the meaning of the claim l anguage by demonstrating how the inventor understood the inventi on and whether the inventor lim ited 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 exam ine the patent’s prosecution history, when placed in evidence, to determine whet her 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 cl aim term in the descendant patent uses different language. Invitrogen Corp. v. Clontech Labs., Inc. , 429 F.3d 1052, 1078 (Fed.

06-1074 12Cir. 2005) (“[T]he prosecution of one claim term in a parent applicati on 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 allegedl y disclaiming statements were made with respect to claim language that expressly required r eagent in the reagent container to be “dispensable directly to a sample.” Indeed, in distinguishing the prior art, the inventors stated that the prior art “s ip 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 sp it” dispensing during the prosecution of the ’052 application does not apply to t he asserted claims of the ’861 patent. 2

2 BioGenex makes a number of argum ents in response to a perceived argument by Ventana that a disclaimer made during prosecution of the ’052 application does not apply to the claims of the ’861 pat ent because the ’861 pat ent resulted from a divisional application as opposed to a cont inuation application. We do not understand Ventana to be making this argument, howev er, so we need not address BioGenex’s responses to it. Regardless of whether the ’861 patent result ed from a divisional application or a continuation application, the alleged disclaimer of “sip and spit” dispensing does not apply to the asserted clai ms of the ’861 patent because claim 1 of the ’052 application and the asserted claims of the ’861 patent do not share a common claim term in dispute.

06-1074 13Indeed, we agree with Ventana that the pr osecution history of the ’861 patent supports a broad construction of “dispensing.” For example, during the prosecution of the application that led to t he ’861 patent, the examiner iss ued a restriction requirement. With respect to the applicati on 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 t he patent examiner did not cons ider the “dispensing” claim term to be limited to the “dir ect dispensing” embodiment discl osed 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.
IV BioGenex next argues that the inventors disclaimed “sip and spit” dispensing from claims 1 and 5 of the ’861 patent dur ing the prosecution of two later-issued patents, the ’901 patent and the ’029 patent. The district court did not address the relevance, if any, of the prosecution hist ories of the ’901 and t he ’029 patents in its claim construction opinion. Nevertheless, for the reasons described below, we agree with Ventana that the prosec ution histories of these la ter patents do not inform the proper construction of “dispensing” in claims 1 and 5 of the ’861 patent. The ’861 patent issued from U.S. Pat ent Application No. 09/452,309 (the “’309 application”). Each of the later-issued patent s resulted from conti nuations of the ’309

06-1074 14application. 3 Independent claim 72 of the ’169 applicat ion (which issued as claim 1 of the ’901 patent) provided, in part: 72. A biological reaction apparatus fo r dispensing a selected reagent to a slide containing a sample, said biol ogical reaction apparatus comprising: a reagent carousel having a plural ity of reagent container supports thereon; a homing and indexing device, oper atively coupled to the reagent carousel, for identifying the position of each reagent container support with reference to a home position; [and] a motor engaging the reagent ca rousel and operatively coupled to said homing and indexing device, for rotating the reagent carousel and positioning a preselected reagent c ontainer support in a reagent supply zone, wherein said reagent supply zone is oriented so that reagent in a container in said preselected reagent container support is dispensable to a slide and wherein each of the reagent container supports is arranged to accommodate a reagent container such that it is positioned above a slide when in the reagent supply zone whereby the reagent is dispensable from a lower end of said container onto the slide

. . . . (emphases added). In responding to a obviousness reject ion of application claim 72 and its corresponding dependent claims, the inventors di stinguished a prior art “sip and spit” reference because it transferred reagents “by pipettes into cuvettes 106 held in sample analysis carousels 102 that ar e adjacent to and not below the reagent carousel” as required by the claims. In di stinguishing another prior art re ference, the inventors stated that the invention of claim 72 et al. includes a sample carousel arranged beneath a reagent carousel [and] the reagent is dispensed onto a slides [sic] position below the reagent carousel. . . . Locating the carousel including samp les containing slides below the reagent carousel is an important feat ure of the claim ed invention because it allows the reagent to be applied directly to the samples on the slides.

3 The ’901 patent issued from U.S. Patent Application No. 10/137,169 (the “’169 application”), which was a continuation of a continuation of the ’309 application. The ’029 patent issued from U.S. Pat ent Application No. 10/054,535 (the “’535 application”), which was a conti nuation of the ’309 application.

06-1074 15BioGenex asserts that these statements am ount to a disclaimer of “sip and spit dispensing” that should be applied to the claims of the ’861 patent. We have held that statements made by t he inventor during continued prosecution of a related patent applicati on can, in some circumstances, be relevant to claim construction. See Microsoft Corp. v. Multi-Tech Sys., Inc. , 357 F.3d 1340, 1349 (Fed. Cir. 2004) (recognizing that “t he prosecution history of one patent is relevant to an understanding of the scope of a common term in a second patent stemming from the same parent application”). As with st atements made by the inventor during the prosecution of an ancestor application, statements made during the continued prosecution of a sibling application may “inform the meaning of the claim language by demonstrating how the inventor understood the invention.” Phillips , 415 F.3d at 1317. But here, once again, BioGenex points to statements made with respect to claim language that expressly required the reagent to be “dispensable from a lower end of [the] container onto the slide.” Because cl aims 1 and 5 of the ’861 patent do not contain this claim language, these statements are not relevant to the construction of “dispensing” in claims 1 and 5 the ’861 patent. Similarly unpersuasive is BioGenex’s assert ion that the inventors disclaimed “sip and spit” dispensing during prosecution of the ’029 patent. Independent claim 92 of the ’535 application (which issued as claim 17 of the ’029 patent) called for “a method of dispensing reagents onto a slide” where the reagent container and t he slide support are moved “relative to one another to position t he reagent container over the slide.” In response to an obviousness rejection, the in ventors distinguished a prior art “sip and spit” device because it positioned the reagent containers adjacent to the receptacles

06-1074 16into which the reagents were dispensed. Thus , the prior art device did not position the reagent container “over the sli de,” as required by the claim. Claims 1 and 5 of the ’861 patent, however, do not contain this language. Consequently, the statements pointed to by BioGenex are not relevant to the constr uction of “dispensing” in claims 1 and 5 the ’861 patent. 4
CONCLUSION Because the district court erred in its construction of “dispensing,” we vacate the judgment of noninfringement and rem and for further proceedings. COSTS Each party shall bear its own costs. VACATED AND REMANDED

4 BioGenex also points out that the patent examiner issued an obviousnesstype double patenting rejection of all of the claims of the ’ 535 application over the claims of the ’861 patent. The inventors res ponded to the obviousness-type double patenting rejection by filing a terminal disclaimer. BioGenex argues that the filing of the terminal disclaimer represents an admission by the in ventors “equating all claims of the ’535 application to all claims of the ’861 Patent.” As a result of the terminal disclaimer, BioGenex argues, any prosecution disclaimer of “sip and spit” dispensing in the ’535 application applies to the claims of the ’861 patent. We disagree. For one thing, “the filing of a terminal disclaime r simply serves the statutory function of removing the rejection of double patenting, and raises neit her presumption nor estoppel on the merits of the rejection.” Quad Envtl. Techs. Corp. v. Union Sanitary Dist. , 946 F.2d 870, 874 (Fed. Cir. 1991). Moreover, the inventors’ filing of a terminal disclaimer does not change the fact that the asserted claims of the ’861 patent do not c ontain the “over the slide” limitation present in claim 92 of the ’535 application. As a result, arguments made during prosecution of the ’535 application with respect to whether the prior art “sip and spit” devices positioned the reagent container “over the slide” are irrelevant to the construction of “dispensing” in claims 1 and 5 of the ’861 patent.

06-1074 17

## United States Court of Appeals for the Federal Circuit

06-1074

VENTANA MEDICAL SYSTEMS, INC., Plaintiff-Appellant,

v.

BIOGENEX LABORATORIES, INC., Defendant-Appellee.

LOURIE, Circuit Judge , dissenting. I respectfully dissent from the majori ty’s decision to vacate and remand based upon its construction of the term “dispensing.” I believe that the district court correctly construed the disputed term in light of the specification and, for that reason, I would affirm. “[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, in cluding the spec ification.” Phillips v. AWH Corp. , 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). The s pecification “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 “dispensi ng” clearly means “direct dispensing.”The ’861 patent is part of a f a mily of s i x other patents sharing a common specification, although only c l aim 15 of the ’707 patent expressly recites “direct dispens ing. ” 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 dispens ing directly. Nonetheles s , the claims must be construed in light of the specification, which is the same for all seven pat ents and which repeatedl y describes dis pensing reagent directly from a reagent container onto a sl ide. The Summary of the Invention describ es “positioning a preselected reagent container support and associat ed reagent c ontainer in a reagent supply zone. The apparatus has a reagent deliv er y actuator means pos it ioned for engaging a reagent container positioned on a container support in the reagent supply zone and initiating reagent delivery from the reage nt container to a slide supported on a slide support in the reagent receiving zone.” ’861 patent, col. 2, ll. 53-59. The Sum m ary further describes using a “volumetric pump means , and a reagent delivery actuator means positioned for activating the volumetric pump means, thereby effecting delivery of reagent from a reagent containe r by the vol u metric pump to the reagent delivery zone.” ’861 patent , col. 3, ll. 53-56. Those statements of delivery from a reagent container to a slide describe direct dispensing. They descr ibe the ess ence of the invention and clearly show that the reagent is dis pensed directly from a reagent container pos itioned in a support onto a slide. Such statements are repeated throughout the rest of t he specification. For example, in the Detailed Descr iption of the Invention, the specification describes that

2“[t]he carousel 10 is rotated by the stepper mo tor 14 drive belt 16 to a position plac ing a selected reagent bottle 12 in the reagent deliv ery position under the air cylinder reagent deliv ery actuator 18 over a slide to be treated with reagent.” ’861 patent, col. 6, ll. 54- 57. The s pecification further indicates t hat the “reagent deliv ery actuator 18, supported by support arm 216, contacts reagent bottle 218, directly over slide 214.” ’861 patent, col. 9, ll. 24-26 (emphasis added). The text accompanying Figure 15 des cribes the dispens ing: “Delivery of pressurized ai r to the cylinder 18 causes rod 304 and its attached foot 306 to move downward against a reagent container 12 positioned in the reagent delivery zone. Downward movement of reagent container 12 causes emission of a precis e volume of reagent liquid 310.” ’861 patent, co l. 11, ll. 40-45. Finally , Figures 1, 2, 3, 4, 11, 15 depict the apparatus that empl oys dir e ct dispensing. T he figures depict reagent containers in a carous el placed directly over a slide to dispens e the reagent from the container onto the slide. Statements describing dispens ing reagent directly from a reagent container ont o a slide ar e thus found in the abstract, the summary of the invention, the detailed disclos ure of the invention, and t he figures. Those stat em ents do not merely describe a preferred embodiment of the inv e ntion; they broadly dis c lose the overall invention of all seven pat ents. The majority points ou t that, because the pr eferred embodiment disclos es direct dispensing, we should not li mit the claims to only that which is the disclos ed embodiment. However, this is not a ca se of limiting the claims by looking at a preferred embodiment. Direct dispens ing is the essence of the invention, and the specification supports that c onclusion. The specific ation, shared by all s e v en patents, leads to the “inescapable conc lusion” that t he invention of the ’861 patent consists of

3“direct dispensing.” Microsoft Corp. v. Mult- T ech Sys., Inc. , 357 F.3d 1340, 1348 (Fed. Cir. 2004) (citing SciMed Life Sys., Inc

. v. Ad vanced Cardiovascular Sys., Inc. , 242 F.3d 1337, 1342 (Fed. Cir. 2001)). M o reover, nowhere does the specification s uggest that the invention includes the alternative “s ip and spit” dispensing method, involving dispens ing reagent from an upright container by means of a pipette. Accordingly, I believe that the dis t rict court correctly construed the claims to require “direct dispens ing. ” An examination of the prosecution hist ory confirms that Ventana viewed its inventions as limited to direct dispensing. In a related grandparent application, in order to overcome an examiner’s rejection, V entana argued that the prior ar t lacked the “present invention’s novel capability to dispen se reagent ‘directly t o a sample’” and that the “apparatus of the present inv ention” uses a reagent ca rousel and reagent container supports, “which minimize the time requi red to apply a given reagent, and the time between the application of mult iple reagents, by dispens ing reagent ‘directly to a sample.’” Ventana further stated: “As can be seen in the Figures, the reagent carousel is positioned above t he 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.” Thos e statements made in t he prosecution of the related patent applic ation, having the same specification, reflect that Ventana understood its own inv ention to be limited to direct dispensing. We cannot construe the claims to c o ver subject matter broader t han that which the pat entee desc r ibed in its specification, regarded as comp rising its invention, and represented to the Patent and Trademark Office.

4Even though those statements from the prosecution were made in a grandpar ent patent application, they relate to the comm on spec ification and reflect Ventana’s own understanding of its invent ion. I believe, therefore, that the statement in the prosecution of the ’052 application is indic a tiv e of the proper interpretati on of the same claim term in the later-issued ’861 patent. In sum, the district court appropriately considered the specification and related prosecution history and determi ned the ordinary meaning of “d is pensing” in light of all the intrinsic evidenc e. I see no error in the court’s approach or result. Accordingly, I would affirm the distri ct court’s cl aim construction.

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