The opinion of the court was delivered by: Hon. Roger T. Benitez United States District Judge
This matter comes before the Court for claim construction. The parties have filed opening and responsive claim construction briefs and the Court held a claim construction hearing. The parties, Gen-Probe, Inc. ("Gen-Probe") and Becton Dickinson and Company ("BD") seek construction of fifteen terms with regard to the Automation Patents and eight terms with regard to the Cap Patents.*fn1 Having considered the parties briefing and oral argument, the Court construes the terms as follows.
The five Automation Patents*fn3 at issue in this action result from the development of a single automated instrument to detect a target nucleic acid indicative of the presence of a target pathogen within a sample. The two Penetrable Cap Patents,*fn4 also at issue in this case, describe a specimen collection vessel that allows the contents of the vessel to be sampled by an automated device.
Gen-Probe's automated instrument, TIGRIS® Instrument System, was launched in 2003 for the detection of two viruses and later approved for use in the detection of additional viruses. In this action, Gen-Probe accuses BD of infringing claims of the Automation Patents through the use and sale of the VIPER XTR and BD Max, BD's automated nucleic acid test instruments.
The Automation Patents describe an automated method of nucleic acid-based testing, a method for detecting the presence of a particular pathogen in a sample. Nucleic acid-based testing involves the creation of a complementary nucleotide sequence that a target pathogen will bind to through complementary base pairing. The complementary nucleotide sequence is used as a probe. The probe is introduced to a sample that may contain the target nucleic acid. If the target binds to the probe, it indicates the target nucleic acid is present in the sample.
As explained in the Automation Patents, the performance of this process manually has disadvantages, including human error, carryover contamination, and cross contamination. The Automation Patents automate the steps of this process in a single instrument. Receptacles are moved using transport mechanisms between locations of a processing deck where various steps of the assay are performed. The Cap Patents use a seal or seals on a collection vessel that are penetrated by a fluid transfer device. The seal or seals, in conjunction with the core structure, are intended to prevent the release of aerosols from the sample and limit contamination from fluid on the fluid transfer device after removal.
"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 v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted). Courts determine the meaning of disputed claim terms from the perspective of a person of ordinary skill in the art at the time the patent is filed. Chamberlain Group, Inc. v. Lear Corp., 516 F.3d 1331, 1335 (Fed. Cir. 2008). "[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, 415 F.3d at 1313. "Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court looks to 'those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean.'" Phillips, 415 F.3d at 1314 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)). Those sources include 'the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art." Id. (citing Innova, 381 F.3d at 1116).
Claim terms "are generally given their ordinary and customary meaning." Phillips, 415 F.3d at 1312 (internal quotation marks omitted). When construing claim terms, the court should first look to sources in the intrinsic record. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). First, "the claims themselves provide substantial guidance as to the meaning of particular claim terms." Phillips, 415 F.3d at 1314. Second, the claims "must be read in view of the specification, of which they are a part." Id. at 1315 (internal quotation marks omitted). The specification is usually "dispositive," as "it is the single best guide to the meaning of a disputed term." Id. (internal quotation marks omitted). Third, the court should consider the patent's prosecution history, which is the record of proceedings before the Patent and Trademark Office ("PTO") and includes the prior art cited during the patent examination. Id. at 1317. However, "because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id.
If the intrinsic evidence resolves the ambiguity in the disputed claim terms, then "it is improper to rely on extrinsic evidence." Vitronics, 90 F.3d at 1583. If ambiguities in the claim terms remain, however, courts may consider extrinsic evidence. Id. at 1584. Extrinsic evidence includes expert testimony, inventor testimony, dictionaries, and scientific treatises. Phillips, 415 F.3d at 1317.
The Court notes that the disputed claim terms appear across the five Automation Patents at issue in this case and in numerous claims. However, the parties agree that the disputed terms have common meanings across the different patents and claims. Because the claim terms appear across numerous patents and in multiple claims, the Court incorporates the parties' joint claim construction chart that identifies the specific intrinsic evidence in each of the implicated patents that is relevant to the disputed term rather than reciting each instance of support. The Court's references to particular language in one patent is not intended to be to the exclusion of other intrinsic evidence in additional patents.
Because the disputed claim terms appear across numerous claims and patents, the parties provided exemplary claims in which the disputed terms appear. The Court includes those exemplary claims for each disputed claim term before discussion of each, but does not exclusively rely on the patents from which the exemplary claims are drawn.
A. "process comprising the automated steps" and "process comprising performing the automated steps" and "process comprising performing . . . the . . . automated steps"
A process for detecting the presence of a target nucleic acid in a sample containing the target nucleic acid, the process comprising the automated steps of: ('256 Patent, Claim 1.)
A process for detecting the presence of a target nucleic acid in a sample containing the target nucleic acid, the process comprising performing the automated steps of: ('652 Patent, Claim 1.)
A process for preparing and amplifying a target sequence contained within a target nucleic acid present in a fluid sample, the process comprising performing in a stand-alone unit the ordered and automated steps of: ('892 Patent, Claim 1.) . Gen-Probe proposes that the "process comprising the automated steps" means "the steps of the claimed process are performed by a machine that, once set up and initialized, requires little or no operator intervention." BD proposes that "process comprising the automated steps" means that "each individual step of the claimed process is performed without human intervention, but the claim does not preclude human intervention between steps." Gen-Probe relies primarily on the specification and BD relies exclusively on the use of the word "comprising." The Court adopts Gen-Probe's construction.
BD argues that because the word "comprising" is an open-ended term, it does not foreclose the addition of elements or steps, including human intervention between steps. However, this construction specifically adds the potential for human intervention between steps, a reading completely contrary to the specification. This is problematic in two respect. First, the language BD proposes, "human intervention between steps," does not originate from the claims, specification, or prosecution history. Rather, it is simply an allowance for inclusion of the opposite of an automated process - human intervention between automated steps. Second, BD's proposed construction contradicts the specification. The specification identifies problems with manual performance of the steps of a nucleic-based assay, including practitioner error, pathogen exposure, and cross contamination. ('892 Patent 4:5-9.) The specification then goes on to explain that these problems are addressed by the invention, described as an automated clinical analyzer. ('892 Patent 4:30-39, 45-47.) BD's proposed construction is improper because it conflicts with the description of the invention in the specification. See Phillips, 415 F.3d at 1313 ("[C]laims must be construed so as to be consistent with the specification.").
Gen-Probe's proposed construction is drawn from language in the specification and is consistent with the purpose described in the specification. Gen-Probe's proposed construction - "the steps of the claimed process are performed by a machine that, once set up and initialized, requires little or no operator intervention" - tracks language from the specification that provides that "once the analyzer . . . is set-up and initialized, it ordinarily requires little or no operator assistance or intervention." ('892 Patent 60:61-61.) Additionally, the portion of the proposed construction that indicates that the process is "performed by a machine" is consistent with the specification language discussed above that describes the invention as an "automated clinical analyzer." ('892 Patent 4:45-47.) Finally, Gen-Probe's proposed construction does not conflict with the use of the word "comprising" in the claim. While "comprising" is an open-ended term allowing for the addition of other elements, Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 502 (Fed. Cir. 2007), Gen-Probe's proposed construction is not closed because it allows for manual set- up and limited operator intervention as described in the specification. See CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1235 (Fed. Cir. 2005) (affirming construction that allowed for manual set up of an automatic process with a claim that used the word "comprising"). Because Gen-Probe's proposed construction is drawn from and consistent with the specification, the Court adopts Gen-Probe's proposed construction. See Phillips, 415 F.3d at 1315 ("[T]he specification is always relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.").
B. "stand alone unit" and "self-contained analyzer"
The process of claim 1, wherein steps a)-f) are performed within a stand-alone unit. ('256 Patent, Claim 9.)
(d) detecting the amplification product of step (c) as an indication of the presence of the target nucleic acid in the sample, wherein the steps of the process are performed in a self-contained analyzer. ('652 Patent, Claim 1.)
Gen-Probe proposes that "stand alone unit" and "self-contained analyzer" mean "a single unit/analyzer in which all the steps are performed within a shared, open environment." BD proposes that "stand alone unit" and "self-contained analyzer" mean "a single system that integrates and coordinates the operation of various automated stations for performing the steps of a diagnostic assay."*fn5 Gen-Probe relies on a overall vision of the invention drawn from the specification and file history distinguishing prior art. BD relies on the description of the invention in the summary of the invention section of the specification. The Court adopts the following construction "a single system that integrates and coordinates the operation of various automated stations or modules for performing the steps of a diagnostic assay."
Gen-Probe argues that "stand-alone unit" and "self-contained analyzer" must possess everything within it necessary to perform the assay because the specification describes the automated clinical analyzer as "preferably a self-contained, stand alone unit" with "[a]ssay specimen materials and reaction receptacles, as well as the various solutions, reagents, and other materials used in performing the assay . . . preferably stored within the analyzer." ('892 Patent 4:52-58.) But, Gen-Probe goes on to argue that "stand-alone unit" and self-contained analyzer" must also be "a shared, open environment." This language, or even a description similar to "shared, open environment," does not appear anywhere in the specification or file history. Rather, Gen-Probe relies on claims that explain various steps occurring at particular stations or target nucleic acids being transferred from one station to another within something. Gen-Probe suggests these steps must necessarily occur "within a shared, open environment." Additionally, Gen-Probe relies on the file histories, emphasizing that prior art prescribed physical separation of the steps. While the Court agrees that "stand-alone unit" and "self-contained analyzer" describe something that preferably contains all the steps of the assay within itself, there is little support for the vague and ambiguous "shared, open environment" language chosen by Gen-Probe.*fn6
BD's proposed construction tracks language in the summary of the invention section of the specification that describes the analyzer. The specification states that the "analyzer integrates and coordinates the operation of various automated stations, or modules, involved in performing one or more assays [and the] analyzer is preferably a self-contained, stand alone unit." ('892 Patent 4:48-52.) BD's proposed construction is more closely aligned with the description of the invention in the specification, although the construction BD offers does not justify using only "automated stations" to the exclusion of "modules." Accordingly, the Court adopts the following construction: "a single system that integrates and coordinates the operation of various automated stations or modules for performing the steps of a diagnostic assay."
C. "the target nucleic acid immobilized in step a)" and "the separated target nucleic acid"
c) transferring the target nucleic acid immobilized in step a) from the first station to a second station using a rotatable transport mechanism ('256 Patent, Claim 1.)
(d) moving a solution comprising the separated target nucleic acid to a second station of the analyzer; (d) in an incubator of the second station, subjecting the separated target nucleic acid to an amplification procedure and forming an amplification product ('255 Patent, Claim 1.)
Gen-Probe proposes that "the target nucleic acid immobilized in step a)" means "at least one target nucleic acid immobilized in step a)" and "the separated target nucleic acid" means "at least one target nucleic acid immobilized in step c)." BD proposes that "the target nucleic acid immobilized in step a)" means "all (or substantially all) of the target nucleic acid immobilized during step a)" and "the separated target nucleic acid" means "all of the separated target nucleic acid that was separated in step c)." Because Gen-Probe's construction follows from the plain language of the claim and BD's construction draws primarily from extrinsic evidence, the Court adopts Gen-Probe's construction. See Phillips, 415 F.3d at 1316 ("The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.").
The parties essentially dispute whether "the" means "at least one" or "all (substantially all)." BD argues that a person of ordinary skill in the art would read "the" to mean an entire group of nucleic acid molecules and encompass all or substantially all of the target nucleic acid. Specifically, with regard to "the separated target nucleic acid," BD argues "the" includes the entirety of the immobilized target nucleic acid present. BD's proposed construction is based on particularizing "the" to a population of target nucleic acids. The Court agrees that "'the' particularizes the subject which it precedes." NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1306 (Fed. Cir. 2005) (quoting Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1356 ...