Abaxis, Inc. v. Cepheid

• Decision Date: 22 July 2011
• Docket Number: Case No.: 10-CV-02840-LHK
• Parties: ABAXIS, INC., Plaintiff, v. CEPHEID, Defendant.
• Court: U.S. District Court — Northern District of California

ABAXIS, INC., Plaintiff,

v.CEPHEID, Defendant.

Case No.: 10-CV-02840-LHK

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION

Dated: July 22, 2011

ORDER CONSTRUING DISPUTED CLAIM TERMS

Plaintiff Abaxis, Inc. filed suit against Defendant Cepheid, alleging infringement of four patents. The parties now seek construction of four disputed terms used in the claims of the patents. The Court held a tutorial on June 15, 2011, and a claim construction hearing on June 21, 2011. The Court has reviewed the claims, specifications, and other relevant evidence, and considered the briefing and arguments of the parties. The Court now construes the terms at issue.

I. Background

Plaintiff Abaxis, Inc. develops technology for use in diagnostic medical testing. Such testing frequently involves mixing a biological sample with a chemical reagent and monitoring the chemical reaction that follows. In order to achieve consistent, accurate testing that can be performed efficiently and inexpensively, the reagents used must be provided in precise amounts, with minimal variation, and they must dissolve rapidly. To address this need, Abaxis developed a method for producing freeze-dried reagent beads or spheres that contain precisely measuredamounts of chemical reagents. These reagent beads or spheres are typically formed by preparing an aqueous solution of the reagent, dispensing uniform, precisely measured drops of the solution into a cryogenic liquid, and lyophilizing the frozen drops to form dried beads or spheres.

Various aspects of these bead/sphere compositions and the methods for their preparation are claimed in patents owned by Abaxis, including the following patents-in-suit: Patent Number 5,413,732 (the "'732 patent"), Patent Number 5,624,597 (the "'597 patent"), Patent Number 5,776,563 (the "'563 patent"), and Patent Number 6,251,684 (the "'684 patent"). Each of these patents derives from a patent application filed on August 19, 1991, which issued as the '732 patent. The '597 patent issued from a continuation application from the '732 patent and shares the same specification with the '732 patent. The '563 and '684 patents are child patents of an abandoned continuation-in-part application. They share overlapping subject matter with the specification of the '732 and '597 patents, but are not identical. The first claim of the '732 patent provides an illustration of the types of inventions claimed in the four patents:

1. A method for forming a plurality of uniform, precisely measured reagent spheres, the method consisting essentially of the steps of:

forming a homogeneous solution of a reagent;

precisely measuring uniform drops of the solution;

dispensing the uniform, precisely measured drops into an unagitated cryogenic liquid, whereby the drops are frozen;

collecting the frozen drops from the cryogenic liquid; and

lyophilizing the frozen drops, thereby forming a plurality of reagent spheres having a coefficient of weight variation less than about 3% and which completely dissolve in an aqueous solution in less than about 10 seconds.

In its First Amended Complaint, Abaxis claims that a number of Cepheid products infringe the four patents-in-suit. Abaxis contends that when it first approached Cepheid regarding its alleged infringement, Cepheid entered into a royalty-bearing license agreement for use of Abaxis's patented inventions and paid fees under that agreement for over four years. Opening Br. at 4, ECF No. 54. Abaxis claims that in late 2009, Cepheid refused to make further payments under the licensing agreement, but has continued to sell infringing products. Id. Accordingly, Abaxis's complaint asserts four claims of patent infringement, as well as a claim for breach of the license agreement. Cepheid denies these allegations and asserts counterclaims for declarations of non-infringement, invalidity, and unenforceability of Abaxis's patents, a declaration as to the term of the '597 patent, and for breach of contract. The Court granted Abaxis's motion to dismiss Cepheid's inequitable conduct defense and counterclaim on March 22, 2011, and a motion to dismiss the amended inequitable conduct defense and counterclaim is pending.

The case is currently before the Court for construction of the following four disputed claim terms:

(1) "dissolves in less than about 10 seconds in water/an aqueous solution";

(2) "about";

(3) "A container holding a dried chemical composition . . . wherein said dried chemical composition comprises a preselected precisely measured aliquot of said dried chemical composition"; and,

(4) "bead."

II. Legal Standard

Claim construction is a question of law to be determined by the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996). "Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelop with the claim." Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed.Cir. 2005) (quoting Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed.Cir. 1998)). Accordingly, a claim should be construed in a manner that "stays true to the claim language and most naturally aligns with the patent's description of the invention." Id.

In construing disputed terms, the court looks first to the claims themselves. "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.'" Id. at 1312 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). Generally, the words of a claim should be given their "ordinary and customary meaning," which is "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention." Id. at 1312-13. In some instances, the ordinary meaning to a person of skill in the art is clear, andclaims construction may involve "little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314. In many cases, however, the meaning of a term to a person skilled in the art will not be readily apparent, and the court must look to other sources to determine the meaning of the term. Id.

The meaning of a term may be illuminated by the context in which it is used in an asserted claim, or by usage of the term in related claims. Id. Importantly, however, "the 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." Id. at 1313. Accordingly, claims "must be read in view of the specification, of which they are a part." Id. at 1315 (quoting Markman, 52 F.3d at 979). Indeed, the specification is "always highly relevant" and "the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). At the same time, the Federal Circuit has cautioned against limiting claims to the specific embodiments of the invention. Phillips, 415 F.3d at 1323. A court "should also consider the patent's prosecution history, if it is in evidence." Id. (quoting Markman, 52 F.3d at 980).

In addition to such intrinsic evidence, a court may rely on extrinsic evidence, such as dictionaries and treatises, to shed light on the claimed technology. Phillips, 415 F.3d at 1317. However, such evidence is considered "less significant than the intrinsic record" and "less reliable than the patent and its prosecution history in determining how to read claim terms." Id. at 1317-18 (quotation marks and citation omitted). Ultimately, while extrinsic evidence may be useful in claim construction, "it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1319.

III. Discussion

A. "dissolves in less than about 10 seconds in water/an aqueous solution" ('563 patent, claim 1; '684 patent, claim 6)

+-----------------------------------------------------------------------------+
                ¦Abaxis's Proposed Construction  ¦Cepheid's Proposed Construction             ¦
                +--------------------------------+--------------------------------------------¦
                ¦                                ¦"completely dissolves in less than about 10 ¦
                ¦No construction necessary.      ¦                                            ¦
                ¦                                ¦seconds in water/an aqueous solution"       ¦
                ¦(i.e., "dissolves" means        ¦                                            ¦
                ¦dissolves)                      ¦(i.e., "dissolves" means                    ¦
                ¦                                ¦completely   dissolves)                     ¦
                +-----------------------------------------------------------------------------+
                

The first claim term in dispute is the phrase "dissolves in less than about 10 seconds in water/an aqueous solution." This term appears in the '563 and '684 patents, as follows:

'563 Patent, claim 1:

A container holding a dried chemical composition which dissolves in less than about 10 seconds in water, wherein said dried chemical composition comprises a pre-selected precisely measured aliquot of said dried chemical composition which chemical composition is in bead form have in [sic] a diameter between 1.5 mm and 10.0 mm. (emphasis added)

'684 Patent, claim 6 (dependent on claim 1):

1. A dried chemical reagent composition comprising a plurality of dried beads having a coefficient of weight variation of less than about 3%, and a diameter of between about 1.5 mm and about 10 mm or the equivalents thereof.

6. The composition of claim wherein the beads dissolve in less than about 10 seconds in an aqueous solution. (emphasis added)

Although the parties identify the entire phrase as the disputed term, their briefing is focused solely on the...