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AFFYMETRIX, INC. v. HYSEQ

January 22, 2001

AFFYMETRIX, INC., PLAINTIFF AND COUNTERDEFENDANT,
v.
HYSEQ, INC., DEFENDANT AND COUNTERPLAINTIFF. AFFYMETRIX, INC., PLAINTIFF AND COUNTERDEFENDANT, V. SYNTENI, INC. AND INCYTE PHARMACEUTICALS, INC., DEFENDANTS AND COUNTERPLAINTIFFS.



The opinion of the court was delivered by: Fogel, U.S. District Judge.

ORDER*fn1 CONSTRUING CLAIMS OF U.S. PATENTS NOS. 5,445,934, 5,744,305, 5,800,992, AND 5,795,716

I. INTRODUCTION

Both of the cases captioned above are patent infringement suits. Affymetrix, plaintiff in both cases, asserts four separate patents against the named defendants. The cases were consolidated for the purpose, inter alia, of construing disputed patent claim terms. On November 29 and 30, 2000, the Court conducted a tutorial and hearing to assist it in construing the claims of United States Patents Nos. 5,445,934 (the '934 patent), 5,744,305 (the '305 patent), 5,800,992 (the '992 patent), and 5,795,716 (the '716 patent). After considering the arguments and evidence presented by all parties, the Court will construe the principal disputed terms as set forth below. Certain of the disputed terms have not been construed. If necessary, the parties may request the Court to construe the remaining terms at a later date. The Court will request supplemental briefing as to the term "substantially complementary."

II BACKGROUND

Affymetrix's four patents relate to "DNA chip" or "array" technology. Two of the patents, the '934 and the '305 patents, claim "arrays" or "substrates," wherein a high density of different nucleic acids (RNA or DNA) is placed on a solid support, such that users may perform experiments on a large number of different nucleic acids at one time, in a single reaction. The '992 patent claims methods of detecting nucleic acid sequences in the arrays by using labeled complementary nucleic acids that hybridize to nucleic acid sequences in the arrays. The fourth patent, the '716 patent, concerns computer programs which translate the raw data from the experiments into genetic information about the sample.

In the two cases captioned above, Affymetrix asserts that Defendants Incyte Pharmaceuticals, Inc. and Synteni (collectively, "Incyte") infringe the '934, '305, and '992 patents; and that Defendant Hyseq, Inc. ("Hyseq") infringes the '305, '992, and '716 patents. A brief discussion of each of the patents in suit follows.

A. The '934 Patent, Entitled "Array of Oligonucleotides on a Solid Support."

The '934 patent claims a "substrate," which has a surface comprising at least 1,000 groups of oligonucleotides with different, known sequences covalently attached to the surface in discrete known regions. The 1,000 or more groups of oligonucleotides occupy a total area of less than one square centimeter. The '934 patent was filed on September 30, 1992 and issued on August 29, 1995.

Affymetrix accuses Incyte of infringing claims 1, 5, 6, and 7 of the '934 patent. Claims 1 and 7 are independent claims.

B. The '305 Patent, Entitled "Arrays of Materials Attached To A Substrate"

The '305 patent, like the '934 patent, claims a chip apparatus. In this case, the claims recite an "array of oligonucleotides" or an "array of polynucleotides." The apparatus is comprised of a solid support and oligonucleotides or polynucleotides attached to the solid support at a density of greater than 400 different oligonucleotides or polynucleotides per square centimeter. The oligonucleotides or polynucleotides are attached to the surface of the solid support in different predefined regions, and the different oligonucleotides have different determinable sequences. The '305 patent was filed on June 6, 1995 and issued on April 28, 1998.

Affymetrix accuses Hyseq of infringing claims 1, 2, 5, 8, 15, 17, and 20 of the '305 patent, and accuses Incyte of infringing claims 1, 3-13, and 15-25. Claims 1 and 15 are the only independent claims.

C. The '992 Patent, Entitled "Method of Detecting Nucleic Acids."

The '992 patent claims a method for detecting nucleic acid sequences that may be used in connection with an array of polynucleotides, where the polynucleotides are comprised of a determinable nucleic acid. The method utilizes the well-known ability of nucleic acid sequences to "hybridize" to complementary sequences.

The '992 patent claims a method of simultaneously detecting the presence of two sets of specific nucleic acid sequences, where one collection of nucleic acids is labeled with one label, and another collection of nucleic acids is labeled with a different label, distinguishable from the first. The two collections of labeled nucleic acids are substantially complementary to a nucleic acid of the array. The collections of labeled nucleic acids are made to contact the arrays so as to detect hybridization of the labeled nucleic acids to complementary nucleic acids in the arrays.

The '992 patent further claims a method of detecting differential expression of each of a plurality of genes in one cell type compared to expression of the same genes in a second cell type. This method involves adding a mixture of labeled nucleic acid from the two cell types to an array of polynucleotides representing genes derived from the two cell types. The labels are distinct fluorescent labels, which are examined under fluorescence excitation conditions. The method is practiced under conditions that allow hybridization to complementary sequence polynucleotides in the array. The '992 patent was filed on June 25, 1996 and issued on September 1, 1998.

Affymetrix accuses Hyseq of infringing claims 1 and 3 of the '992 patent, and Incyte of infringing claims 1, 3, 4, and 5. Claims 1 and 4 are independent claims.

Although the specifications of the '934, '305, and '992 patents differ in many respects, the patents are related in that all three derive from the originally filed U.S. Patent Application No. 362,901 (the '901 Application). Each of the patents is based on separate continuation-in-part applications that are based, either directly or indirectly, on the '901 Application.*fn2

D. '716 Patent, Entitled "Computer-Aided Visualization and Analysis System for Sequence Evaluation"

Affymetrix accuses Hyseq of infringing claims 3, 4, 7, 8, 9, and 10. Claims 3, 4, 7, and 8 are independent claims.

III LEGAL STANDARD

Claim construction is purely a matter of law, to be decided exclusively by the Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 387, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Claims are construed from the perspective of a person of ordinary skill in the art at the time of the invention. Markman v. Westview Instruments, Inc., 52 F.3d 967, 986 (Fed.Cir. 1995). To determine the meaning of the claim terms, the Court initially must look to intrinsic evidence, that is, the claims, the specification, and, if in evidence, the prosecution history. Autogiro v. United States, 181 Ct.Cl. 55, 384 F.2d 391 (1967). The Court must look first to the words of the claims themselves. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996). These words are to be given their ordinary and customary meaning unless it is clear from the specification and prosecution history that the inventor used the term with a different meaning. Id. The claims should be interpreted consistently with the specification. See Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed.Cir. 1998). Arguments and amendments made during prosecution of a patent application limit claim terms so as to exclude any interpretation that was disclaimed during prosecution. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed.Cir. 1995).

Where intrinsic evidence alone resolves any ambiguity in a disputed claim term, it is improper to rely on extrinsic evidence. Vitronics, 90 F.3d at 1583, 1585. However, extrinsic evidence may be considered in the rare instances where the intrinsic evidence is insufficient to enable the court to construe disputed claim terms. Id. at 1585.

IV DISCUSSION

As a preliminary matter, the Court addresses a threshold argument that Incyte repeatedly offers concerning claim construction.*fn3 Incyte relies on the canon of claim construction which states that, "[w]hen claims are amenable to more than one construction, they should when reasonably possible be interpreted so as to preserve their validity." Modine Mfg. v. U.S. Int'l Trade Comm'n, 75 F.3d 1545, 1557 (Fed.Cir. 1996). Arguing that the '934, '305, and '992 specifications do not enable Affymetrix's claim constructions under 35 U.S.C. § 112, ¶ 1, Incyte urges rejection of Affymetrix's proffered constructions.

Specifically, Incyte asserts that Affymetrix's true invention is the "Very Large Scale Immobilized Polymer Synthesis" or "VLSIPS" technology. This technology originally involved the use of light sensitive compounds in the stepwise formation, monomer-by-monomer, of polypeptides, not polynucleotides, such that the synthesis occurs on the solid support, or chip apparatus. Incyte argues that even if, arguendo, the specifications of the '934, '305, and '992 patents enable chips with polynucleotides, those chips are only enabled for polynucleotides synthesized monomer-by-monomer directly on the solid support. Accordingly, Incyte imposes the limitation requiring monomer-by-monomer synthesis on multiple disputed terms in the claims.

Although the Court acknowledges that it must attempt to interpret claims in a manner which will sustain their validity, courts do not have authority to redraft claims for this purpose. Process Control Corp. v. Hydreclaim Corp., 190 F.3d 1350, 1356-57 (Fed.Cir. 1999) (refusing to adopt a construction that would avoid invalidity where there was only one reasonable interpretation of the claim term). Moreover, while the Court may use the specification to interpret words in the claim, it is improper to import extraneous limitations from the specification into the claim terms. E.I du Pont de Nemours & Co. v. Phillips Petro., 849 F.2d 1430, 1433 (Fed.Cir. 1988) (refusing to read limitations into a claim to avoid invalidity due to prior art). The du Pont court declined "extraneous limitation" as any limitation read into a claim from the specification wholly apart from any need to interpret what the patentee meant by particular words or phrases in the claim. Id.

In light of these various doctrines of claim construction, the Court rejects Incyte's arguments to the extent that they purport to limit the claims to only what Incyte asserts is enabled by the specification. Incyte has provided no authority to support its effort to transform claim construction analysis into a full non-enablement and written description analysis. While Incyte cites several cases which demonstrate the Federal Circuit's strict application of the enablement requirement to biotechnology inventions — see Enzo Biochem v. Calgene, 188 F.3d 1362 (Fed. Cir. 1999); Regents of the Univ. of California v. Eli Lilly, 119 F.3d 1559 (Fed.Cir. 1997); Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200 (Fed.Cir. 1991) — none of these cases dictate that the enablement analysis must be incorporated into claim construction.

None of the other cases relied upon by Incyte require limiting the meaning of claim terms solely on the basis of an invalidity analysis. Contrary to Incyte's interpretation, the Federal Circuit in Schering Corp. v. Amgen Inc., 222 F.3d 1347 (Fed. Cir. 2000), limited the meaning of the term "Interferon alpha" because the patentee had explicitly limited that definition during prosecution. Id. at 1352-53. The Federal Circuit expressly disagreed with the district court's rationale that the term should be limited because a broader interpretation would render the claim invalid for improper introduction of new matter. Id. at 1352-54. Instead, the court based its claim construction on the established doctrine requiring a court to adopt a patentee's explicit definition of a term. Id. Likewise, in Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328 (Fed.Cir. 2000), the court construed "water-soluble polydextrose" to be restricted to that prepared with a citric acid catalyst, because the specification explicitly had limited the term to polydextrose produced using a citric acid catalyst.*fn4 Id. at 1331.

Collectively, this Court interprets the cases cited above to instruct that the asserted non-enablement of a proffered claim construction alone is not a proper basis for rejecting that construction. Instead, the Court must conduct the traditional claim construction analysis, looking first to the claim language itself, then to the specification and prosecution history. If the Court concludes from this analysis that a claim term is susceptible to two or more meanings, the Court then must, where possible, adopt a meaning which renders the claim valid. Adopting this approach, the Court now proceeds to construe the disputed terms.

A. '934 Patent

Claim I of the '934 patent reads:

A substrate with a surface comprising or more groups of oligonucleotides with different, known sequences covalently attached to the surface in discrete known regions, said 103 or more groups of oligonucleotides occupying a total area of less than 1 cm2 on said substrate, said groups of oligonucleotides having different nucleotide sequences.

Claim 7 of the '934 patent reads:

An array of more than 1,000 different groups of oligonucleotide molecules with known sequences covalently coupled to a surface of a substrate, said groups of oligonucleotide molecules each in discrete known regions and differing from other groups of oligonucleotide molecules in monomer sequence, each of said discrete known regions being an area of less than about 0.01 cm2 and each discrete known region comprising oligonucleotides of known sequence, said different groups occupying a total area of less than 1 cm2

1. oligonucleotides is construed to mean polymers of nucleotides ranging in length from 2 to about 100 nucleotides.

Affymetrix contends that "oligonucleotides" means polymers, or small polymeric stretches, of nucleotides, ranging in length from 2 to about 100 nucleotides.

Incyte contends that "oligonucleotides" means single-stranded polymers of nucleotides synthesized monomer by monomer and less than about 20 nucleotides in length.*fn5

The Court looks to the plain meaning of the term, which suggests small polymers of nucleotides. At the time of the hearing, the parties agreed that oligonucleotides range from 2 to 100 nucleotides in length. The Court rejects Affymetrix's assertion that the term also encompasses small polymeric stretches, given that such a definition would effectively expand "oligonucleotides" to include polynucleotides of unlimited length. A patentee may be his own lexicographer, provided the definition is clearly set forth in the specification. Beachcombers v. WildeWood Creative Prods., Inc., 31 F.3d 1154, 1158 (Fed.Cir. 1994). However, Affymetrix fails to cite any intrinsic evidence to support its unconventional interpretation.

The Court rejects Incyte's argument that the term, "oligonucleotides," must be limited to single stranded synthetic nucleotides made monomer by monomer. Incyte has failed to cite any portion of the specification or prosecution history indicating that patentee intended the specific term, "oligonucleotide," to be limited in this manner.*fn6 Instead, Incyte relies exclusively on the argument that, without this limitation, the claim would be invalid for non-enablement. The Court rejects this argument for the reasons discussed above. Further, the Court finds that in this case, "oligonucleotide" is not reasonably amenable to a definition restricting it to single stranded synthetic nucleotides made monomer by monomer. In such a case, the Court cannot rewrite the claims, even if necessary to avoid a finding of invalidity. Process Control, 190 F.3d at 1357.

2. known sequences is construed to mean sequences of monomers identified prior to attachment to the surface.

Affymetrix contends that "known sequences" means sequences of identified or identifiable monomers.

Incyte contends that "known sequences" means a polymer synthesized monomer by monomer, and whose sequence is determined by the monomer by monomer synthesis process used to generate it.

The Court adopts the plain and ordinary meaning of the words, "known sequences," as there are no statements in the specification or prosecution history which indicate that the inventors intended the words to have a meaning inconsistent with the ordinary meaning. Accordingly, the Court finds that Affymetrix's assertion that unknown but identifiable sequences are encompassed by the ordinary meaning of "known sequences" is untenable, as this definition contradicts the ordinary meaning of "known."

Furthermore, for the reasons previously discussed, the Court finds that "known sequences" cannot be restricted only to those sequences which Incyte asserts are enabled by the specifications. "Known sequences" is not reasonably amenable to a definition restricting it to polymers synthesized monomer by monomer, whose sequence is determined by a monomer by monomer synthesis process, and the Court will not import this extraneous limitation into the claim.

3. covalently attached is construed to mean directly secured or joined to the solid surface such that every chemical bond between the oligonucleotide and the surface is a covalent bond. Affymetrix contends that "covalently attached" means secured to the solid surface through a covalent bond, either directly or indirectly. Affymetrix's definition requires that only the bond at the point of attachment to the surface, whether to the oligonucleotide or to the linker, be a covalent bond. (Markman hearing transcript at 413:9-415:26).

Incyte contends that "covalently attached" means the oligonucleotide is covalently bonded to the surface by the 3' end of the oligonucleotide. Incyte's definition requires that, if a linker molecule is used to covalently attach the oligonucleotide to the surface, every bond between the surface and the oligonucleotide must be a covalent bond. (Id. at 416:14-18).

The Court adopts the plain and ordinary meaning of the words, "covalently attached" to determine that the oligonucleotide is secured or joined to the solid surface by covalent bonding. The Court rejects Affymetrix's suggestion that the oligonucleotide may be "indirectly" covalently attached to the surface via a noncovalent bond between the oligonucleotide and a linker molecule, as long as a covalent bond exists between the linker and the surface. Such an interpretation contradicts the plain language of the claim, which requires covalent attachment between the oligonucleotide and the surface, not merely between a linker and the surface. Affymetrix has failed to point to any intrinsic evidence to suggest that it intended "covalent attachment" to have any meaning other than this conventional meaning.

4. discrete known regions are construed to mean identified localized areas on a surface which are, were, or are intended to be activated for formation of a polymer, where the activation is accomplished through exposure of the localized area to an energy source adapted to render a group active for synthesis of the polymer on the surface or for immobilization of a pre-existing polymer on a surface.

Incyte contends that a "discrete known region" is a localized area on a surface which is, was, or is intended to be activated for synthesis of a polymer, and which is also spatially addressable for activation of monomer by monomer synthesis.

Both parties accept the definition of "regions" that the patentee explicitly offers in the specification. In defining "predefined ...


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