Invitrogen Corp. v. Biocrest Mfg., L.P.

• Decision Date: 07 May 2003
• Docket Number: No. 02-1260.,No. 02-1207.,02-1207.,02-1260.
• Citation: 327 F.3d 1364
• Parties: INVITROGEN CORPORATION, Plaintiff-Appellant, v. BIOCREST MANUFACTURING, L.P., Stratagene Holding Corporation and Stratagene, Inc., Defendants-Cross Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

327 F.3d 1364

INVITROGEN CORPORATION, Plaintiff-Appellant, v. BIOCREST MANUFACTURING, L.P., Stratagene Holding Corporation and Stratagene, Inc., Defendants-Cross Appellants.

No. 02-1207.

No. 02-1260.

United States Court of Appeals, Federal Circuit.

Decided May 7, 2003.

Francis M. Wilkstrom, Parsons Behle & Latimer, of Salt Lake City, Utah, argued for plaintiff-appellant. With him on the brief were C. Kevin Speirs and Kristine Edde Johnson. Of counsel on the brief was Alan W. Hammond, Invitrogen Corporation, of Carlsbad, California.

Marc R. Labgold, Ph.D., Patton Boggs LLP, of McLean, Virginia, argued for defendants-cross appellants. With him on the brief were Kevin M. Bell and Laura A. Donnelly. Of counsel on the brief was Richard J. Oparil, Patton Boggs LLP, of Washington, DC.

Before RADER, BRYSON, and DYK, Circuit Judges.

RADER, Circuit Judge.

On summary judgment, the United States District Court for the Western District of Texas determined that Biocrest Manufacturing, L.P., Stratagene Holding Corporation, and Stratagene, Inc. (collectively Stratagene) did not infringe Invitrogen Corporation's (Invitrogen's) U.S. Patent No. 4,981,797 (issued Jan. 1, 1991) (the '797 patent). Invitrogen Corp. v. Biocrest Mfg., L.P., No. A 01 CA 167 SS (W.D.Tex. Nov. 2, 2001). Because the district court incorrectly construed the claims of the '797 patent, this court vacates and remands.

I.

The '797 patent involves DNA technology. DNA molecules have nucleotide sequences called genes that act as blueprints for proteins. Modern medicine may supplement the production of important proteins in the body to treat various maladies. These treatment regimes require large quantities of a particular gene or its corresponding protein. To produce proteins, a laboratory may introduce a DNA molecule containing a particular gene into the bacterium E. coli, which serves as a factory to replicate many copies of the DNA molecule and its gene. When an E. coli cell replicates by cell division, the DNA in that E. coli cell also replicates, providing an increased number of gene sequences from which protein can be expressed. Thus, the E. coli can serve as a factory to produce important proteins.

The '797 patent claims a process for making E. coli cells with an enhanced capacity to accept foreign DNA. A cell that accepts foreign DNA is called a transformable cell. The transformable cell's capacity to accept foreign DNA is called its competence. The '797 patent thus claims a method of producing transformable E. coli cells with improved competence. The foreign DNA is generally plasmid DNA — a relatively small DNA molecule having a looped circular shape. Claim 1 of the '797 patent states:

1. A process for producing transformable E. coli cells of improved competence by a process comprising the following steps in order:

(a) growing E. coli cells in a growth-conducive medium at a temperature of 18° C. to 32° C.;

(b) rendering said E. coli cells competent; and

(c) freezing the cells.

'797 patent, col. 10, ll. 26-32 (emphases added).

Invitrogen accused Stratagene of infringing claims 1-5, 7-11, and 13-16 of the '797 patent. Stratagene makes and sells competent E. coli cell lines. Stratagene makes its cell lines by a process that includes the steps of incubating cells at 37° C, growing the cells in a fermenter at 26° C, and freezing the cells.

On March 12, 2001, Invitrogen filed a complaint against Stratagene in the District Court for the Western District of Texas. On August 16, 2001, the district court held a Markman hearing to construe the claims. On August 30, 2001, the district court issued an order construing the preamble term "improved competence" and the growing step (a). On September 11, 2001, Stratagene filed a motion for summary judgment of noninfringement based on the district court's claim construction. On November 2, 2001, the district court granted Stratagene's summary judgment motion. On January 31, 2002, the district court issued a final judgment dismissing the action.

Invitrogen appealed the district court's summary judgment of noninfringement. Invitrogen asserts that the district court erred in concluding that the growing step (a) excludes all cell growth carried out above 32° C. Invitrogen also disputes that the preamble term "improved competence" limits the claims. Stratagene cross-appealed. Stratagene asserts that the district court erred in concluding that the preamble term "improved competence" means that competence is "generally increased" with no numerical limitation.

This court has jurisdiction under 28 U.S.C. § 1295(a)(1) (2000).

II.

This court reviews without deference a district court's grant of summary judgment, and draws all reasonable factual inferences in favor of the non-movant. Cortland Line Co. v. Orvis Co., 203 F.3d 1351, 1355-56, 53 USPQ2d 1734, 1736 (Fed.Cir. 2000). This court decides for itself whether "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c).

A court determines patent infringement by first construing the claims and then applying the construed claims to the accused process or product. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976, 34 USPQ2d 1321, 1326 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). This court reviews a district court's claim construction without deference. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454, 46 USPQ2d 1169, 1174 (Fed.Cir.1998) (en banc).

Claim language generally carries the ordinary meaning of the words in their normal usage in the field of invention. Toro Co. v. White Consol. Indus., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir.1999). While this "ordinary meaning" rule is usually expressed as a pat formula, the context supplied by the field of invention, the prior art, and the understanding of skilled artisans generally is key to discerning the normal usage of words in any claim. See, e.g., Hoechst Celanese Corp. v. BP Chems., Ltd., 78 F.3d 1575, 1579 (Fed. Cir.1996).

The applicant may also act as his own lexicographer and use the specification to implicitly or explicitly supply new meanings for terms. Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268, 59 USPQ2d 1865, 1870-71 (Fed.Cir.2001). While prosecution history estoppel does not apply to determining literal claim scope, statements to an examiner during prosecution before the United States Patent and Trademark Office (PTO) may also illuminate the scope of the claims. See Ballard Med. Prods. v. Allegiance Healthcare Corp., 268 F.3d 1352, 1358, 60 USPQ2d 1493, 1498 (Fed.Cir.2001). Moreover, an applicant may actually disclaim claim scope during prosecution. Id. at 1361. The applicant, however, must clearly and unambiguously express any such surrender of subject matter during prosecution. See Middleton, Inc. v. Minn. Mining & Mfg. Co., 311 F.3d 1384, 1388, 65 USPQ2d 1138, 1141 (Fed.Cir.2002); Inverness Med. Switz. GmbH v. Princeton Biomeditech Corp., 309 F.3d 1365, 1372, 64 USPQ2d 1926, 1932 (Fed.Cir.2002).

A. The "Growing" Step

The district court construed the growing step (a) to mean that "growth must be performed at a temperature within 18° C to 32° C, inclusive, and that at no time prior to freezing can the temperature of the cells exceed 32° C." Invitrogen Corp v. Biocrest Mfg., L.P., No. A 01 CA 167 SS, slip op. at 10 (W.D.Tex. Aug. 30, 2001) (Claim Construction Order). The district court rejected Invitrogen's argument that the term "comprising" in the preamble meant that claim 1 was open-ended and thus allowed an additional step of growing cells at 37° C before the growing step (a). The district court instead read the prosecution history of the '797 patent to disclaim all growth outside the range in step (a). In other words, the district court's claim interpretation foreclosed any growth other than growth in the claimed temperature range.

When entering a rejection during prosecution of the application that led to the '797 patent, the PTO examiner stated that 18° C to 32° C was essential to the invention. The applicants then amended the claims to replace "less than 37° C" with "18° C to 32° C" in claim 1. The applicants then stated that their amendment ensures that the claimed invention is different from prior art showing growth at 37° C. Furthermore, the applicants noted that the invention avoids undesirable effects of growth at 37° C. On the basis of this rather sketchy record, the district court concluded that the applicants had disclaimed all growth outside the range of 18° C to 32° C. Therefore the district court interpreted the claim to exclude any growth outside that range.

To the contrary, claim 1 does not address and therefore permits growth before the steps disclosed in the claim at temperatures outside the range of 18° C to 32° C. At the outset, the claim language itself does not preclude growth in advance of the first step in the claim. Step (a) of claim 1 specifies E. coli population growth at 18° C to 32° C. Step (b) specifies rendering competent the cells that immediately result from step (a). Step (b) conveys this by stating "rendering said E. coli cells competent" (emphasis added). The cells that are rendered competent in step (b) include specific cells formed at 18° C to 32° C in step (a). At no point has this claim addressed or limited any activities that may have occurred before steps (a) and (b).

The transition "comprising" in a method claim indicates that the claim is open-ended and allows for additional steps. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 811, 53 USPQ2d 1289, 1301 (Fed.Cir.1999) (citing Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1271, 229 USPQ 805, 812 (Fed.Cir.1986)). Claim 1 uses the open-ended transition "comp...