Free Brief in Opposition to Motion - District Court of Colorado - Colorado

Case 1:03-cv-01973-PSF-MJW

Document 153-4

Filed 09/26/2005

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EXHIBIT C

EXHIBIT C

Case 1:03-cv-01973-PSF-MJW

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2001 WL 34082554 (S.D.Cal.) (Cite as: 2001 WL 34082554 (S.D.Cal.))

claim construction order. Only the Westlaw citation is currently available. United States District Court, S.D. California. ABBOTT LABORATORIES, an Illinois corporation, Plaintiff, v. SYNTRON BIORESEARCH, INC., a California corporation, Defendant. No. 98-CV-2359 H(POR). March 7, 2001. Order Denying Abbott's Motion to Strike; Order Granting in Part, Denying in Part, Syntron's Motion for Reconsideration, Clarification, and Application of the Court's Claim Construction Order; Setting Date for Pre-Trial Conference HUFF, Chief J. *1 AND RELATED CROSS-ACTIONS. On February 2, 2001, Syntron filed a Motion for Reconsideration, Clarification, and Application of the Court's January 5, 2001 Claim Construction Order, Syntron seeks reconsideration based on an intervening change in controlling law, [FN1] clear error, and manifest injustice. Syntron raises five primary arguments in its motion. First, Syntron asserts that its devices do not infringe because the reactant on the test line is not "specific for" the analyte of interest, as that term was construed by the Court. Second, Syntron argues that there is a question of fact as to whether the reactant on Syntron's test line is "non-diffusively bound." Third, Syntron argues that its liquid-permeable solid media do not contain a "well." Fourth, Syntron contends that the terms "flowing ... through" and "having traversed" are disputed and have not been construed by the Court. Finally, Syntron argues that the terms "number of zones" and "analyte in a predetermined amount" still need to be construed by the Court. FN1. By intervening change in controlling law, Syntron is referring to the Court's January 5, 2001 Discussion A. Abbott's Motion to Strike Abbott argues that Syntron's motion for reconsideration is too late under the Court's scheduling order and local rules. Abbott states that Syntron is not seeking reconsideration of the Court's claim construction but rather reconsideration of the Court's infringement order, which was handed down on June 28, 2000 and amended on August 2, 2000. Given that Syntron had an opportunity to raise infringement issues during its cross-motion for summary judgment of non-infringement and its first motion for reconsideration, Abbott urges the Court to strike this motion for reconsideration. In addition, Abbott contends that Syntron's motion for reconsideration is improper because it is not based on newly discovered evidence, an intervening change in controlling law, or a need to correct clear error or manifest injustice. Syntron states that it does not seek to challenge the Court's construction but to confirm that in light of that construction, the issues of infringement to which the four terms pertain are open for trial. In addition, Syntron asks the Court to construe four additional terms. Syntron argues that the motion is proper based on an intervening change in the law and the grounds of clear error or manifest injustice. Syntron contends that its motion is timely because it could not have brought it any sooner, since the terms were only recently construed. *2 A motion for reconsideration is "appropriate if the district court (1) is presented with newly discovered In response to Syntron's motion, Abbott filed an Expedited Motion to Strike on February 6, 2001. On February 9, 2001, the Court denied Abbott's request to have its motion to strike heard in an expedited fashion. On February 16, 2001, Abbott filed an Opposition to Syntron's motion. On February 20, 2001, Syntron filed an Opposition to Abbott's motion to strike. On February 26, 2001, Syntron filed its Reply in support of its motion for reconsideration. After careful consideration, the Court will decide both motions without oral argument pursuant to Local Rule 7.1(d.1).

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Case 1:03-cv-01973-PSF-MJW

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2001 WL 34082554 (S.D.Cal.) (Cite as: 2001 WL 34082554 (S.D.Cal.))

evidence, (2) committed clear error or the initial decision was manifestly unjust, or (3) if there is an intervening change in controlling law." See School Dist. No. 1J, Multnomah County v. ACandS, Inc., 5 F.3d 1255, 1263 (9th Cir.1993). "[A] motion for reconsideration should not be granted, absent highly unusual circumstances." See 389 Orange Street Partners v. Arnold, 179 F.3d 656, 665 (9th Cir.1999). A motion for reconsideration may not be used to raise arguments or present evidence for the first time when they could reasonably have been raised earlier in the litigation. See Id.; Kona Enterprises, Inc. v. Estate of Bishop, 229 F.3d 877, 883 (9th Cir.2000). Syntron has failed to demonstrate an intervening change in the law or clear error to warrant reconsideration of the Court's January 5, 2001, claim construction order. To the extent that Syntron is challenging the Court's infringement order of June 28, 2000, as amended August 2, 2000, it is too late. Nevertheless, in the interest of moving this case to trial, the Court will address Syntron's arguments. Therefore, the Court denies Abbott's motion to strike. B. Syntron's Motion for Reconsideration Syntron does not seek reconsideration of the Court's January 5, 2001 claim construction order. Rather, Syntron argues that the recent claim construction affects the Court's previous rulings on infringement and validity. Syntron asks the Court to engage in infringement analysis based on the construction of the terms "specific for," "non-diffusively bound" and "well." In addition, Syntron requests that the Court construe four more terms before trial. Analysis of patent infringement involves two steps: (1) claim construction to determine the scope of the claims, followed by (2) determination of whether the properly construed claims encompass the accused structure. Carroll Touch, Inc. v. Electro Mechanical Sys., Inc., 15 F.3d 1573, 1576 (Fed.Cir.1993). The first is a question to be determined by the court. See Markman v. Westview Instruments, Inc., 52 F.3d ed 967, 976 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370 (1996). The second is a question of fact, generally submitted to a jury. See Strattec Security Corp. v. General Automotive Specialty Co., Inc., 126 F.3d 1411, 1416 (Fed.Cir.1997) (citing Hilton Davis Chem. Co.

v. Warner-Jenkinson Co., 62 F.3d 1512, 1520 (Fed.Cir.1995) (in banc), reversed and remanded on other grounds, 520 U.S. 17 (1997)). Upon construction of the claims, summary judgment may follow when it is shown that the infringement issue can be reasonably decided only in favor of the movant, when all reasonable factual inferences are drawn in favor of the non-movant and no genuine issues of material fact exist. See Voice Technologies Group, Inc. v. VMC Systems, Inc., 154 F.3d 605, 612 (Fed.Cir.1999); Karlin Technology Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 974 (Fed.Cir.1999). *3 On June 28, 2000, the Court determined that there were no issues of material fact remaining in the infringement analysis of Claim 22 of the '162 patent. Based on Syntron's admissions, deposition testimony of Dr. Lee and Mr. Trinh, and the package inserts on Syntron's products, the Court granted summary judgment in favor of Abbott. On reconsideration, the Court ruled that there was a question of fact on infringement as to "liquid permeable solid medium." In the instant motion for reconsideration, the only term which appears in Claim 22 of the '162 patent is "specific for." The Court will address this term as it relates to the previous finding of infringement. Syntron also requests clarification or reconsideration of the Court's findings of infringement as to the claims that contain the terms "non-diffusively bound" and "well." The Court has not found infringement as to the claims that contain these terms. [FN2] In the January 5, 2001, claim construction order the Court denied Abbott's motion for summary adjudication of infringement of claims other than Claim 22. The Court has construed "non-diffusively bound" and "well" as required under Markman. In general, the determination of infringement is a question of fact for the jury. See Strattec Security Corp. v. General Automotive Specialty Co ., Inc., 126 F.3d 1411, 1416 (Fed.Cir.1997). Consequently, the Court will leave the determination of whether the properly construed claims encompass the accused device to the jury. FN2. The terms "non-diffusively bound" and "non-diffusively immobilized" appear in claims

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2001 WL 34082554 (S.D.Cal.) (Cite as: 2001 WL 34082554 (S.D.Cal.))

1(c) of the '162 Patent and 22(a) of the '484 Patent. The term "well" appears in Claims 14, 15, 26, and 27 of the '162 Patent. 1. "Specific for" In the January 5 Order, the Court construed the term "specific for" as used in the '162 patent to mean "particular to and capable of binding with" the analyte or chemical moiety of interest. The Court went on to say, "construction of the term 'specific for' does not change the Court's previous determination that Abbott is entitled to summary judgment of infringement of Claim 22 of the '162 Patent ... Specifically, the Court determined that the labeled antibodies which Syntron uses are specific for the analyte (hCG) based on the deposition testimony of Lee and Trinh and the QuikPac II insert." Syntron contends that the reactant it uses is not "particular to" hCG. Syntron asserts that its reactant, the 1001 antibody, can also bind with luteinizing hormone (LH), thyroid stimulating hormone (TSH) and follicle stimulating hormone (FSH). [FN3] Syntron has submitted new declarations from Lee and Trinh which state that now that they know the Court's construction of "specific for," they change their answers to the question of whether the capture antibody they use is specific for the analyte (hCG). Syntron contends that, if nothing else, there is a question of fact as to whether its reactant is "specific for" hCG. FN3. Syntron also argues that there has been no determination by the Court that the capture antibody (1001 antibody) that it uses in its ovulation test kits is "specific for" LH. The Court's previous orders have only focused on Syntron's pregnancy test kits. To the extent that Syntron's ovulation kits are different from its pregnancy test kits, the Court has not ruled on issues of infringement. In its Opposition, Abbott argues that Syntron's introduction of new declarations are not new evidence upon which to base a motion for reconsideration. Abbott argues that a newly submitted declaration contradicting prior deposition testimony in order to create an issue of fact only raises a

"sham" issue and does not avoid summary judgment. Abbott emphasizes Lee and Trinh's previous deposition testimony and argues that if they did not understand the term "specific for" they could have asked for clarification. Abbott also points out that Dr. David did not raise this issue in either of his expert reports last spring before summary judgment. Abbott concludes that Syntron has not raised a proper basis for reconsideration. *4 Abbott also argues that Syntron's test kits do use a test line antibody that is "particular to" hCG because it was developed to recognize and bind with hCG. Abbott's expert witness, Dr. Harlow, testified in deposition that antibodies can have some degree of cross-reactivity and still be specific for the analyte. In addition, Abbott points to the inserts on the QuikStrip and QuikPak test kits which state that the tests use both "conventional and monoclonal antibodies to specifically identify hCG in the urine." By construing the term "specific for," the Court did not intend to open up a wholesale reevalation of the Court's previous finding of infringement. Syntron should have raised the above arguments in its first motion for reconsideration. Nevertheless, the Court has thoroughly evaluated the arguments set forth by the parties, and concludes that Syntron has raised an issue of material fact as to whether the 1001 antibody is "specific for" hCG. Consequently, the Court grants Syntron's motion for reconsideration as it relates to this term. 2. Terms still to be construed Syntron requests that Court construe four more phrases in order for it to prepare its trial defenses to infringement. The four phrases are: (1) "flowing ... through" (claims 22(b) and 26 of the '484 patent); (2) "having traversed said medium" (claim 1(b) of the '162 patent); (3) "number of zone" from the sentence "wherein the number of zones in which detection occurs is related to the presence of analyte in the solution" (claim 22(c) of the '484 patent);

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Case 1:03-cv-01973-PSF-MJW

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Filed 09/26/2005

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2001 WL 34082554 (S.D.Cal.) (Cite as: 2001 WL 34082554 (S.D.Cal.))

(4) "analyte in predetermined amount" (from the sentence "wherein detection occurs in the reaction zone only if analyte is present in the test solution in a predetermined amount" (claim 26 of the '484 patent). The Federal Circuit in Markman created an obligation on the district court to instruct the jury on the meaning of the words used by an inventor in a claim. However, the Markman court did not specify the timing of claim construction. See Elf Atochem North America, Inc. v. Libbey-Owens-Ford Co., Inc., 894 F.Supp 844, 850 (D.Del.1995) (stating that district courts have three options for claim construction: (1) resolve claim disputes on the paper record; (2) hold a hearing or trial to resolve the disputes; or (3) wait until trial and resolve claim disputes the evening before the jury must be instructed). The Court has given considerable time to claim construction in this case. The parties are on notice of the Court's general claim construction of the patents. The Court declines to do another piecemeal claim construction at this stage in the proceedings. Ultimately, the Court will instruct the jury on claim construction. If claim construction disputes remain, the Court will resolve them at trial. Therefore, the Court denies Syntron's request for further claim construction at this stage in the proceedings. Conclusion For the reasons set forth above, the Court issues the following Order: *5 (1) the Court DENIES Abbott's Motion to Strike Syntron's Motion for Reconsideration, Clarification, and Application of the Court's Claim Construction Order; (2) the Court GRANTS in Part, DENIES in Part, Syntron's Motion for Reconsideration, Clarification and Application of the Court's Claim Construction Order. Specifically, the Court concludes there is a triable issue of fact on infringement of the term "specific for" as found in Claim 22 of the '162 patent. In addition, determination of infringement of the claims that contain the phrases "well" and "non-diffusively bound" will be left to the jury. Finally, the Court declines, at this time, to do claim construction on the four additional terms requested by Syntron;

(3) the Court continues the Pre-Trial Conference to Monday, May 7, 2001, at 10:30 a.m. in Courtroom 1. At the Pre-Trial Conference the Court will set the date for filing motions in limine. IT IS SO ORDERED. Not Reported in F.Supp.2d, 2001 WL 34082554 (S.D.Cal.) END OF DOCUMENT

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