Opinion
Case No. 98-CV-2359 H (POR)
January 10, 2002
Abbott Laboratories ("Abbott") initiated this suit against Syntron Bioresearch, Inc. ("Syntron") in December 1998. Abbott alleged infringement of two patents to which it holds the exclusive license, and Syntron counterclaimed for invalidity and unenforceability of those patents.
On September 11, 2001, the Court empaneled the jury. The parties then presented their evidence from September 12, 2Q01 to October 1, 2001. On October 4, 2001, the jury returned its special verdict. Pursuant to the jury's special verdict, the Court entered a final judgment on October 12, 2001,
On October 22, 2001, Syntron filed its motion for judgment as a matter of law. On October 26, 2001, Abbott filed its motion for judgment as a matter of law or, in the alternative, for a new trial. On November 13, 2001, the parties filed their respective oppositions. On November 19, 2001, Abbott and Syntron submitted their reply papers. On January 7, 2002, Syntron submitted a request for judicial notice in support of its renewed motion.
After reviewing the parties' papers, the Court held a hearing on the post-trial motions on January 9, 2002. At that hearing, See Carl Bromberg, Erik Belt, and Robert Gerber appeared on behalf of Abbott. David Doyle, Steven Comer, and Peng Chen appeared on behalf of Syntron. Having considered the controlling law, the evidence presented at trial, and the parties' arguments, the Court denies Abbott's and Syntron's post-trial motions.
FACTUAL BACKGROUND
I. The Parties
Abbott manufactures, researches, markets and sells healthcare products including diagnostic instruments, tests and reagents. Abbott's products also include rapid, self-performing immunoassays which are used for determining the presence of chemical substances in human body fluids. (See August 2, 2000 Amended Order (1) Denying Syntron's motion for summary judgment under 35 U.S.C. § 102; (2) Denying Syntron's motion for summary judgment under 35 U.S.C. § 112; (3) Denying Syntron's motion for summary judgment for non-infringement; and (4) Granting Abbott's motion for summary judgment for infringement ("Aug. 2, 2000 Order"), at 2).
Syntron is a California corporation with its principal place of business in Carlsbad, California. Syntron also produces and sells rapid self-test diagnostic products. (Id.).
II. The '162 and '484 Patents
On December 17, 1991, the United States Patent and Trademark Office (the "PTO") issued Patent No. 5,073,484 (the "'484 patent") entitled "Qualitative Analysis Apparatus and Method." (Id.). On August 5, 1997, the PTO issued Patent No. 5,654,162 (the "'162 patent") entitled "Chemical Analysis Apparatus and Method." (Id.). Those two patents list Patrick Guire and Melvin Swanson as sole inventors. (Id.). Drs. Guire and Swanson assigned their patent rights to Bio-Metric Systems Inc., now known as SunModics, Inc. (Id.). Pursuant to an licensing agreement, Abbott acquired the worldwide exclusive license to the two patents. (Id.).
For the sake of clarity and convenience, the Court may refer to the '162 and '484 patents collectively as "the Abbott patents" or "Abbott's patents."
In this suit, Abbott contends that Syntron infringed those two patents by manufacturing, marketing and selling various pregnancy and ovulation test products. (Id.). Abbott specifically identified, among others, the following products:
(1) Quick Pac II OneStep Pregnancy Test (used for early detection of pregnancy);
(2) OvuPac OneStep LH Ovulation Test (used to predict ovulation time);
(3) Quick Pac II OneStep hCG Test (used for early detection and diagnosis of pregnancy);
(4) One Step BeSure Pregnancy Test (used for detection of pregnancy).
Abbott also alleges that other unnamed Syntron products infringe its patents. (Id.).
III. The Technology Involved
Abbott's two patents relate to a technology known as "immunochemistry" or "immunoassay" technology. (Id., at 3). The patents disclose "assay" methods and devices that permits the detection or measurement of small amounts of chemical substances (known as analytes) in bodily fluids such as blood or urine. (Id.). Such tests can help to diagnose a particular condition. (Id.). For example, the presence of the pregnancy hormone known as "hCG" in a woman's urine indicates that she is pregnant. (Id.).
Immunochemistry works by utilizing certain characteristics of the immune response system. (Id.). Specifically, immunochemistry involves the use of antibodies that protect the body from infectious organisms and other toxic substances. (Id.). When infectious organisms invade the body, the immune response system's white blood cells, called lymphocytes, secrete antibodies to attack the invading molecules. (Id.). An antibody is a protein adapted to bind specifically to a particular molecule at a specific site called an epitope. (Id.). The foreign molecule to which the antibody attaches is known as an antigen. (Id.). By attaching to the foreign molecule, the antibodies neutralize the foreign antigen and facilitate the body's healing process. (See id.).
Iminunoassays utilize the binding properties of these antibodies to detect or measure an analyte. (Id.). Over the years, scientists have developed techniques to manufacture antibodies specific to certain molecules. (Id.). Using antibodies' specificity to certain molecules, scientists can detect whether a particular analyte is present in the fluid being tested. (Id.).
There are three main types of immunoassay methods: the antibody capture assay, antigen capture assay, and a two-antibody sandwich assay. (Id.). In the antibody capture assay, the antigen is attached to a solid support and an antibody is allowed to bind to it. (Id.). Scientists can then assess the presence of the bound antibody after a washing process that eliminates the unbound antibody. (Id. at 4). The antigen capture assay works in the same manner with the exception that the antibody is attached to a solid support and the antigen is measured after washing. (Id.).
A common variation of the capture assay, known as a competition assay, can be performed in an antibody or antigen format. (Id.). In the antigen capture format, a test sample with unknown amount of "unlabeled" antigen is placed in a vessel with a known sample of "labeled" antigen. (Id.). The antigen is "labeled" by adding a detectable marker to an antigen or antibody to ensure easy detection. (Id.). The vessel also contains bound antibodies. (Id.). The two antigens then compete to attach to the bound antibody and, in this competitive process, the test antigen can prevent the labeled antigen from binding. (Id.). As a result, if more test antigens remain in the vessel, less labeled antigen will stay in the vessel. (Id.). Scientists can then measure the amount of labeled antigen to determine how much remained in the vessel, thereby indicating how much antigen is present in the solution. (Id.). An antibody competition assay format functions in the same manner except that an unknown amount of antibody in a test sample competes with a known amount of labeled antibody. (Id.).
In the two-antibody sandwich assay, one of the two types of antibodies is bound to a solid medium. (Id.). The antigens in the test fluid bind to the first antibody on one epitope. (Id.). Then a labeled antibody specific to the antigen binds to the antigen on another epitope. (Id.). The antigen is analogous to a slice of meat in between two slices of bread (the two antibodies). (Id.). After washing, only the labeled antibody attached to the antigen remains on the solid medium. (Id.). The labeled antibody is then detected and, because it is attached to the antigen, the presence and concentration of the antibody can be determined. (Id.).
IV. Syntron's Accused Products
Syntron manufactures, market and sells self-performing immunoassay test-kits designed to detect human chorionic gonadotropin hormone ("hCG") in female urine. (Trial Exh. 148, Document Report for QuikPacII OneStep hCG Test for Urine Only, at S0019143). Those test-kits can be used either for laboratory or home use. (Id.; Trial Exh. 144, QuikPac II OneStep hCG Test Instructions, at S009832).
As a hormone produced by the placenta during pregnancy, hCG appears in the mother's urine shortly after fertilization and rapidly rises in concentration to reach a circulation peak in the eighth and eleventh week of pregnancy. (Trial Exh. 148, Document Report for QuickPacII OneStep hCG Test for Urine Only, at S0019143). Using that fact, Syntron designed an in vitro chromatographic immunoassay utilizing conventional and monoclonal anti-hCG antibodies to selectively identify hCG in urine. (Id.).
In the procedure to test for pregnancy, the user adds urine to a sample well by using a transfer pipette and allows the urine to migrate through the absorbent device by capillary action. (Id.). As the urine migrates through the absorbent area, it mixes with labeled antibody-dye conjugates. (Trial Exh. 144, QuikPacII OneStep hCG Test Instructions, at S009832). HCG present in the specimen binds to the conjugate forming an antibody-antigen complex. (Id.). Then, as the reaction mixture flows through a test zone, the antibody-antigen complex binds to a "capture" antibody linked to the reacting surface, creating a two-antibody sandwich assay. (See id.). Upon reaction for detection, a rose-pink color band appears. (Id.).
Although Syntron's "capture"antibody — called the "1001 antibody" — in the test area has a high affinity for hCG, it can also react with a protein called luteinizing hormone ("LH") that is also found in a woman's urine. (Tr. Vol. VIII at 3:7-3:21; Tr. Vol. VII at 155:4-157:15). Because of this potential cross-reactivity, Syntron's test-kits use a "scavenger" antibody to reduce the reactivity of LH molecules present in the sample before the sample flows through the test area. (Tr. Vol. VIII at 3:1-3:6; Tr. Vol. VII at 157:6-157:15). Hence, when the hCG molecules bound to the conjugate antibody flow through the test area, the "capture" 1001 antibody will only bind to hCG rather than LH. (Id., at 3:22-4:10).
Unbound conjugates bind to other "immobilized" reagents in a control area, giving a pink-rose control band upon reaction in that area to indicate that the test functions properly. (Trial Exh. 144, QuikPac II OneStep hCG Test Instructions, at S009832). Syntron uses the same procedure to test for ovulation by using antibodies directed against LH rather than hCG. (Trial Exh. 106, Syntron OvuPac OneStep LH Ovulation Test).
PROCEDURAL BACKGROUND
Abbott filed this case on December 30, 1998, and Syntron filed its answer and counterclaims on February 22, 1999. After discovery, the parties filed motions and cross motions for summary judgment or summary adjudication, followed by numerous requests for reconsideration and other related motions.
I. The August 2, 2000 Summary Judgment Order
On March 22, 2000, Abbott filed a motion for summary judgment against Syntron. Syntron, in turn, countered with three separate summary adjudication motions for non-infringement, and invalidity of Abbott's patents pursuant to 35 U.S.C. § 102 and 112.
On May 9, 2000, the Court heard oral argument on all four motions along with a full day Markman hearing on the construction of the claims. On May 23, 2000, the parties submitted their respective summary of their oral arguments at the Court's request. On June 29, 2000, the Court issued its rulings on all four motions. (June 29, 2000 Order Denying Syntron's Motion for Partial Summary Judgment under 35 U.S.C. § 102, Denying Syntron's Motion for Partial Summary Judgment under 35 U.S.C. § 112, Denying Syntron's Motion for Summary Judgment of Noninfringement, and Granting Abbott's Motion for Summary Judgment for Infringement). On August 2, 2000, the Court amended that order to address certain issues. (Aug. 2, 2000 Order).
II. Syntron's First Motion for Reconsideration
On August 7, 2000, Syntron moved for reconsideration and clarification of the Court's order granting Abbott's motion for summary judgment of infringement. Syntron also requested a Markman hearing, or, in the alternative, certification for appeal. After receiving opposition papers, the Court heard oral argument on the motions on September 15, 2000 and conducted an additional Markman hearing to construe the claims.
In its motion, Syntron raised four specific claim construction issues: (1) qualitative vs. quantitative; (2) "predetermined amount;" (3) "zones;" and (4) "diffusively bound labeled antibody." Syntron did not ask for reconsideration of the Court's claim interpretation of"a liquid permeable solid medium." Rather, Syntron argued that its devices do not contain "a liquid permeable solid medium" as construed by the Court.
On September 28, 2000, the Court issued its rulings on the motions for reconsideration, clarification, or certification. (Sept. 28, 2000 Order Granting in Part and Denying in Part Motion for Reconsideration and Clarification of the Court's Order Granting Abbott's Motion for Summary Judgment on Infringement; Granting in Part and Denying in Part Request for Markman Hearing; and Denying Request for Certification of Appeal). The Court granted Syntron's motion for reconsideration solely with respect to infringement, noting that the reference to the doctrine of equivalents needed some clarification. The Court declined to reconsider its other rulings issued in the August 2, 2000 Order. Upon reconsideration, the Court concluded that Syntron raised triable issues of fact on literal infringement and under the doctrine of equivalents. Moreover, the Court granted Syntron's motion to clarify its previous ruling with respect to validity. The Court thus explained that it "did not sua sponte grant a motion that was not before the court, namely a motion by Abbott for summary judgment on the question of validity." (Sept. 28, 2000 Order, at 17). The Court also denied Syntron's motion for certification.
III. Abbott's Motion for Summary Adjudication of Invalidity and Syntron's Ex Parte Motion Asserting Collateral Estoppel
On September 14, 2000, Abbott filed a motion for summary adjudication of issues of infringement and patent validity, or in the alternative, motion in limine to exclude evidence concerning and precluding relitigation of adjudicated issues at trial. Syntron filed its opposition to that motion on October 2, 2000.
On October 5, 2000, Syntron filed an Ex Parte Application claiming that Abbott is collaterally estopped from asserting claims 9-30 of the '162 patent because District Court Judge O'Toole, sitting in the District of Massachusetts, concluded that those claims were invalid. Judge O'Toole's ruling appeared in a Memorandum and Order dated September 29, 2000, in the case of Abbott Laboratories v. Selfcare, Inc. Abbott filed its reply on October 10, 2000, addressing both Syntron's opposition and the ex parte application.
After a hearing on this motion on October 16, 2000, the Court invited both parties to submit supplemental briefings due to the nature of the issues presented in the summary adjudication motion and the last-minute addition of the collateral estoppel argument. Each party submitted a supplemental brief on November 3, 2000.
On November 16, 2000, the Court issued its rulings on the pending motions. First, the Court determined that Judge O'Toole's ruling in theSelfcare case did not collaterally estop Abbott from asserting claims 9-30 of the '162 patent in this case because Judge O'Toole's ruling did not constitute a final judgment as required by Ninth Circuit law. Second. the Court denied Abbott's motion for summary adjudication that claims 9-30 of the '162 patent were not invalid based on anticipation under 35 U.S.C. § 102 or for lack of enablement under 35 U.S.C. § 112. Similarly, the Court denied Syntron's motion for summary adjudication of invalidity for lack of enablement. Finally, the Court dismissed Abbott's motion for summary adjudication of infringement on all asserted claims as premature since the Court had not yet construed many of the disputed claim terms. The Court then permitted the parties to submit additional briefs on those disputed claim terms. (Nov. 16, 2000 Order Denying Abbott's September 14, 2000 Motion for Summary Adjudication).
IV. Syntron's Motion for Reconsideration as to the Written Description Requirement
In its August 2, 2000 Order, the Court denied Syntron's motion for summary judgment of invalidity of claims 9-30 of the '162 patent for inadequate written description under 35 U.S.C. § 112. On November 6, 2000, Syntron filed a motion for reconsideration of that ruling. Syntron filed its second motion for reconsideration before the Court ruled on Abbott's motion for summary adjudication, and therefore the Court declined to address the written description requirement issue in its rulings on Abbott's motion for summary adjudication.
Syntron based its second motion for reconsideration on the recent decision by District Court Judge O'Toole in the case of Abbott Laboratories v. Selfcare, Inc., Judge O'Toole's decision invalidated claims 9-30 of the '162 patent for failing to adequately describe the "diffusively bound labeled antibody" limitation. Additionally, Syntron also asked the Court to stay the proceedings until the Selfcare court has ruled on Abbott's reconsideration motion.
On December 20, 2000, the Court issued an order denying without prejudice Syntron's second motion for reconsideration. After examining the controlling law, considering the parties' argument, and analyzing the patents-in-suit, the Court determined that genuine issues of material fact remained as to whether one skilled in the art would have considered the patentee to be in possession of the claimed invention. Moreover, the Court denied Syntron's request for a stay pending the conclusion of the proceedings in the Selfcare case. (Dec. 20, 2000 Order Denying Without Prejudice Syntron's Motion for Reconsideration and Denying Request for a Stay).
V. Abbott's Motion for Reconsideration as to the "Liquid Permeable Solid Medium" Limitation
In an order dated October 19, 2000, the Court permitted Abbott to move for reconsideration of the Court's ruling on the "liquid permeable solid medium" limitation. Abbott asserted that the Court erred in its construction of that term. In the alternative, Abbott contended that Syntron infringed the Court's construction of the limitation. Syntron disputed Abbott's arguments.
Having thoroughly reviewed the arguments by both parties and after careful consideration of the issues, the Court reaffirmed its previous ruling in an order issued on December 20, 2000. (Dec. 20, 2000 Order Denying Abbott's Motion for Reconsideration of the Court's Order Regarding "Liquid Permeable Solid Medium.").
VI. Abbott's Motion for Summary Adjudication of Infringement
In its November 16, 2000 Order, the Court dismissed Abbott's motion for summary adjudication of infringement on all asserted claims as premature. In that dismissal, the Court stated that it would address Abbott's motion for summary adjudication of infringement following its reconsideration of the term "liquid permeable solid medium" and further claim constructions. The Court thus granted the parties an opportunity to submit briefs setting forth their construction of the following limitations:
(1) "specific for" as found in claim 22 of the '162 patent, among other claims;
(2) "non-diffusively bound" as found in claim 1(c) of the '162 patent and claim 22(a) of the '484 patent;
(3) "non-diffusively immobilized" as found in claim 26 of the '484 patent;
(4) "well" as found in claims 14 and 15 of the '162 patent;
(5) "further comprising" as found in claim 28 of the '162 patent;
(6) "flowing . . . through" as found in claims 22 and 23 of the '484 patent.
In its papers, Abbott however conceded that it is not asserting claim 28 against Syntron. The parties also did not dispute the phrase "flowing . . . through." The Court therefore did not need to address the limitations "further comprising" and "flowing . . . through."
In an order dated January 5, 2001, the Court construed the remaining disputed claim terms and denied Abbott's motion for summary adjudication of infringement of all asserted claims. First, the Court construed "specific for" as "particular to and capable of binding with" the analyte or chemical moiety. Second, the Court determined that a "non-diffusively bound" reactant, as found in claim 1 of the '162 patent, means a reactant immobilized in the reaction zone so as to provide a detectable signal indicating the presence or absence of analyte in the solution. "Non-diffusively immobilized," as found in claims 22 and 26 of the '484 patent, means the same thing as "non-diffusively bound." Third, the Court gave the term "well" in claims 14 and 15 its customary and ordinary meaning as an "indentation in the surface." Thus, in claim 14, the "well" is an indentation in the liquid permeable solid medium that is the application site for the carrier liquid. Based on those claim constructions, the Court denied Abbott's motion for summary adjudication of infringement of all asserted claims. (Jan. 5, 2001 Order Construing Remaining Disputed Claim Terms and Denying Plaintiffs Motion for Summary Adjudication of Infringement).
VII. Syntron's Third Motion for Reconsideration and Abbott's Motion to Strike
On February 2, 2001, Syntron filed a motion for reconsideration, clarification, and application of the Court's January 5, 2001 claim construction order. Syntron's motion asserted that there is no infringement under the Court's January 5, 2001 claim constructions, and requested the Court's interpretation of a few additional claim terms. In response, Abbott filed an expedited motion to strike Syntron's new motion for reconsideration, but the Court denied Abbott's request to hear the motion to strike on an expedited basis. The parties then submitted their respective oppositions and replies.
On March 7, 2001, the Court ruled on Abbott's motion to strike and Syntron's third motion for reconsideration. The Court first denied Abbott's motion to strike. The Court concluded that there were triable issues of fact on infringement of the term "specific for" as found in claim 22 of the '162 patent. In addition, the Court concluded that a jury needs to determine whether Syntron infringed claims containing the phrases "well" and "non-diffusively bound." Finally, the Court declined to construe the four additional terms requested by Syntron. (Mar. 7, 2001 Order Denying Motion to Strike Motion for Reconsideration, Granting in Part and Denying in Part Motion for Reconsideration, Clarification and Application of the Court's Claim Construction Order; Setting Date for Pretrial Conference).
VIII The Trial
After convening the pretrial conference and ruling on numerous motions in limine, the Court commenced the trial in this case in September 2001. The Court conducted the voir dire and empaneled the jury on September 11, 2001. The parties then presented their evidence from September 12, 2001 to October 1, 2001. On September 25, 2001, the Court held a hearing on the parties' supplemental claim construction disputes, and issued its rulings on that same day. (Sept. 25, 2001 Order Adopting Supplemental Claim Constructions Submitted by the Parties).
In addition, the Court also made certain substantive rulings during the trial upon the parties' motion. First, upon Syntron's motion and after considering the controlling law and the record, the Court issued an order determining that prosecution history estoppel precludes any equivalent for the limitations "specific for," "non-diffusively immobilized" and "non-diffusively bound." (Oct. 3, 2001 Order Granting Syntron Bioresearch, Inc's Motion for Judgment as a Matter of Law That Prosecution History Estoppel Precludes Any Equivalent for the Limitations "Specific For," "Non-diffusively Immobilized" and "Non-diffusively Bound"). Second, the Court also denied Syntron's motion for judgment as a matter of law of non-infringement because it determined that triable issues of facts existed. (Oct. 9, 2001 Order Denying Without Prejudice Syntron Bioresearch, Inc's Motion for Judgment as a Matter of Law of Non-infringement).
After the parties presented their final arguments, the Court instructed the jury about the applicable law. After more than two days of deliberations, the jury returned its special verdict on October 4, 2001. (Special Verdict, filed Oct. 4, 2001). Pursuant to the jury's special verdict, the Court entered a final judgment on October 12, 2001 in favor of Syntron on Abbott's claims of infringement of the patents-in-suit, and in favor of Abbott as to Syntron's counterclaims of invalidity and unenforceability. (Oct. 12, 2001 Judgment).
The parties have subsequently filed the present motions for judgment as a matter of law. For the reasons provided below, the Court denies all pending motions.
LEGAL STANDARDS
I. Standards for Motions as a Matter of Law
Under Rule 50 of the Federal Rules of Civil Procedure, a court may grant a motion for judgment as a matter of law only where "there is no legally sufficient basis for a jury to find for [the non-moving] party." Fed.R.Civ.P. 5(a)(1). Thus, to prevail on a renewed motion for JMOL following a jury trial, the moving party "'must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusions implied [by] the jury's verdict cannot in law be supported by those findings.'" Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 1998) (quoting Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir.), cert. denied, 469 U.S. 857 (1984)). See also Applied Medical Resources Corp. v. U.S. Surgical Corp., 147 F.3d 1374, 1376 (Fed. Cir. 1998) (holding that the movant "must prove that the jury's factual findings were not supported by substantial evidence or that the facts were not sufficient to support the conclusions necessarily drawn by the jury on the way to its verdict.").
In order to determine whether a legally sufficient basis in fact exists, the court must consider all the evidence and draw all reasonable inferences from the evidence in the light most favorable to the non-movant. Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997); Perkin-Elmer Corp, 732 F.2d at 893 (Fed. Cir.), cert. denied, 469 U.S. 857 (1984). The court may not determine the credibility of witnesses and must not "substitute its choice for that of the jury between conflicting elements of the evidence." Perkin-Elmer, 732 F.2d at 893. If, after this analysis, substantial evidence exists to support the jury's verdict, then the motion for JMOL must be denied. See Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1269 (Fed. Cir. 1999) (citations omitted).
Consequently, the court may grant JMOL in favor of a party bearing the burden of proof only where (1) the movant "has established [its] case by evidence that the jury would not be at liberty to disbelieve;" and (2) "the only reasonable conclusion is in [the movant's] favor." Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1065 (Fed. Cir.), cert. denied, 525 U.S. 876 (1998) (citations omitted). See also Omega Envt'l, Inc. v. Gilbarco, Inc., 127 F.3d 1157, 1161 (9th Cir. 1997) (stating that "judgment as a matter of law is appropriate when the evidence, construed in the light most favorable to the nonmoving party, permits only one reasonable conclusion, which is contrary to the jury's verdict."), cert. denied, 525 U.S. 812 (1998); Baker v. Delta Air Lines, Inc., 6 F.3d 632, 644 (9th Cir. 1993) (stating that the court "'must determine whether the evidence, considered as a whole and viewed in the light most favorable to the nonmoving party, reasonably can support only a verdict for the moving party'") (quoting Gillette v. Delmore, 979 F.2d 1342, 1346 (9th Cir. 1992)).
The essential question in deciding a motion for judgment as a matter of law is whether the evidence the jury could have believed in reaching its verdict was substantial enough to support its findings. Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1573 (Fed. Cir. 1986). Thus, the question is not what the court might have believed, but what the jury could have reasonably determined. See Dawn Equip. Co. v. Kentucky Farms, Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998) ("[T]he inquiry is whether a reasonable jury, given the record before it viewed as a whole, could have arrived at the conclusion it did.").
II. Standards for Granting a New Trial
Under Federal Rule of Civil Procedure 59(a), "a new trial may be granted to all or any of the parties and on all or part of the issues in an action in which there has been a trial by jury, for any of the reasons for which new trials have heretofore been granted in actions at law in the courts of the United States." Fed.R.Civ.P. 59(a). The decision to grant or deny a new trial rests within the sound discretion of the court. Allied Chemical Corp. v. Daiflon, Inc., 449 U.S. 33, 36, (1980).
A trial court may grant a new trial if the verdict is "contrary to the clear weight of the evidence, or is based upon evidence which is false, or to prevent, in the sound discretion of the trial judge, a miscarriage of justice." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1245 (Fed. Cir.), cert. denied, 493 U.S. 853 (1989) (quoting Hanson v. Shell Oil Co., 541 F.2d 1352, 1359 (9th Cir. 1976), cert. denied, 429 U.S. 1074 (1977)). In general, a court should grant a new trial only when the judge "is left with the definite and firm conviction that a mistake has been committed." Landes Constr. Co. v. Royal Bank of Canada, 833 F.2d 1365, 1372 (9th Cir. 1987) (quoting 11 C. Wright A. Miller, Federal Practice and Procedure: Civil § 2806, at 49 (1973)). Thus, a jury verdict should ordinarily be set aside only when the verdict is against the weight of evidence or it is clear that the jury reached an erroneous result. Digidyne Corporation v. Data General Corp., 734 F.2d 1336, 1347 (9th Cir. 1984).
It is true that, in making its determination, the court "can weigh the evidence and assess the credibility of witnesses, and need not view the evidence from the perspective most favorable to the prevailing party."Air-Sea Forwarders, Inc. v. Air Asia Co., Ltd., 880 F.2d 176, 190 (9th Cir. 1989). But, "a decent respect for the collective wisdom of the jury, and for the function entrusted to it in our system, certainly suggests that in most cases the judge should accept the findings of the jury, regardless of his own doubts in the matter." Landes Constr. Co, 833 F.2d at 1371 (quoting 11 C. Wright A. Miller, Federal Practice and Procedure: Civil § 2806, at 49 (1973)). It is insufficient that the district court would simply have reached a different verdict.Richardson, 868 F.2d at 1245. With those standards in mind, the Court now turns to the motions raised by the parties.
DISCUSSION
1. Abbott's Renewed Motion for Judgment as a Matter of Law, or in The Alternative, for a New Trial
In its special verdict, the jury determined that Syntron did not infringe the '484 patent. (Oct. 4, 2001 Special Verdict, at 1-2). Specifically, it found that Abbott has failed to prove that the accused products infringe the limitation "non-diffusively immobilized" in claims 22, 23 and 26; or the limitation "predetermined amount" of claim 26. (Id.).
The jury also ascertained that Abbott has not proved by a preponderance of the evidence that Syntron infringe the '162 patent. (Id., at 3-4). More precisely, the jury found that Syntron did not infringe the "non-diffusively bound" limitation of claim 1; the "predetermined amount" limitation of claims 22, 29 and 30; and the "specific for" limitation of claims 1, 22, 29 and 30. (Id.).
In its renewed motion for judgment as a matter of law, Abbott (1) attacks the Court's construction of the limitations "specific for", "non-diffusively immobilized," and "non-diffusively bound;" (2) asserts that the jury's findings as to all four disputed claim elements are unsupported by substantial evidence; (3) contends that the law of the case doctrine precluded the Court from modifying or clarifying its own rulings; and (4) submits that the Court erroneously applied the doctrine of prosecution history estoppel in this case. For those reasons, Abbott requests a judgment as a matter of law or, in the alternative, a new trial.
The Court, however, finds that all four of Abbott's contentions lack merit. To show why, the Court will address each of Abbott's contention in turn.
A. Legal Standards for Determining Infringement and for Construing Claims
Patent infringement analysis involves two steps. Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1476 (Fed. Cir. 1998). "First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process." Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993). See also Wang Laboratories, Inc. v. America Online, Inc., 197 F.3d 1377, 1380 (Fed. Cir. 1999); EMI Group North America, Inc. v. Intel Corp., 157 F.3d 887, 891 (Fed Cir. 1998).
When construing the terms of a patent, the Court must first turn to "intrinsic evidence." Intrinsic evidence includes the claim itself, the specification, and the prosecution history of the patent. Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Established rules of claim interpretation require that the Court first consider the words of the claims themselves, "both asserted and unasserted, to define the scope of the patented invention." Id. at 1582. The words are generally given their customary and ordinary meaning. Id.; Hoechst Celanese Corp. v. BP Chemicals, Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996) (stating that in defining technical terms, the Court should interpret it "as having the meaning it would be given by persons experienced in the field of the invention."). However, the Court must follow the definition of terms intended by the patentee if his or her special definition is clearly delineated in the specification or file history. Vitronics Corp., 90 F.3d at 1583; Hoechst Celanese Corp., 78 F.3d at 1578.
The Court also considers the specification to determine whether the inventor has employed any terms or words in a manner that is inconsistent with their plain and ordinary meaning. Vitronics, 90 F.3d at 1582. However, the claims, not the specification, define the invention so "not everything expressed in the specification must be read into all the claims." Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988) (quoting Raytheon Co. v. Roper Corp., 724 F.2d 951, 957 (Fed. Cir. 1983)).
The Court also may review the prosecution history of the patent, if admitted into evidence. Vitronics, 90 F.3d at 1582. This history is "the complete record of all the proceedings before the Patent and Trademark Office, including any express representations made by the applicant regarding the scope of the claims." Id. It also includes prior art which is cited in the file history. Id. at 1583.
The Court may resort to extrinsic evidence only if the intrinsic evidence is considered and there still remains some ambiguity as to the scope or meaning of the claim. Id. at 1583. This extrinsic evidence can include any evidence outside the patent and prosecution history such as prior art documents, dictionaries, technical treatises, articles, expert testimony, and inventor testimony. Id. at 1584. However, "extrinsic evidence in general, and expert testimony in particular, may be used only to help the court come to the proper understanding of the claims; it may not be used to vary or contradict the claim language." Id.
Although claim construction is a matter of law, Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc), the determination of infringement, whether literal or under the doctrine of equivalents, is a question of fact. Bai v. L L wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998). "In order for a court to find infringement, the plaintiff must show the presence of every [limitation] or its substantial equivalent in the accused device." Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994).
B. The "Specific For" Claim Limitation
Claims 1, 22, 29, and 30 of the '162 patent require a reactant that is "specific for" the analyte. The Court construed that limitation to mean "particular to and capable of binding with" the analyte or chemical moiety. (Jan. 5, 2001 Order). Specifically, the Court explained that:
The ordinary and customary meaning of "specific for" is having a fixed relationship with or being particular to the object in question. In this case, the term "specific for" is used in the claims to describe the relationship between the labeled antibody (or reactant) and the analyte or a chemical moiety to which it is supposed to bind. Therefore, the Court construes "specific for" as "particular to and capable of binding with" the analyte or chemical moiety.
(Id., at 3). The Court reaffirmed this construction during trial. (Sept. 25, 2001 Order Adopting Supplemental Claim Construction ("Sept. 25, 2001 Order"), at 2). Because the parties disputed what the phrase "particular to" in the Court's interpretation meant, the Court provided further clarification. (Id.). Adopting Abbott's proposed definition, the Court explained that "particular to" meant "capable of preferentially reacting or binding with the analyte or chemical moiety from among the thousands of molecules potentially in the test sample." (Id.).
But now that the jury found no infringement of that limitation, Abbott assigns error to the Court's construction of that term. Abbott further argues that, even if the Court reaffirmed that claim construction, the jury instruction contained confusing language that misled the jury. Abbott also argues that, under the Court's construction of the limitation, Syntron's capture antibody in the tests kits is "specific for" the analyte. All three of Abbott's contentions are without merit.
1. Claim Construction of The "Specific For" Limitation
There is no merit to Abbott's argument that the Court's interpretation of "specific for" is erroneous. The Court properly applied the controlling legal standards in construing the disputed claim terms. As it explained in its order,
when construing the terms of a patent, the Court must first turn to "intrinsic evidence." Intrinsic evidence includes the claim itself, the specification, and the prosecution history of the patent. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Established rules of claim interpretation require that the Court first I consider the words of the claims themselves, "both asserted and unasserted, to define the scope of the patented invention." Id. at 1582. The words are generally given their customary and ordinary meaning. Id.
(Jan. 5, 2001 order, at 2:12-18). As Abbott conceded in its moving papers and as the Court well understood, the term "specific for" must receive its ordinary and accustomed meaning because the '162 patent's specification neither defines nor limits the term. See York Prods., Inc. v. Central Tractor Farm Family Ctr., 99 F.3d 1568, 1572 (Fed. Cir. 1996) ("Without an express intent to impart a novel meaning to claim terms, an inventor's claim terms take on their ordinary meaning.").
To discern the ordinary and customary meaning of "specific for," courts may look to dictionary definitions of the word. Kopykake Enters. v. Lucks Co., 264 F.3d 1377, 1384 (Fed. Cir. 2001). Indeed, courts may always rely on dictionaries — even though they are a form of extrinsic evidence — to determine the meaning of the claim terms "so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents." Vitronics, 90 F.3d at 1584 n. 6. See also Interactive Gift Express v. Compuserve, Inc., 231 F.3d 859, 866 n.l (Fed. Cir. 2000); Optical Disc Corp. v. Del Mar Avionics, 208 F.3d 1324, 1334 (Fed. Cir. 2000) ("For such ordinary meaning, we turn to the dictionary definition of the term.").
The dictionary definitions of "specific for" include "having a real and fixed relationship to and usu. constituting a characteristic of . . . being peculiar to the thing or relation in question." Webster's Third New Int'l Unabridged Dictionary 2187 (1981) (abbreviation in original). This is the very definition upon which the Court relied in construing this term and in giving it its ordinary and accustomed meaning. Se Jan. 5, 2001 Order, at 3:9-10 ("The ordinary and customary meaning of "specific for' is having a fixed relationship with or being particular to the object in question."). The Court therefore properly applied the controlling law to the disputed terms of the '162 patent, and correctly construed "specific for" to mean "particular to and capable of binding with" the analyte or chemical moiety. Id., at 3:12-13.
Abbott, however, assigns error to the inclusion of the phrase "particular to" in the Court's claim construction of "specific for." To negate the term's ordinary and accustomed meaning, Abbott solely relies on extrinsic evidence — specifically testimony from Abbott's expert and other Syntron witnesses. (Trial Transcript ("Tr.") Vol. III at 118:20-120:20 and 116:6-116:21 (Dr. Harlow's Testimony); Tr. Vol. VII at 20:19-20:22 and 22:2-22:17 (Dr. David's testimony); Tr. Vol. VIII at 77:17-23 and 80:14 to 81:2 (Mr. Trinh's trial testimony); Tr. Vol. VIII at 4:16-4:18 and 5:10-5:21 (Dr. Lee's trial testimony)).
Because patent law limits the Court's use of extrinsic evidence in construing claims, the Court declines to adopt Abbott's broad construction of the term "specific for." "It is improper for a court to rely on extrinsic evidence such as expert testimony when construing disputed claim limitations." CAE Screedplates, Inc. v. Heinrich Fiedler GmbH Co. KG, 224 F.3d 1308, 1318 (Fed. Cir. 2000) (citingVitronics, 90 F.3d at 1584). In fact, "[i]n most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence." Vitronics, 90 F.3d at 1583. Only when intrinsic evidence alone is insufficient may the Court use extrinsic evidence, and then only to aid the Court in "coming to the proper understanding of the claims" and the technology involved. Id. at 1584. Extrinsic evidence may not be used to vary or contradict the claim language. Markman, 52 F.3d at 981. Despite this clear case law, Abbott would have the Court contradict the ordinary and accustomed meaning of the disputed term based solely on extrinsic testimonial evidence. The Court declines to take such improper action.
Furthermore, by eliminating the phrase "particular to" from the Court's construction, Abbott would have the term "specific for" mean "capable of binding with." Abbott, however, forfeited that broader meaning during the prosecution of its patent to overcome the patent examiner's patentability rejections. As the Court previously concluded, the patentee limited the broad term "capable of reacting" through successive narrowing amendments to avoid the PTO's rejections under 35 U.S.C. § 102, 103 and 112. (Oct. 3, 2001 Order Granting Syntron Bioresearch, Inc.'s Motion for Judgment as a Matter of Law that Prosecution History Estoppel Precludes any Equivalent for the Limitations "Specific for," "Non-Diffusively Immobilized" and "Non-Diffusively Bound," at 10-11). That forced narrowing process resulted in the term "specific for." (Id.). Abbott cannot now seek to recapture through claim construction what it has abandoned in response to the patent examiner's rejections for reasons of patentability. See Southwall Tech., Inc v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995) ("The prosecution history limits the interpretation of claim terms so as to exclude any interpretation that was disclaimed during prosecution."), cert. denied, 516 U.S. 987 (1995); Bell Atlantic Network Servs. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001) ("[Courts] must also examine the prosecution history to determine whether the patentee has relinquished a potential claim construction in an amendment to the claim or in an argument to overcome or distinguish a reference."); Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir. 1985) ("[T]he prosecution history (or file wrapper) limits the interpretation of claims so as to exclude any interpretation that may have been disclaimed or disavowed during prosecution in order to obtain claim allowance.").
Finally, during the hearing on the post-trial motions, Abbott argued that the Court has implicitly adopted Abbott's own interpretation of the disputed limitation in its October 9, 2001 Order. (See Oct. 9, 2001 Denying Without Prejudice Syntron Bioresearch, Inc.'s Motion for Judgment as a Matter of Law of Non-Infringement, at 4). Abbott's argument is, however, groundless because Abbott is reading the Court's October 9, 2001 Order out of context. In that Order, as it relates to the "specific for" limitation, the Court first declined Syntron's request to reconsider its well-settled interpretation of that term, and then explained that:
Given that interpretation, the evidence indicates that there is a triable issue of fact for the jury. In its case-in-chief, Abbott's expert testified that the 1001 antibody can react with both the LH and hCG molecules. Looking at the evidence in the light most favorable to Abbott as the Court must do, the Court finds that there are sufficient evidence in the record for a reasonable jury to determine that the 1001 antibody binds to and preferentially reacts with LH and hCG to [the] exclusion of other molecules in the solutions. The existence of such evidence requires a denial of the motion for JMOL based on the "specific for" limitation.
(Oct. 9, 2001 Order, at 4:11-4:17). The Court did not conclude, as Abbott submits, that the 1001 capture antibody is necessarily "particular to" LH and hCG. Rather, having applied the legal standards controlling a judgment as a matter of law, the Court determined that a reasonable jury might possibly reach that conclusion in light of the evidence. That determination led the Court to deny Syntron's motion without prejudice. When the Order is read in the proper context, Abbott's argument must fail because the Court neither changed its previous claim interpretation nor found that Syntron's products infringe Abbott's patents. Consequently, the Court concludes that Abbott's attack on the construction of the limitation "specific for" is without merit.
2. Jury Instruction Regarding "Specific For"
Abbott further finds errors in the Court's jury instruction regarding the term "specific for" and in Syntron's argument to jury about the application of that term. Abbott argues that, because the Court refused to add Abbott's requested explanation about what the claim term does not mean, Syntron took advantage of that gap by making improper arguments to the jury. The Court disagrees.
First, Abbott contends that the Court should have expressly instructed the jury about what "specific for" did not mean in addition to the Court's construction of what the term means. Abbott's contention has no merit.
The Court's duty under Markman is to construe the claim as a matter of law. See Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc). In this case, the Court has discharged that duty by clearly and objectively instructing the jury about the meaning of the term "specific for." See Jury Instruction No. 20; United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1564 (Fed. Cir. 1997) ("Jury instructions are reviewed for correctness, with due attention to their clarity, objectivity, and adequacy, taken as a whole.").
Despite its contention, Abbott cannot satisfy its burden to show that the Court's formulation of Jury Instruction No. 20, as it relates to the term "specific for," is legally erroneous or an abuse of discretion. To succeed in showing reversible legal error in a jury instruction, Abbott must show (1) that the jury instructions, read in their entirety, were incorrect and (2) that it requested instructions which could have eliminated the error. Delta-X Corp. v. Baker Hughes Production Tools, Inc., 984 F.2d 410, 415 (Fed. Cir. 1993); Goodwall Constr. Co v. Beers Constr. Co., 991 F.2d 751, 755 (Fed. Cir. 1993). As discussed above, Abbott has failed to show that the claim construction regarding "specific for" was incorrect. Nor has it shown that the jury instructions, read in their entirety, were incorrect. There was thus no legal error. Moreover, Abbott has not shown why the Court exceeded its discretion in selecting the formulation used in the jury instructions over Abbott's own version of the claim construction. If the Court had added Abbott's version, the jury instructions would have become more complicated, unwieldy, and difficult for the jury to comprehend. In the exercise of its discretion, it rejected Abbott's convoluted proposed instruction, and chose to adopt a clear, objective and simple formulation. KeyStone Retaining Wall Sys. Inc. v. Westrock, Inc., 997 F.2d 1444, 1449 (Fed. Cir. 1993) ("Challenges to the formulation [of jury instructions] adopted by the court are reviewed for abuse of discretion.") (quoting United States v. Beltran-Rios, 878 F.2d 1208, 1214 (9th Cir. 1989)); R. R. Dynamics, Inc. v. A. Stucki Co., 727 F.2d 1506, 1515 (Fed. Cir.) ("Regarding the form of the instructions, this court will reverse a judgment only if the trial court abused its discretion when selecting the manner in which to submit a case to the jury."), cert. denied, 469 U.S. 871 (1984). Therefore, Abbott has failed to show why the instruction was incorrect.
Second, Abbott contends that Syntron improperly appealed to the jury to reject the Court's claim construction and to interpret that term on its own. But, the record does not support that contention. In fact, Abbott can only point to a short excerpt in the record to buttress its view. (Tr. Vol. IX at 102:5-102:17). Considered in the proper context of the trial and the closing argument, that excerpt solely indicates that Syntron merely argued that its capture antibody did not infringe the patents-in-suit under the Court's claim interpretation. Syntron did not ask the jury to ignore the Court's claim construction.
Rather, the record shows that it was Abbott who raised the very argument it accuses Syntron of making. During the trial, Abbott raised the claim construction that the Court did not adopt in its questioning of Syntron's expert witness. (Tr. Vol. VII at 67:3-67:12). Then, Abbott reiterated the rejected claim construction in its closing argument. (Tr. Vol. IX at 29:3-29:11 and 30:1-30:7). Abbott thus bears the blame for raising the improper claim construction to the jury. In any case, considering the entire record of the trial, the Court concludes that there is no indication of any jury confusion as "to the term "specific for." There was only jury rejection of Abbott's misstatements.
3. Substantial Evidence Supports the Jury's Verdict as to "Specific For"
Abbott further argues that, under the claim construction of "specific for" given to the jury, Syntron's test kits infringe that claim limitation as a matter of law. Neither the record nor the law supports that contention.
To grant a judgment as a matter of law, Abbott "'must show that the jury's findings, presumed or express, are not supported by substantial evidence. . . .'" Pannu, 155 F.3d at 1348. In considering Abbott's showing, the Court must consider all the evidence and draw all reasonable inferences from the evidence in the light most favorable to Syntron.Richardson-Vicks, 122 F.3d at 1479. The Court may not determine the credibility of witnesses and must not "substitute its choice for that of the jury between conflicting elements of the evidence." Perkin-Elmer, 732 F.2d at 893. If, after this analysis, substantial evidence exists to support the jury's verdict, then the motion for JMOL must be denied. See Odetics, 185 F.3d at 1269.
Having considered the entire record, the Court determines that there is substantial evidence to support the jury's verdict that Syntron's products do not infringe the "specific for" limitation. The record shows that Syntron uses the 1001 capture antibody, which can bind to hCG and can cross-react with LH, on the test area of its pregnancy tests and ovulation tests. (Tr. Vol. VIII at 10:12-10:18 and 47:6-47:14; Tr. Vol. III at 7:15-7:22 and 139:8-142:25; Tr. Vol. VI at 196:10-202:12). The evidence indicates that 1001 antibody reacts with hGC — the analyte of interest in the pregnancy test — and LH — the analyte of interest in the ovulation test — because the antibody binds to an epitope of hCG that is also present in LH. (Tr. Vol. VIII at 2:23-4:20 and 47:6-47:14; Tr. Vol. III at 7:15-7:22, 8:3-9:6, 117:6-117:13, 139:8-142:25; Tr. Vol. VII at 161:16-163:1; Tr. Vol. VI at 196:10-202:12). However, the hormone LH may be present in a woman's urine, even if she is not pregnant, and thus cause unwanted cross-reactivity with the 1001 antibody in the pregnancy test. (Tr. Vol. VIII at 3:22-4:20; Tr. Vol. III at 11:17-12:15 and at 139:8-142:25; Tr. Vol. VII at 155:4-157:23 and 162:2-163:1; Tr. Vol. 196:10-202:12). To avoid LH cross-reactivity in its pregnancy test, Syntron uses a scavenger antibody that binds to LH but not to hCG in its pregnancy test. (Tr. Vol. VIII at 2:23-4:20; Tr. Vol. III at 7:15-7:22, 8:3-9:6, 117:6-117:13, 139:8-142.25; Tr. Vol. VII at 161:16-163:1; Tr. Vol. VI at 196:10-202:12). Based on such evidence, a reasonable jury could have found that Syntron's "capture antibody" found in the test zone is not "specific for," i.e., that it is not "particular to and capable of binding with" the hCG analyte.
Abbott points to excerpts of the witnesses testimony and to trial exhibits to support its contention that Syntron's products infringe the patents-in-suit. (Tr. Vol. VII at 60:24-61:3; Tr. Vol. VI at 100:16-100:25 and 101:25-102:11; Tr. Vol. X at 171:5-171:7; Trial Exh. 144, QuikPacII One Step Pregnancy Test Instructions; Trial Exh. 117, QuikStrip One Step hCG Pregnancy Test Instruction; Trial Exh. 111 A, Syntron's 510(K) FDA filing; Trial Exh. 148, Report for QuickPacII One Step hCG Test; Tr. Vol. II at 120:10-120:14; Tr. Vol. III at 115:21-116:5 and 116:8-116:21; Tr. Vol. II at 145:8-145:13 and 112:5-112:13; Tr. Vol. VI at 106:1-107:9; Tr. Vol. III at 12:2-12:7 and 126:2-126:11). In this case, the jury found non-infringement of the "specific for" limitation after hearing the trial testimony and considering all the evidence, including those cited by Abbott. In a judgment as a matter of law, the Court is not at liberty to substitute its own determination of the witnesses' credibility and assessment of conflicting evidence for those of the jury. See Perkin-Elmer, 732 F.2d at 893. Therefore, because substantial evidence exists to support the jury's findings, the Court declines Abbott's request to overturn the jury's verdict as to "specific for" and denies, in the exercise of its discretion, Abbott's motion for a new trial based on that claim limitation.
C. The "Non-Diffusively Bound" and "Non-Diffusively Immobilized" Claim Limitation
Claim 1 of the '162 patent requires a "non-diffusively bound" reactant, while claims 22 and 26 of the '484 patent includes the limitation "non-diffusively immobilized." At the parties' request, the Court construed those limitations:
The claim language makes clear that a "non-diffusively bound" reactant, as found in claim 1 of the '162 patent means a reactant immobilized in the reaction zone so as to provide a detectable signal indicating the presence or absence of analyte in the solution. A "non-diffusively bound" reactant is not capable of detaching from the medium, spreading out and moving along the test strip. . . . The specification also supports the construction of "non-diffusively bound" as immobilized on the test strip. See e.g., '162 patent, col. 15, lns. 16-27. "Non-diffusively immobilized," as found in claims 22 and 26 of the '484 patent, means the same thing as "non-diffusively bound."
(Jan. 5, 2001 Order, at 4 (citations omitted)). Reaffirming those constructions during trial, the Court reiterated that "non-diffusively bound" means "a reactant immobilized in the reaction zone so as to provide a detectable signal indicating the presence or absence of analyte in the solution and the reactant is not capable of detaching from the medium, spreading out and moving along the test strip." (Sept. 25, 2001 Order). The Court further underscored its previous ruling that "non-diffusively immobilized" means the same thing as "non-diffusively bound." (Id.).
Because the parties disagreed on the level of immobilization required by this claim construction and they requested further clarification, the Court reviewed the patent claims, their specification and their prosecution history. Having considered the controlling law and the patents, the Court ruled that "[a] reactant is non-diffusively bound only if it is bound in such a manner that a sufficient and reproducible amount of reactant remains bound in the reactive zone or zones to conduct both quantitative and qualitative assays." (Id., at 3).
Now, Abbott challenges those claim constructions and asserts that, even if the construction of those two terms were correct, Syntron infringes the patents-in-suit. Those challenges lack merit.
1. Claim Constructions of "Non-Diffusively Bound" and "Non-Diffusively Immobilized"
Abbott contends that the additional claim construction refinement that the Court provided in its September 25, 2001 order was erroneous. It focuses on the Court's ruling that "[a] reactant is non-diffusively bound only if it is bound in such a manner that a sufficient and reproducible amount of reactant remains bound in the reactive zone or zones to conduct both quantitative and qualitative assays." (Sept. 25, 2001 Order, at 3). Abbott argues that the phrase "to conduct both quantitative and qualitative assays" in that ruling contravened the Court's previous rulings by improperly reading into the claims an extraneous "quantitative" limitation. Abbott is mistaken.
It is true that the Court has previously determined that the asserted patent claims do not require a quantitative measurement of the analyte, and that a purely qualitative test may infringe the patents-in-suit. (Aug. 2, 2000 Amended Order, at 17; Sept. 28, 2000 Order, at 5-8 ("After engaging in a thorough re-analysis of the issue, the Court concludes that Claim 22 covers both qualitative and quantitative assays.")).
The Court was well aware of those previous determinations when it ruled on the supplemental claim construction disputes in its September 25, 2001 Order. For instance, in the papers submitted in relation to the supplemental claim construction request, Syntron asked the Court to redefine the term "analyte" to mean "a substance that is to be measured quantitatively." But, the Court denied Syntron's request and reaffirmed its previous construction that "analyte" is "simply the substance of interest, i.e., the substance that the test is designed to detect, if present in the liquid being tested." (Sept. 25, 2001 Order).
However, the Court's August 2, 2000 and September 28, 2000 orders on which Abbott relies focused on whether the pervasive quantitative references in the claims and written description limited the claims to only quantitative tests. (Aug. 2, 2000 Amended Order, at 17; Sept. 28, 2000 Order, at 5-8). They did not address whether the patent claims completely exclude quantitative tests. (Id.).
Yet, Abbott erroneously reads those rulings and the patents-in-suit as entirely excluding quantitative tests. It is well-settled that a claim construction that would exclude the preferred embodiment "is rarely, if ever, correct and would require highly persuasive evidentiary support."Vitronics, 90 F.3d at 1583. See also Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1343 (Fed. Cir. 2001); Modine Mfg. Co. v. United States Int'l Trade Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996) ("[A] claim interpretation that would exclude the inventor's device is rarely the correct interpretation; such an interpretation requires highly persuasive evidentiary support. . . ."); Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575, 1581 (Fed. Cir. 1996) ("We share the district court's view that it is unlikely that an inventor would define the invention in a way that excluded the preferred embodiment, or that persons of skill in this field would read the specification in such a way."). The written description of the patents-in-suit discloses, among the preferred embodiments, quantitative tests. See, e.g., '484 patent, col. 2, ln. 3-5 (describing under the Summary of the Invention section that "[i]n one embodiment, the invention provides an apparatus for thequantitative analysis of a chemically reactive substance. . . .") (emphasis added); '162 patent, col. 1 ln 66 to col. 2 ln. 1 (same text). In fact, one of the goals of this patent was to teach such quantitative analysis. See '484 patent, col. 1, ln. 63-65 ("It would be highly desirable to provide a quantitative test for chemical moieties. . . .") (emphasis added); '162 patent, col. 1, ln. 59-60 (same text). And the inventors squarely placed the inventions in the field of quantitative testing. See '484 patent, col. 1, ln. 10-11 ("The invention is in the field of quantitative chemical analysis. . . .") (emphasis added); '162 patent, col. 1, ln. 10-11 (same text). Thus, the inventors unequivocally contemplated a quantitative embodiment, and the Court's claim construction must include it.
The Court's reference to a quantitative assay in its September 25, 2001 supplemental claim construction was therefore not erroneous. The refined construction in no way limits the patent's coverage to only quantitative assays, as Abbott contends. Rather, the Court's construction allows for quantitative assays in addition to qualitative tests. Such permissive interpretation is necessary in light of the controlling law and the patent specification. Abbott's attack on the Court's supplemental claim construction of "non-diffusively bound" and "non-diffusively immobilized" is therefore without support.
2. Substantial Evidence Supports the Jury's Verdict as to "Non-Diffusively Bound" and "Non-Diffusively Immobilized"
Abbott also submits that, even under the Court's claim construction, Syntron's test kits would still infringe. It first points to some evidence presented during the trial and asserts that, under its own reading of the "plain wording of the claims," Syntron's test kits allegedly quantify the analyte. (Trial Exh. 117, QuikStrip One Step hCG Pregnancy Test Instruction; Trial Exh. 144, QuickPacII OneStep Pregnancy Test Instructions; Trial Exh. 145, BeSure OneStep Pregnancy Test instructions; Tr. Vol. VIII at 68:3-68:6; Trial Exh. 111A, Syntron's 510(K) FDA filing; 21 C.F.R. § 862.1156; Tr. Vol. II at 57:2-57:11). Even if the test kits did not quantify the analyte, Abbott submits that a sufficient amount of reactant remains immobilized in the test zone for the tests to function correctly and for Syntron's test kits to infringe the patents-in-suit. (Tr. Vol. VIII at 77:3-77:6 and 69:14-69:20; Trial Exh. 117, QuikStrip OneStep hCG Pregnancy Test Instructions; Tr. Vol. II at 135:3-135:17, 128:5-128:22 and 129:1-129:20).
But, Abbott has already presented those arguments and evidence to the jury. And, the jury has rejected them. The record indicates that, because the 1001 antibody is only attached to the test zone through weak non-covalent bonds, some of the antibodies could flow away from the test zone. (Tr. Vol. VIII at 57:21-58:11; Tr. Vol. VI at 171:19-173:23 and 176:5-177:20). Based on such substantial evidence, the jury could properly infer that the reactant was "capable of detaching from the medium, spreading out and moving along the test strip" and was not "non-diffusively."
The inferences against quantification and reproducibility were also supported by substantial evidence. The testimony indicates that some variability exists in the amount of 1001 antibody that flows away from the test line. (Tr. Vol. VIII at 59:22-60:1; Tr. Vol. VI at 171:19-173:23 and 176:5-177:20). The evidence further suggests that the amount of 1001 capture antibody that remains in the test zone is unknown and variable. (Tr. Vol. VI at 171:19-173:23 and 176:5-177:20; Tr. Vol. III at 39:13-39:16). The testimony about Syntron's production process further indicated that the process does not permit quantitative tests which require minimal and known variances from test to test. (Tr. Vol. III at 39:13-40:8; Tr. Vol. VI at 171:19-172:15 and 176:5-177:20; Tr. Vol. VIII at 61:25-63:7). A reasonable jury could have concluded that Syntron's tests was not quantitative as Abbott asserts. The jury could also reasonably infer that, given the variability in the amount of 1001 capture antibody in the test zone, the amount of reactants in the reaction zone was neither sufficient nor reproducible from tests to tests to satisfy the literal meaning of the disputed terms.
Based on the application of the prosecution history estoppel doctrine, the Court limited infringement of the limitations "non-diffusively bound" and "non-diffusively immobilized" to literal infringement, and precluded the application of the doctrine of equivalents to those two terms. See Oct. 3, 2001 Order Granting Syntron Bioresearch, Inc.'s Motion for Judgment as a Matter of Law that Prosecution History Estoppel Precludes any Equivalent for the Limitations "Specific for," "Non-Diffusively Immobilized" and "Non-Diffusively Bound."
In light of the entire record and the applicable legal standards, the Court determines that Abbott has not met its burden for a judgment as a matter of law and has not shown the requisite proof to obtain a new trial based on the terms "non-diffusively bound" and "non-diffusively immobilized." See Perkin-Elmer, 732 F.2d at 893. Rather, Abbott is simply relitigating its case by presenting in its papers evidence that the jury has already considered and rejected. In doing so, it is asking the Court to substitute its views for those of the jury or to grant a new trial so that it can have another bite at the apple. In light of the controlling legal standards, the Court declines to do so. See Applied Medical Resources, 147 F.3d at 1376; Digidyne Corp., 734 F.2d at 1347.
D. The "Predetermined Amount" Limitation
Claim 26 of the '484 patent requires a "reaction zone having non-diffusively immobilized therein a predetermined amount of a reactant . . ." and further calls for a "reaction zone, wherein detection occurs in the reaction zone only if analyte is present in the test solution in apredetermined amount. . . ." (emphasis added). Claims 22, 29 and 30 of the '162 patent provides for an assay where "each zone having apredetermined amount of a reactant bound to it . . ." (emphasis added). At the parties' request, the Court construed the term "predetermined amount" to mean an "amount determined beforehand." (Aug. 2, 2000 Order, at 20-21; Sept. 28, 2000 Order, at 8; Sept. 25, 2001 Order, at 5).
Although the jury found no infringement of that limitation, Abbott still maintains that Syntron's products use a predetermined amount of reactant and detect a predetermined amount of analyte. Specifically, Abbott argues that Syntron applies to each test strip an amount of 1001 capture antibody — at least 2.0 microgram per test — that is both controlled and determined in advance. (Tr. Vol. VIII at 69:4-69:13, 67:20-67:22, 68:3-68:6 and 80:2-80:13; Trial Exh. 148, Document Report for QuikPac II OneStep hCG Test for Urine Only, at S19166; Trial Exh. 122-125, Syntron Production Records). According to Abbott, that predetermined amount was sufficient to meet FDA standards by detecting a concentration of 25 mIU/ml of hCG in a sample of urine. (Tr. Vol. VIII at 69:13-69:20, 67:20-67:22, and 68:3-68:6; Trial Exh. 144, QuikPac II OneStep Pregnancy Test Instruction; Trial Exh. 117, QuikStrip OneStep hCG Pregnancy Test Instructions). However, Abbott misstates the proper context of the patent claim and the weight of the evidence.
First, as to the "predetermined amount" of reactant, the entire thrust of Abbott's argument implicitly assumes that "predetermined amount" means an "amount measured in advance," regardless of whether the amount of reactant is ultimately bound to the reaction zone. The patent claims, however, expressly requires that the "predetermined amount" of reactant be either bound to the test zone or be non-diffusively immobilized. ('484 patent, col. 18, ln. 42-43; '162 patent, col. 17, ln. 25-27; '162 patent, col. 18, ln. 27-30). Abbott's broad interpretation cannot contradict the express terms of the patent claims, and cannot therefore be correct.
There is also substantial evidence to support the jury's findings that the bound, or non-immobilized, amount of reactant was not predetermined. The record suggests that the amount of bound antibody is unknown and variable from test to test. (Tr. Vol. VIII at 51:9-63:1; Tr. Vol. VI at 171:19-173:23 and 176:5-177:20; Tr. Vol. III at 39:13-39:16). But, despite this uncertainty, Syntron's tests still function adequately. (Tr. Vol. VIII at 42:9-87:6). Syntron's manufacturing process merely involves placing the 1001 capture antibody solution on the test strip, and "eyeballing" it to make sure that the solution is on it. (Tr. Vol. VIII at 56:17-57:20). Thus, a reasonable jury could have found that the amount of bound reactant was not determined beforehand.
Second, as to the "predetermined amount" of analyte in the '484 patent, Abbott has not satisfactorily shown that Syntron's tests only measure an analyte concentration at or above 25mIU. There is substantial evidence to support the jury's determination that the amount of hCG was not determined beforehand: Syntron's pregnancy test kits register a positive result both below and above 25 mIU of hCG. (Tr. Vol. VIII at 65:2-67:4; Tr. Vol. VII at 69:1-69:16). There is also substantial evidence that Syntron's tests can yield a positive result when there is only 5 mlU or as much as 3,000,000 mIU of hCG present. (Tr. Vol. VIII at 65:15-67:4).
In sum, the jury's findings as to the "predetermined amount" was fully supported by substantial evidence. Abbott has presented contradicting evidence and argument to the jury. But, the jurors rejected Abbott's claims, and the Court is not at liberty to overturn the jury's verdict under this context. See Nobelpharma, 141 F.3d at 1065. Moreover, the jury's findings were not contrary to the clear weight of the evidence, based on false evidence, or a miscarriage of justice. Consequently, the Court declines to grant a new trial. See Richardson, 868 F.2d at 1245.
E. Relitigation of The "Non-Diffusively Bound/Immobilized" and "Predetermined Amount"
According to Abbott, the Court violated the doctrine of the "law of the case" in asking the jury to determine whether Syntron has infringed the "non-diffusively bound/immobilized" and "predetermined amount." Abbott, however, misunderstands and misapplies that doctrine.
First, Abbott is mistaken in stating that the Court is without power to change its rulings before final judgment. Courts have the inherent power to modify their interlocutory orders before entering a final judgment.Marconi Wireless Telegraph Co. v. United States, 320 U.S. 1, 47-48 (1943); John Simmons Co. v. Grier Brothers Co., 258 U.S. 82, 88 (1922);Balla v. Idaho State Bd. of Corrections, 869 F.2d 461, 465 (9th Cir. 1989). In addition, the Federal Rules of Civil Procedure explicitly grant federal courts the authority to modify their interlocutory orders. Fed.R.Civ.P. 54(b) (stating that any order which is not certified under Rule 54(b) and which adjudicates fewer than all the claims as to all the parties "is subject to revision at any time before the entry of [final] judgment"). Accordingly, the Court could have modified its August 2, 2000 Order at any time before entry of final judgment because that order constituted a non-final, interlocutory order.
Second, Abbott errs in arguing that the law of the case principle precludes any modification or clarification of the Court's previous rulings. "[T]he law of the case doctrine 'merely expresses the practice of courts generally to refuse to reopen what has been decided, not a limit to their power.'" Mendenhall v. Barber-Greene Co., 26 F.3d 1573, 1582 (Fed. Cir. 1994) (quoting Messemger v. Anderson, 225 U.S. 436, 444 (1912)). Under the principles of law of the case, courts adhere to a decision in a prior appeal absent exceptional circumstances, such as a change in the controlling law, clear error in the earlier decision resulting in manifest injustice, or substantially different evidence at a subsequent trial. Mendenhall, 26 F.3d at 1582. The doctrine does not preclude a district court from modifying or clarifying its previous rulings, unless an appellate court found otherwise. As the Federal Circuit explained:
Law of the case, then, merely requires a trial court to follow the rulings of an appellate court. It does not constrain the trial court with respect to issues not actually considered by an appellate court, and thus has long been held not to require the trial court to adhere to its own previous rulings if they have not been adopted, explicitly or implicitly, by the appellate court's judgment.Exxon Corp. v. United States, 931 F.2d 874, 877 (Fed. Cir. 1991) (citations and footnotes omitted) (emphasis in original). Thus, Abbott misunderstood the doctrine when it claimed that the law of the case doctrine prohibited the Court from modifying its own interlocutory orders.
In addition to functioning differently from the way Abbott contends, the law of the case doctrine is actually inapplicable to this case because the Court has not modified its claim construction. The claim construction for "predetermined amount" as provided in the Sept. 25, 2001 Order is identical to the construction issued in the Court's August 2, 2000 Amended Order and reaffirmed in its September 28, 2000 Order. (Sept. 25, 2001 Order, at 5 (citing Aug. 2, 2000 Amended Order, at 20-21; Sept. 28, 2000 Order, at 8)). Moreover, the interpretation of the terms "non-diffusively bound" and "non-diffusively immobilized" did not undergo any change either. The September 25, 2001 Order that provided a compendium of claim constructions to-date reiterated and cited the Court's previous interpretation of those terms. (Sept. 25, 2001 Order, at 2-3 (citing Jan. 5, 2001 Order, at 4)). Because during trial the parties disputed the level of immobilization required by the Court's construction, the Court provided the requested clarification. (Sept. 25, 2001 Order, at 2-3). That clarification did not change the previous ruling, but rather elucidated the ambiguity the parties perceived in the Court's original claim construction. (Id.; Jan. 5, 2001 Order, at 4).
During trial, Abbott actually attempted to modify the Court's construction of "non-diffusively immobilized/bound" by urging a broader and inappropriate interpretation of those terms. (Tr. Vol. VIII at 212:4-212:20; Abbott's Amended Separate Claim Chart of Proposed Claim Construction Rulings (filed Sept. 25, 2001), at 2-3 and 5). Abbott cannot now claim prejudice due to a lack of notice from a clarification that Abbott itself requested and in which it was a willing participant.
Furthermore, Abbott cannot claim prejudice from the Court's submission of the infringement determination to the jury. The Pre-Trial Order submitted by the parties and issued by the Court on June 22, 2001 clearly indicated that the infringement of the "non-diffusively bound/immobilized" and "predetermined amount" terms were disputed issues of fact for the jury. (June 22, 2001 Pre-Trial Order, at 10-11). Abbott's counsel was responsible for preparing that Pre-Trial Order, and approved it as to form and content. See. Civ. L. R. 16.1(f)(6) (a c); Jun. 22, 2001 Pre-Trial Order, at 21 (showing signature of Abbott's lead counsel approving the Pre-Trial Order as to form and content). It is specious for Abbott to claim that it was surprised and prejudiced by a decision to which it was a willing participant.
Thus, Abbott has not shown any reason for the Court to overturn the jury based on the doctrine of the law of the case. Nor has Abbott shown any prejudice from the submission of the infringement determinations to the jury. Accordingly, the Court declines to reverse the jury's findings or to grant anew trial. Odetics, 185 F.3d at 1269; Hanson, 541 F.2d at 1359.
F. The Court's Ruling on Prosecution History Estoppel
As its final ground for a judgment as a matter of law or a new trial, Abbott attacks the Court's ruling on the issue of prosecution history estoppel ("PHE"). But, Abbott first raises that issue in its reply brief, thereby precluding Syntron from opposing Abbott's attack. Such approach is improper and the Court has the discretion to disregard the improperly raised argument. See United States v. Boyce, 148 F. Supp.2d 1069, 1085 (S.D. Cal. 2001) ("This argument was not presented in their moving papers and therefore should not be considered now, as it is improper for a party to raise a new argument in a reply brief."). See also United States v. Bohn, 956 F.2d 208, 209 (9th Cir. 1992) (noting that courts generally decline to consider arguments raised for the first time in a reply brief."); United States v. Boggi, 74 F.3d 470, 478 (3d Cir. 1996) (noting that considering arguments raised for first time in reply brief deprives opposing party of adequate opportunity to respond); Playboy Enters., Inc. v. Dumas, 960 F. Supp. 710, 720 n. 7 (S.D.N.Y. 1997) ("Arguments made for the first time in a reply brief need not be considered by a court.").
Although Abbott's action is improper, the Court will nonetheless address those arguments for the sake of completeness. On its merits, Abbott's attack on the PHE ruling must fail because it misreads the law and rehashes arguments that the Court previously rejected.
To bolster its attack, Abbott heavily relies on Turbocare Div. of Demag Delaval Turbomachinery Corp. v. General Electric. Co., 264 F.3d 1111, 1125-26 (Fed. Cir. 2001), for the proposition that PHE does not apply where the disputed claim limitation first appeared in an original claim that was canceled and then reappears in a newly added claim. Relying on that reading of the Turbocare, Abbott contends that the Court must reconsider its PHE order.
However, Abbott overlooks a deciding factor in Turbocare. In that case, the original application claim did not contain the word "contact" which was later added after the cancellation of the original claim to clarify a particular limitation. Id., at 1125. The Federal Circuit found that no narrowing of the claims occurred in that case because, although the original claim did not include the "contact" limitation, the original specification clearly showed the "contact" idea. Id., at 1126. The Federal Circuit concluded that "the newly added claim only redefined the small clearance position limitation without narrowing the claim." Id. (emphasis added). Accordingly, the original claim as read in light of the specification already included the narrow limitation, and the amendment that apparently narrowed the scope of that claim merely redefined that original claim. See id.
In this case, no such "redefinition" occurred; the patentee clearly narrowed the scope of the "specific for" during prosecution. In its October 3, 2001 Order, the Court carefully detailed how the patentee's successive amendments during prosecution narrowed the scope of that limitation from "capable of reacting" to "specific for." (Oct. 3, 2001 Order Granting Syntron Bioresearch's Motion for Judgment as a Matter of Law That Prosecution History Estoppel Precludes Any Equivalent to Limitations "Specific For," "Non-diffusively Immobilized" and "Non-diffusively Bound," at 9-10). The Court further explained that the narrowing amendments were made to create an interference for priority purposes under 35 U.S.C. § 102 (g) and to avoid the examiner's rejection under 35 U.S.C. § 102, 103 and 112. (Id., at 11-12). In other words, the narrowing amendments related to "specific for" occurred for reasons of patentability and triggered PHE under both Festo and rulings overturned by Festo. (Id.). Similarly, the patentee narrowed the scope of the "non-diffusively immobilized" and "non-diffusively" for reasons of patentability. (Id., at 9-13).
Nothing in the specification indicates that the inventors intended for the original claims to be as narrow as they became after prosecution. For the "specific for" limitation, Abbott cites two excerpts from the '162 patent specification to take advantage of the Turbocare rule. But, those excerpts are specious, since the words "specific" used there has a different meaning than the limitation "specific for" in the claims-in-suit. See '162 patent, col. 3, ln. 22-25 ("[T]he invention employs immunochemical reactions in which the analyte and the reactant represent different parts of a specific ligand-antibody (antiligand) binding pair. . . .") (emphasis added); id., col. 12, ln. 30-32 (stating that the labeled antibody is "exposed to the immobilized analyte to form the specific binding complex. . . .") (emphasis added). When read in context, those excerpts do not prove that the inventors contemplated the limitation "specific for" in the patent disclosure. They only show that the word "specific" rather than "specific for" appears in the written description. No redefinition of the original claim occurred. Abbott cannot twists the meaning of the patent specification to hide the fact that the patentee has made narrowing amendments for reasons of patentability.
Abbott mistakenly asserts that the specification of '484 and '162 patents contained the narrower "non-diffusively immobilized" and "non-diffusively bound" limitations respectively. It, however, fails to cite a single excerpt from the patent specifications to buttress its case. The Court has carefully reviewed those specifications and has found nothing to support Abbott's assertion. Consequently, the Court concludes that Turbocare is inapplicable to this case.
Finally, none of Abbott's remaining argument convinces the Court to depart from its Oct. 3, 2001 ruling. First, the Court has already considered and rejected Abbott's argument that "specific for" appeared in a dependent claim in the original "459 Application. (Oct. 3, 2001 Order, at 12). There is thus no need to rethread on well-worn grounds.
Second, Abbott contends that the term "specific for" existed in the prior art and could not provide the reason for the narrowing amendments. That contention blindly ignores the prosecution history of the "specific for" limitation and the patentee's unambiguously narrowing amendments adopted to secure an interference and to avoid the examiner's rejection under §§ 102, 103 and 112. (Id., at 2-4 (discussing prosecution history of the "specific for" limitation)).
Third, Abbott submits that the term "specific for" in the '162 patent was not added for reasons of patentability because the asserted claims in the '484 patent do not have that limitation. That argument is misleading because the narrowing amendments occurred long after the "229 Application, that eventually issued as the '484 patent, was filed. In fact, the "932 Application that gave rise to the '162 patent was a continuation of a divisional of the "229 Application. (Oct. 3, 2001 Order, at 3). The patentee filed the "229 Application in 1983, while the "932 Application arose in 1992. (Id., at 2-3). And, the patentability reasons leading to the narrowing amendments occurred in 1992 and 1995 respectively, long after the prosecution of the "229 Application was underway. (Id., at 3-4). Abbott is comparing apples and oranges to serve its own purpose, and the Court declines to adopt that improper comparison.
Abbott has failed to show any legal error in the Court's October 3, 2001 Order. Consequently, the Court reaffirms its previous ruling that the doctrine of prosecution history estoppel precludes Abbott from asserting any equivalent to the claim terms "specific for," "non-diffusively immobilized," and "non-diffusively bound."
G. Summary of Rulings as to Abbott's Post-Trial Motions
In sum, Abbott has not satisfied its burden to show that the jury's verdict of non-infringement of to the claim limitations "specific for," "non-diffusively immobilized," "non-diffusively bound," and "predetermined amount" was unsupported by substantial evidence. Its attacks on the Court's claim construction of those terms also lack merit. Because the Court sees no error in the jury's determinations, it declines in the exercise of its discretion to grant Abbott's requested new trial. Therefore, the Court DENIES Abbott's Motion for a Judgment as a Matter of Law, or in the Alternative, for a New Trial.
In addition, in its opposition papers, Syntron has requested that Exhibits R, S, U and V to Abbott's Notice of Lodgment be filed under seal and be immediately stricken from the public records. Syntron submits that those documents — essentially production reports and test instructions — are highly confidential and that Abbott violated the protective order in using those documents as exhibits. In its reply, Abbott did not oppose that request or dispute Syntron's allegations. In addition, the record indicates that the Court has admitted those exhibits into evidence under seal because they were subject to the protective order. (See, e.g., Tr. Vol. III at 187:6-187:10; Tr. Vol. VI at 120:1-120:17). Therefore, the Court will order the Clerk to file those exhibits under seal.
II. Syntron's Renewed Motion for Judgment as a Matter of Law
In its special verdict, the jury determined that Syntron has not proved by clear and convincing evidence that the claims-in-suit were invalid due to anticipation under 35 U.S.C. § 102, obviousness under 35 U.S.C. § 103, inventorship under 35 U.S.C. § 102 (f), and lack of proper written disclosure under 35 U.S.C. § 112. (Oct. 4. 2001 Special Verdict, at 4-6). In addition, the jury rendered a finding that Syntron has not proved by clear and convincing evidence that the claims-in-suit were unenforceable due to inequitable conduct. (Id., at 7).
Syntron now challenges the jury's findings of invalidity. It contends that all asserted claims of the '484 patent and '162 patent are invalid either for failure to satisfy the written description requirement, for anticipation, for obviousness, or for failure to name the proper inventors. Syntron further requests that the Court reconsiders its construction of the term "diffusively bound" and grants it a judgment as a matter of law of non-infringement of that limitation. In light of the controlling law and the facts of this case, the Court declines to grant Syntron's requested motion for judgment as a matter of law.
A. Legal Standards for Determining Invalidity
A party seeking to invalidate a patent must overcome a presumption that the patent is valid. 35 U.S.C. § 282; United States Gypsum Co. v. National Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1375 (Fed. Cir. 1986). This presumption places the burden on the challenging party to prove the patent's invalidity by clear and convincing evidence. United States Gypsum Co., 74 F.3d at 1212.
The challenging party's burden also includes overcoming deference to the PTO's findings and decisions in prosecuting the patent application. Deference to the PTO is due "when no prior art other than that which was considered by the PTO examiner is relied on by the attacker." American Hoist Derrick Co. v. Sowa Sons, 725 F.2d 1350, 1359 (Fed. Cir.), cert. denied, 469 U.S. 821 (1984). Conversely, no such deference is due when the party challenging the patent raises prior art or evidence that was not considered by the PTO in its decision and evaluation of the patent application:
When an attacker simply goes over the same ground traveled by the PTO, part of the burden is to show that the PTO was wrong in its decision to grant the patent. When new evidence touching validity of the patent not considered by the PTO is relied on, the tribunal considering it is not faced with having to disagree with the PTO or with deferring to its judgment or with taking its expertise into account.Id., at 1360.
B. Invalidity for Failure to Satisfy the Written Description Requirement 1. Written Description Requirement Legal Standards
Title 35 U.S.C. § 112 requires that a patent provides a written description of the invention. That statute expresses the written description requirement as follows:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to i enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.35 U.S.C. § 112, paragraph 1.
The Federal Circuit has articulated three major purposes for the written description requirement. First, the requirement aims to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification. See Reiffin v. Microsoft Corp., 214 F.3d 1342 (Fed. Cir. 2000). Second, it also prevents inventors from obtaining early priority dates for claims to subject matter that was not contemplated at the time the parent application was filed. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991) (quotingRengo Co. v. Molins Machinery Co, 657 F.2d 535, 551 (3d Cir. 1981) ("Adequate description of the invention guards against the inventor's overreaching by insisting that he recount his invention in such detail that his future claims can be determined to be encompassed within his original creation.")). Third, and more importantly, it serves "to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him." In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996) (citing In re Wertheim, 541 F.2d 257, 262 (C.C.P.A. 1976)).
Hence, in order to satisfy the written description requirement, the patent specification must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) ("The description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). See also Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566 (Fed. Cir. 1997);Vas-Cath, 935 F.2d at 1563.
"One shows that one is "in possession' of the invention by describing the invention, with all its claimed limitations . . . by such descriptive means as words, structures, figures, diagrams, formulas, etc." Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (emphasis omitted). See also In re Wertheim, 541 F.2d at 262 ("The primary consideration is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure."). "That a person skilled in the art might realize from reading the disclosure that such a step is possible is not sufficient indication to that person that the step is part of the applicant's invention." In re Winkhaus, 527 F.2d 637, 640 (C.C.P.A. 1975) (emphasis in original). The claimed invention, however, need not be described in ipsis verbis in order to satisfy the written description requirement. See Application of Lukach, 442 F.2d 967, 969 (C.C.P.A. 1971). See also In re Wright, 866 F.2d 422, 425 (Fed. Cir. 1989) ("[T]he claimed subject matter need not be described in haec verba in the specification in order for that specification to satisfy the description requirement.").
The written description requirement is separate from the enablement and best mode requirements, which are also contained in 35 U.S.C. § 112.In re alton, 76 F.3d at 1176; Vas-Cath, 935 F.2d at 1563-64. In order to be considered enabling, a patent must give persons of ordinary skill in the relevant art enough information to practice the invention disclosed in the specification without undue experimentation. In re Goodman, 11 F.3d 1046, 1050 (Fed Cir. 1993). The best mode requirement mandates that the inventor disclose the best mode known to him or her at the time the patent application is filed. Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1535 (Fed. Cir.), cert. denied, 484 U.S. 954 (1987). With the written description requirement, "the question is not whether [one skilled in the art] would be so enabled but whether the specification discloses the compound to him, specifically, as something appellants actually invented." In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967). See also In re DiLeone, 436 F.2d 1404, 1405 (C.C.P.A. 1971) ("It is possible for a specification to enable the practice of an invention as broadly as it is claimed, and still not describe that invention.").
The issue of whether the written description requirement has been satisfied is a question of fact. See Suntiger, Inc. v. Scientific Research Funding Group, 189 F.3d 1327, 1334 (Fed. Cir. 1999); Tronzo v. Biomet Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) ("Because the issue of whether the written description requirement has been satisfied is a question of fact, we must determine whether substantial evidence supports the jury's verdict that the requirement has been met."). In order to succeed, a challenger must therefore provide clear and convincing evidence to the trier of facts that persons skilled in the art would not recognize in the disclosure a description of the claimed invention. See In re Alton, 76 F.3d at 1175.
2. Substantial Evidence Supports the Jury's Findings as to The Written Description Requirement
The application of those legal standards precludes the Court from disturbing the jury's determination that claims 9-30 of the '162 patent are not invalid for failure to satisfy the written description requirement. Indeed, the Court construed the term "diffusively bound labeled antibody" in the '162 patent to mean "a labeled antibody bound to the solid medium in such a way that it is capable of detaching from the medium, spreading out, and moving along the test strip." (Sept. 28, 2000 Order, at 14). On this issue, there is substantial evidence to support the jury's determination that the written description discloses that limitation as construed by the Court.
The patent specification contains disclosures upon which a reasonable jury could rely to render its verdict of non-invalidity at issue. First, the written description mentions labeled antibodies as required by the limitation. ('162 patent, col. 12, ln. 8-24 ("Antibody against a polyvalent antigen is labeled with peroxidase. . .")). Second, the specification describes the term "reactant" as including antibodies. (Id., col. 3, ln. 22-25 and col. 8, ln. 13-16). Third, the summary of the invention in the written description further teaches that the reactant, when immobilized in each reaction zone, is capable of binding with the analyte. (Id., col. 2, ln. 2-14). Fourth, a described preferred embodiment apparatus contains reactants that are held in a region antecedent to the reaction zone and that can "[be] flowed" or "carried with the liquid carrier and analyte. . . ." (Id., col. 12 ln. 62 to col. 13 ln. 15; col. 13, ln. 9-12). In that preferred embodiment, the reactants are present on the medium so that "all that is required is that the analyte in a liquid carrier be flowed through the apparatus." (Id., col. 13, ln. 2-4). Finally, there is substantial evidence that the jury read the written description as one of skill in the art would have because it heard testimony about how the skilled artisan in that field would read the patent specification. (Tr. Vol. II at 156-157, 77:22-79:9 and 100:10-101:11; Tr. Vol. VII at 78:12-78:16, 80:13-80:19, and 81:25-82:11). Therefore, drawing all inferences in the light most favorable to Abbott as the Court must, the Court concludes that the jury relied on the substantial evidence available in the '162 patent's written description to reach its verdict.
None of Syntron's arguments to the contrary compels the grant of a judgment as a matter of law. Syntron asserts that claims 9-30 of the '162 patent are invalid for failure to adequately describe the disputed limitation. It argues that the term "reactant" is too broad to include "antibody." ('162 patent, col. 2, ln. 21-30; col. 7, ln. 8-40; col. 8, ln. 14-15). Syntron further challenges the adequacy of the two main passages in the written description upon which Abbott relics. It charges that the soluble glucose oxidase antibody teaching involves a two-step assay where the antibody is not part of the claimed apparatus. It also impeaches Example VI as lacking any teaching about a labeled antibody or about how that antibody would normally work. Finally, Syntron submits that there is no inherent disclosure of any "diffusively bound labeled antibody" in the written description. In essence, Syntron asks the Court to determine the witnesses' credibility and substitute its choice for that of the jury where the evidence are conflicting. Under the controlling standards for granting a judgment as a matter of law, the Court cannot do so. Perkin-Elmer, 732 F.2d at 893; Odetics 185 F.3d at 1269.
In addition, Syntron submits that the Court must apply the doctrine of collateral estoppel and grant Syntron a judgment as a matter of law on this issue. Citing Judge O'Toole's grant of partial summary judgment in the Selfcare case, Syntron asserts that collateral estoppel precludes Abbott from assert claims 9-30 of the '162 patent against Syntron. But, the Court already considered that argument and rejected it because the Court determined that Judge O'Toole's ruling did not constitute a final judgment that gave rise to collateral estoppel under Ninth Circuit law. (Nov. 16, 2000 Order, at 3-4). Judge O'Toole's recent order denying Abbott's motion for reconsideration of his previous written description ruling in the Selfcare case is still not a final judgment that would create collateral estoppel in this case. (See Jan. 7, 2002 Syntron Bioresearch, Inc.'s Request for Judicial Notice in Support of Its Renewed Motion for Judgment as a Matter of Law (providing copy of docket from theSelfcare case)). Without any new legal ground or factual evidence to compel a departure from a previous ruling, the Court declines to reconsider its previous ruling on that issue. The doctrine of collateral estoppel is inapplicable here and insufficient to reverse the jury's verdict on the written description requirement.
In sum, substantial evidence supports the jury's determination that the written description discloses the claim term "diffusively-bound labeled antibody," and none of Syntron's arguments has proved otherwise. Therefore, the Court declines to grant Syntron's requested judgment as a matter of law on this factual issue.
C. Invalidity Based on Anticipation 1. Anticipation Legal Stapdards
A patent is "anticipated" by a prior publication if "the invention was . . . described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for patent in the United States." 35 U.S.C. § 102 (b).
An anticipation analysis involves a three-part inquiry: the trier of fact must first determine whether the challenging reference is prior art. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576-78 (Fed. Cir. 1996); Del-mar Eng'g Lab v. United States, 524 F.2d 1178, 1184 (Ct.Cl. 1975). Second, the fact finder must ascertain that the prior art is enabling as to put the invention in the public's possession. Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471, 1479 (Fed. Cir. 1986), cert. denied, 482 U.S. 909 (1987). Prior art patent references are presumed enabled. In re Sasse, 629 F.2d 675, 681 (C.C.P.A. 1980). Third, the trier of fact must ascertain whether the doctrine of identity applies, i.e., whether each element of the accused claim is present either expressly or inherently in a single prior reference. Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 771 (Fed. Cir. 1983), cert. denied, 465 U.S. 1026 (1984).
In this case, the anticipation inquiry focus on the Deutsch patent, which issued approximately five years before the patents-in-suit were filed. (Tr. Vol. VII at 86:21-87:6). As a prior art patent, the Deutsch patent is presumed to be enabled, and neither party has disputed that point. See In re Sassee, 629 F.2d at 681. The only anticipation issue is whether the doctrine of identity is satisfied.
Under the doctrine of identity, "anticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim." Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 716 (Fed. Cir. 1984). Invalidity by anticipation results if each and every element of the claimed invention appears in a single prior art reference published more than one year before the filing date of the challenged patent. Scripps Clinic Research Fnd. v. Genentech. Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991); Verdegaal Brothers Inc. v. Union Oil Company of California, 814 F.2d 628, 631 (Fed. Cir. 1987). In other words, "that which infringes if later, anticipates if earlier." Polaroid Corp. v. Eastman Kodak Co., 789 F.2d 1556, 1573 (Fed. Cir. 1986) (citing Peters v. Active Mfg. Co., 129 U.S. 530, 537 (1889)). If even one element is missing from the prior art, there can be no finding of anticipation. Kalman, 713 F.2d at 772; Studiengesellschaft Kohle, m.b.H. v. Dart Industries, Inc., 726 F.2d 724, 726-27 (Fed. Cir. 1984).
Anticipation is a question of fact. Minnesota Mining Mfg. Co. v. Johnson Johnson Orthopaedics, Inc., 976 F.2d 1559, 1565 (Fed. Cir. 1992); In re Baxter Travenol Labs, 952 F.2d 388, 390 (Fed. Cir. 1991);Chester v. Miller, 906 F.2d 1574, 1576 (Fed. Cir. 1990); Allen Archery, Inc. v. Browning Manufacturing Co., 819 F.2d 1087, 1091 (Fed. Cir. 1987).
2. Substantial Evidence Supports the Jury's Findings as to Anticipation
In this case, substantial evidence supports the jury's determination that Syntron failed to prove by clear and convincing evidence that the Deutsch patent contained each and every limitation of the claims-in-suit. During the trial, Syntron's expert witness admitted that the Deutsch patent did not disclose a diffusively bound labeled antibody in particular, or the patented assays in general. (Tr. Vol. VII at 87:7-90:17 and 88:19-88:25 ("I don't think that a person of ordinary skill in the art could have taken the teaching of the Deutsch patent and created, without undue experimentation, an assay that would satisfy the requirements of the '484 and '162 patent.") respectively). He also stated that Deutsch did not disclose two-antibody sandwich assays. (Tr. Vol. VII at 101:21-101:24). Syntron's expert further testified that the Deutsch patent uses a developing fluid to drive the sample along the strip, thereby requiring at least two steps in its assay. (Tr. Vol. VII at 95:4-98:25). As Abbott's expert explained, the liquid that drives the capillary flow through the Deutsch invention does not contain the analyte. (Tr. Vol. III at 100:5-101:24). Rather, the analyte is added at a separate spot, and the developing fluid which comes in a second step drives the sample along. (Id.). Therefore, the jury could have relied on any of those differences to determine that the Deutsch patent did not contain every limitation of the disputed claims.
U.S. Patent No. 4,094,647 (issued June 13, 1978).
Nonetheless, Syntron seeks a judgment as a matter of law that the Deutsch patent anticipates the patents-in-suit. It argues that the Deutsch patent's use of a developing fluid in the two-step assay constitutes the only difference between that prior art and the litigated patents. It then contends that, under a proper claim construction, the claims-in-suit are not limited to a one-step assay. Alternatively, it submits that, even if the claims include such a limitation, the Deutsch patent would be anticipating.
Syntron essentially requests a post-trial claim construction, and the Court declines to grant that request. First, the Court has not received adequate briefing to properly adjudicate that issue. Second, even if the Court adopted Syntron's requested construction, that ruling would be superfluous since it only disposes of one of the potential reasons why the jury found no anticipation. In other words, Syntron's requested claim construction fails to address Dr. David's testimony that the Deutsch patent does not teach the "diffusively bound labeled antibody" limitation or the two-antibody sandwich assay idea. The testimony on either point constitutes substantial evidence that supports the jury's verdict.
In ruling on a judgment as a matter of law, the Court is not at liberty to substitute its own views or credibility determinations for the jury's findings of facts. Stryker Corp. v. Davol, Inc., 234 F.3d 1252, 1257-58 (Fed. Cir. 2000). Therefore, Syntron's motion for a judgment as a matter of law that the patents-in-suit are anticipated must fail.
D. Invalidity eased on Obviousness 1. Obviousness Legal Standards
Title 35 U.S.C. § 103 precludes the grant of a patent that is obvious to one of skill in the art. That statute provides that:
if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.35 U.S.C. § 103. The ultimate determination of obviousness is a question of law based on underlying factual inquiries. Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997); Specialty Composites v. Cabot Corp., 845 F.2d 981, 989 (Fed. Cir. 1988). Those factual inquiries involve consideration of the four Graham factors: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the pertinent art; and (4) any secondary considerations of nonobviousness, such as commercial success. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966); B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1582 (Fed. Cir. 1996).
The existence of each limitation of a claim in the prior art does not, by itself, demonstrate obviousness, because obviousness may not be established using hindsight. Kahn v. General Motors Corp., 135 F.3d 1472, 1479 (Fed. Cir. 1998). Instead, there must be a "reason, suggestion, or motivation in the prior art that would lead one of ordinary skill in the art to combine the references, and that would also suggest a reasonable likelihood of success." Smiths Indus. Med. Sys., Inc. v. Vital Signs, Inc., 183 F.3d 1347, 1353 (Fed. Cir. 1999). "Such a suggestion or motivation may come from the references themselves, from knowledge by those skilled in the art that certain references are of special interest in a field, or even from the nature of the problem to be solved." Id. at 1356.
In determining obviousness, the invention must be considered as a whole and the claims must be considered in their entirety. Kahn, 135 F.3d at 1479-80. Moreover, Syntron must prove invalidity as a result of obviousness by clear and convincing evidence. United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1564 (Fed. Cir. 1997).
2. Syntron Failed To Prove by Clear and Convincing Evidence that The Patents-in-Suit Are Obvious
In this case, Syntron argues that the combination of the Deutsch patent with the Tom patent renders the patents-in-suit obvious. But, Syntron's argument fails for a number of reasons. First, Syntron did not offer a limitation-by-limitation presentation of the Graham factors. See Arkie Lures, Inc. v. Gene Larew Tackle, Inc., 119 F.3d 953, 955-60 (Fed. Cir. 1997) (reversing a conclusion of obviousness because the district court failed to consider all the Graham factors). Rather, its entire obviousness case focused on the issue of whether there was a motivation to combine the Tom and Deutsch patents.
U.S. Patent No. 4,366,241 (issued December 28, 1992).
Second, the combination of the two prior art references would, at best, dispose of the use of a developing fluid in the Deutsch's two-step assay. It does not address the fact that the "diffusively bound labeled antibody" limitation or the two-antibody sandwich assay idea.
Third, none of Syntron's witnesses provided a valid motivation for combining the Tom and Deutsch prior art. Syntron's expert could only point to the fact that the Tom patent cites the Deutsch patent as a prior art reference. (Tr. Vol. VII at 104:23-106:1). That fact is insufficient to serve as a motivation to combine the references. Neles-Jamesbury, Inc. v. Fisher Controls Int'l. Inc., 4 F. Supp.2d 41, 44 n. 2 (D. Mass. 1998) (finding that a numerical citation of a prior art patent in another patent did not amount to a motivation to combine). Syntron counters that the motivation to combine can come from the nature of the problem to be solved or the knowledge of one of skill in the art. But, it fails to provide any testimony or evidence showing that the nature of the problem compels the combination of those patents. In such evidentiary vacuum, neither the jury nor the Court could accept that argument. As to the inherent knowledge of one of skill in the art, Syntron has failed to show that the skilled artisan would have a special interest in those patents or expect some reasonable likelihood of success when combining those two patents. See Smiths Indus Med., 183 F.3d at 1353 (requiring that there must be a "reason, suggestion, or motivation in the prior art that would lead one of ordinary skill in the art to combine the references, and that would also suggest a reasonable likelihood of success.") (emphasis added).
Those weaknesses in Syntron's obviousness case constitute substantial evidence to support the jury's determination that Syntron has failed to show by clear and convincing evidence that the patents-in-suit were invalid for obviousness. The jury could have determined that the differences between the prior art and the patents at issue were too great. Although obviousness is an ultimate issue of law, the Court finds no clear and convincing reason to disturb the jury's reasonable verdict on this issue.
E. Invalidity Based on Inventorship 1. Inventorship Legal Standards
The issuance of a patent creates a presumption that the named inventors are the true and only inventors of the subject matter of the patent. See Ethicon Inc. v. United States Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998). However, omission of an inventor can invalidate a patent unless the omission was an error "without any deceptive intention." 35 U.S.C. § 256 (permitting the correction of inventorship errors if made without any deceptive intent); 35 U.S.C. § 102 (f) (invalidating patent if the inventor "did not himself invent the subject matter sought to be patented."); Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1576 (Fed. Cir. 1997). This rule applies because, when an invention is the work of several inventors, they must jointly apply for the patent. 35 U.S.C. § 116 ("When an invention is made by two or more persons jointly, they shall apply for a patent jointly."); 35 U.S.C. § 111.
"Inventorship is a question of who actually invented the subject matter claimed in a patent." Sewall v. Walters, 21 F.3d 411, 417 (Fed. Cir. 1994) (quoting Beech Aircraft Corp. v. EDO Corp., 990 F.2d 1237, 1248 (Fed. Cir. 1993)). "Conception is the touchstone of inventorship."Burroughs Wellcome, 40 F.3d 1223, 1227 (Fed. Cir. 1994). Accordingly, each person claiming to be a joint inventor must have contributed to the conception of the invention. Fina Oil Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997).
Beyond conception, a purported inventor must show that he made "a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the frill invention, and [did] more than merely explain to the real inventors well-known concepts and/or the current state of the art." Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998). A co-inventor need not make a contribution to every claim of a patent. See 35 U.S.C. § 116. A contribution to one claim is enough. See SmithKline Diagnostics, Inc. v. Helena Lab. Corp., 859 F.2d 878, 888 (Fed. Cir. 1988).
To prove that contribution, "the alleged co-inventor or co-inventors must prove their contribution to the conception of the claims by clear and convincing evidence." Ethicon, 135 F.3d at 1461. However, "[t]he case law is unequivocal that an inventor's testimony respecting the facts surrounding a claim of derivation or priority of invention cannot, standing alone, rise to the level of clear and convincing proof." Price v. Symsek, 988 F.2d 1187, 1194 (Fed. Cir. 1993).
The purported inventor must provide corroborating evidence of his contribution. Id. "Whether the inventor's testimony has been sufficiently corroborated is evaluated under a 'rule of reason' analysis. Under this analysis, 'an evaluation of all pertinent evidence must be made so that a sound determination of the credibility of the [alleged] inventor's story may be reached.'" Ethicon, 135 F.3d at 1461 (quoting Price v. Symesek, 988 F.2d 1187, 1195 (Fed. Cir. 1993)). Corroborating evidence may come in the form of contemporaneous documents prepared by the alleged inventor, circumstantial evidence about the inventive process, or oral testimony from someone other than the alleged inventor. Ethkon, 135 F.3d at 1461. However, it is not necessary to corroborate every factual issue contested by the parties. See id. at 1464.
"Inventorship is a question of law that [a court] reviews without deference." Acromed Corp. v. Sofamore Danek Group. Inc., 253 F.3d 1371, 1379 (Fed. Cir. 2001) (citing Ethicon, 135 F.3d at 1460). This ultimate issue of law, however, involves factual predicates that a court must review with deference. Ethicon, 135 F.3d at 1560; Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997); Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994).
2. Syntrom Failed To Prove by Clear and Convincing Evidence that The Patents-in-Suit Are Invalid Based on Inventorship
In this case, the issue of inventorship focuses on whether Dr. Brian Lee conceived of the material in the patent or merely reduced to practice what Drs. Guire and Swanson conceived. After evaluating all the pertinent evidence, the jury determined that Dr. Lee's claims of inventorship did not rise to the level of clear and convincing evidence. The Court finds no compelling reason to disturb the jury's findings.
The facts surrounding the conception and patenting of the patents-in-suit are instructive in evaluating the propriety of the jury's determination. In the Fall of 1981, BSI — the patentee that granted the exclusive license to the patents-in-suit to Abbott — was developing tests usable without laboratory instrumentation or training. (Tr. Vol. III at 166:4-169:12). Among other assays, BSI was trying to develop a field test for penicillin in cow milk. (Id.). While working on that problem, Dr. Guire conceived of the "migration binding banded assay" on the evening of Friday, September 25, 1981, on his drive home from work. (Tr. Vol. III at 170:11-170:23). He called Dr. Swanson that evening to discuss the new idea. (Tr. Vol. III at 170:19-170:23).
His journal provided a contemporaneous corroboration of that testimony. (Tr. Vol. III at 170:11-172:19; Trial Exh. 60A, Dr. Guire's diary entry of Sept. 25, 1981). Dr. Guire testified that his September 25, 1981 diary entry record reflected his idea of the migration binding banded assay, in which the user would apply the sample to a disk of filter paper and the sample would migrate through bands of antibody capable of binding to the analyte. (Tr. Vol. III at 173:15-174:8).
On Monday September 28, 1981, Dr. Guire presented his idea to the weekly BSI staff meeting. (Tr. Vol. III at 174:9-175:8; Trial Exh. 60A, Dr. Guire's diary entry of Sept. 28, 1981). He believed that he could apply the new idea to the assay for penicillin in milk. (Tr. Vol. III at 175:9-13; Trial Exh. 60A, Dr. Guire's diary entry of Sept. 28, 1981). Brian Lee was, however, absent from the staff meeting because he had worked the previous day on another experiment. (Tr. Vol. III at 175:25-176:12; Trial Exh. 60A, Dr. Guire's diary entry of Sept. 28, 1981). Dr. Lee, who was then still a graduate student, worked in the BSI research laboratories under the directions of Drs. Guire and Swanson. (Tr. Vol. IX at 99:1-99:12).
At the next staff meeting on October 6, 1981, Dr. Guire again discussed the immuno-migration assay idea. (Tr. Vol. IV at 4:5-25; Trial Exh. 60A, Dr. Guire's diary entry of Oct. 6, 1981). Dr. Swanson and Brian Lee attended that meeting on October 6, 1981. (Id.). Dr. Guire then directed his staff to reduce the idea to practice. (Tr. Vol. IV at 5:21-6:15). He assigned to Mel Swanson the development of the column-format assays, and to Brian Lee the task of implementing the idea using paper strips or circles. (Id.). Dr. Guire assumed the responsibility of designing the scope of the work, determining the priority of the tasks, and evaluating their results. (Id.). During this work, Dr. Lee did not introduce the idea of the banded assay to Drs. Guire and Swanson. (Tr. Vol. IX at 113:10-114:19). Rather, as Dr. Lee testified, it was Dr. Swanson who conceived of the banded assay. (Tr. Vol. IX at 120:3-120:25). Thus, the jury reasonably inferred that Dr. Lee's development of the paper assay did not constitute conception, but mere reduction to practice under Dr. Guire's directions.
It is true that BSI submitted pages from Dr. Lee's notebook to the Board of Patent Appeals and Interferences to support its claim of priority in the Zuk v. Swanson interference. (Trial Exh. 1300A, Preliminary Statement of Swanson and Guire, Zuk v. Swanson Interference No. 101,667; Tr. Vol. X at 86:17-91:19). But, Dr. Lee's written description and drawings that were submitted to the Board merely constituted proof of the requisite reduction to practice for purpose of the interference. In other words, those laboratory notebook pages only showed that Dr. Lee reduced part of the invention to practice; they do not prove that he conceived of the invention. Ethicon, 135 F.3d at 1460. ("[O]ne does not qualify as a joint inventor by merely assisting the actual inventor after conception of the claimed invention.") (citing Sewall, 21 F.3d at 416-17). See also Shatterproof Glass Corp. v. Libbey-Owens Ford co., 758 F.2d 613, 624 (Fed. Cir. 1985) ("An inventor 'may use the services, ideas and aid of others in the process of perfecting his invention without losing his right to a patent.'") (citations omitted). In light of all the pertinent evidence, those submissions did not clearly and convincingly prove that Dr. Lee actually conceived of the invention. Because "[c]onception is the touchstone of inventorship[,]" Burroughs Wellcome, 40 F.3d at 1227, the failure to rebut the presumption that the patent correctly named the inventors means that Dr. Lee is not one of the inventors for purpose of invalidity under 35 U.S.C. § 102 (f). Consequently, Syntron's request for judgment as a matter of law based on inventorship must be denied.
F. Non-Infringement of The "Diffusively Bound" Limitations
Finally, Syntron requests that the Court reconsiders its construction of the "diffusively bound labeled antibody" in light of the Court's clarification of the term "non-diffusively bound," and grants Syntron as judgment as a matter of law of non-infringement of that limitation. The Court declines to do so.
First, Syntron has failed to advance any proper ground for its request for reconsideration. A motion for reconsideration "is appropriate if the district court (1) is presented with newly discovered evidence, (2) committed clear error or the initial decision was manifestly unjust, or (3) if there is an intervening change in controlling law." School Dist No. 1J, Multnomah County v. ACandS, Inc., 5 F.3d 1255, 1263 (9th Cir. 1993). It is within the discretion of the district courts to grant or deny reconsideration. United States v. Desert Gold Mining Co., 433 F.2d 713, 715 (9th Cir. 1970). In its papers, Syntron has not shown any change in Federal Circuit law requiring that the Court reconsidered its claim construction. Nor has Syntron provided any newly discovered evidence contradicting the claim construction. It has not even shown any clear error to support its request for reconsideration, except for Syntron's own erroneous interpretation of the Court's claim construction. Under the applicable law, Syntron has failed to make the requisite showing for reconsideration. In the exercise of its discretion, the Court denies Syntron's request. Desert Gold Mining Co., 433 F.2d at 715.
Second, even if the Court were to reexamine its claim construction of the term "diffusively bound" based on its clarification of the term "non-diffusively bound," it would reaffirm that ruling. As the Court explained above in addressing Abbott's motion for judgment as a matter of law, the refined construction of the term "non-diffusively bound" complied with the controlling law and the teachings of the patents-in-suit to allow for quantitative assays in addition to qualitative tests. It did not indicate a departure from the Court's previous claim constructions. In fact, in its September 25, 2001 Order, the Court unequivocally repeated its well-settled interpretation of "non-diffusively bound" in addition to the parties' requested clarification of the level of immobilization required by that interpretation. Consequently, Syntron's request is misguided and must be denied.
Syntron's request for reconsideration of the Court's September 28, 2000 ruling is also untimely. The Southern District of California's Local Rule 7.1(i)(2) places a thirty-day limit on such motions. Civ. L. R. 7.1(i)(2) ("Except as may be allowed under Rules 59 and 60 of the Federal Rules of Civil Procedure, no motion or application for reconsideration shall be filed more than 30 days after the entry of the ruling, order or judgment sought to be reconsidered."). Syntron has filed the papers containing this request for reconsideration on October 22, 2001, despite the fact that the Court entered the challenged order on September 28, 2000. More than a year has elapsed between the Court's September 28, 2000 Order and Syntron's request, thereby placing the reconsideration motion outside of the thirty-day limit provided by the local rules.
G. Summary of Rulings as to Syntron's Post-Trial Motions
In sum, Syntron has not satisfied its burden to show by clear and convincing evidence that the jury's findings that the patents-in-suit were not invalid under 35 U.S.C. § 102, 103, 112. Substantial evidence support the jury's determinations on the factual issues of anticipation and written description requirements. The jury's verdict as to obviousness and inventorship deserves deference because it is based on the record, and the Court declines to depart from those sensible determinations on those issues of law. As to Syntron's request for reconsideration of the Court's claim construction of the term "non-diffusively bound," the Court concludes that the request is inadequate under the law controlling reconsideration and without merit. Therefore, the Court DENIES Syntron's Motion for a Judgment as a Matter of Law.
CONCLUSION
Having considered the controlling law, the parties' arguments, and the totality of the evidence, the Court DENIES (1) Abbott Laboratories' Motion for Judgment as a Matter of Law, or in the Alternative, for a New Trial, and (2) Syntron Bioresearch, Inc.'s Motion for Judgment as a Matter of Law.
In ruling on these post-trial motions, the Court has reviewed the entire record of this case and all the evidence presented at trial. For reasons of judicial efficiency, this Order only cites to portions of the record and the evidence that are most germane to the issues raised by the parties. Accordingly, although it has not cited every exhibit or testimony that may be relevant to those issues, the Court has considered the totality of the evidence in reaching the present rulings.
Furthermore, for good cause shown, the Court orders the Clerk of Court to file under seal Exhibits R, S, U and V attached to Abbott's Notice of Lodgment of Evidence in Support of its Renewed Motion for Judgment as a Matter of Law or, in the Alternative, for a New Trial.
Finally, the Court commends the parties' attorneys for their performance in the prosecution of this case. The Court particularly compliments the attorneys for the high quality of their briefs, their presentation of the evidence, their ability to explain a complex technology to a lay jury, their oral advocacy, and their overall courtesy and professionalism during the course of this litigation.
IT IS SO ORDERED.