INOVA Diagnostics, Inc. v. Euro-Diagnostica AB et al

Filing 129

Claim Construction Order for United States Patent Number 7,335,724. Signed by Judge Marilyn L. Huff on 08/24/09. (ag) (jrl).

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA INOVA DIAGNOSTICS, INC., a California Corporation, Plaintiff / Counterclaim-Defendant, vs. EURO-DIAGNOSTICA AB, a corporation of Sweden; AXIS-SHIELD DIAGNOSTICS LTD, a corporation of Scotland; STICHTING VOOR DE TECHNISCHE WETENSCHAPPEN, an institution of the Netherlands; EURODIAGNOSTICA BV, a corporation of the Netherlands, Defendants / Counterclaim-Plaintiffs. On August 21, 2009, the Court conducted a claim construction hearing in this matter for U.S. Patent No. 7,335,724. Morgan Chu, David Gindler, Erin McCracken, Amir Naini, and Lucy Stark appeared on behalf of the Plaintiff. Anders Aannestad, Gregory Reilly, and Steven Comer appeared on behalf of the Defendant. After due consideration of the parties' briefing, submitted evidence, and the testimony at the hearing, the Court issues the following claim construction order. /// /// -108cv845 CASE NO. 08-CV-0845 H (JMA) CLAIM CONSTRUCTION ORDER FOR UNITED STATES PATENT NUMBER 7,335,724 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 I. Claim Construction Legal Standard The claims of a patent define the scope of the patented invention. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996). In construing claim terms, a court must determine the meaning of any disputed words from the perspective of one of ordinary skill in the pertinent art at the time of filing. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). There is a heavy presumption that claim terms carry their "ordinary and customary" meanings. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). The "ordinary and customary" meaning is that which a person of ordinary skill in the art would understand the term to mean at the time of invention. Phillips, 415 F.3d at 1313. The person of ordinary skill in the art is "deemed to read the claim term not only in the context of the particular claim . . . but in the context of the entire patent, including the specification." Id. The use of the term in both asserted and unasserted claims may shed light on the meaning of a particular term. Id. at 1315. If the meaning of a term is not readily apparent, the court must then look to other intrinsic evidence to define the term. See id. at 1314. A court must read claims "in view of the specification, of which they are a part." Markman, 52 F.3d 967, 979 (Fed. Cir. 1995). The specification "is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics, 90 F.3d at 1582. Although the specification is useful in determining the meaning of a term, a court must not import limitations from the specification into the claim. Phillips, 415 F.3d at 1323. A court may also consult the prosecution history, if in evidence, during claim construction. The prosecution history "provides evidence of how the PTO and the inventor understood the patent." Phillips, 415 F.3d at 1317. However, the prosecution history is the result of a negotiation between the inventor and the patent office and therefore "often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. -2- 08cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Extrinsic evidence "is less reliable than the patent and its prosecution history in determining how to read claims." Phillips, 415 F.3d at 1318. Indeed, "intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language." Vitronics, 90 F.3d at 1583. A court may only rely on extrinsic evidence in claim construction when the intrinsic evidence fails to resolve ambiguity in disputed claim terms. Id. at 1583. II. Construction of Disputed Terms The Court's constructions are set forth in the chart below. The Court first explains the reasoning behind its constructions of certain disputed terms. A. "An antigen" The parties agree that the "antigen" of claim 1 is something to which an antibody binds. (Pl.'s Br. at 8; Def.'s Br. at 6.) The only dispute is whether the antigen in claim 1 should be construed as a "substance to which antibodies bind" according to the Plaintiff's construction or as "a molecule to which antibodies bind" as in Defendants' construction. The "words of a claim are generally given their ordinary and customary meaning" "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention." Phillips, 415 F.3d at 1312. In this case, Defendant has not shown that the word "antigen" limits the invention to a molecule. If such a limitation exists, it stems from language following the term "antigen." See Hitzeman v. Rutter, 243 F.3d 1345, 1349 (Fed. Cir. 2001) (discussing a different antigen "comprised of a cluster of protein molecules"). Accordingly, because Plaintiff's construction is an accurate definition of the term and is consistent with all intrinsic evidence, the Court adopts it. B. "consisting of a cyclic peptide" Claim 1 states that the claimed antigen consists of a cyclic peptide. `724 Patent col.15 l.23. The parties dispute whether this language limits the claim to exactly one cyclic peptide. The Court concludes that it does. The phrase "consisting of" is "a term of patent convention meaning that the claimed invention contains only what is expressly set forth in the claim. However, while `consisting of' limits the claimed invention, it does not limit aspects unrelated to the invention." Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331 (Fed. Cir. 2004) -308cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ("Norian I") (citation omitted). For example, the Norian I court held that, where a patent claimed a kit for preparing a calcium mineral "consisting of" several chemicals, the kit was limited to the claimed chemicals and no other chemicals. Id. Because a spatula was not part of the described invention, its presence in such a kit was irrelevant. Id. at 1332. Plaintiff argues that, because claim 1 refers to "a cyclic peptide," it is limited to only one such peptide. In patent construction, the "question whether `a' or an' is treated as singular or plural depends heavily on the context of its use." TIVO, Inc. v. Echostar Commc'ns Corp., 516 F.3d 1290, 1303 (Fed. Cir. 2008). The Federal Circuit typically interprets "a" in its singular sense when "used in conjunction with the closed transitional phrase `consisting of.'" Norian Corp. v. Stryker Corp., 432 F.3d 1356, 1359 (Fed. Cir. 2005) ("Norian II"); see also Abbott Labs v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 1281 (Fed. Cir. 2003) ("[A]lthough `a' without more generally could mean one or more in an open-ended patent claim, `a' with `consisting of' in this case indicates only one member of a Markush group."). In Norian II, the Federal Circuit held that "the claim language `consisting of . . . a sodium phosphate,' on its own, suggests the use of a single sodium phosphate." Norian II, 432 F.3d at 1359. Here, the `724 Patent claims an antigen "consisting of a cyclic peptide." col.15 l.23. As in the Norian cases, this language suggests the use of a single cyclic peptide as the invention itself. Defendant has not shown why a deviation from this convention is warranted in this case. Defendant argues that the claim language and specification of the `724 Patent show that "a peptide" refers to one or more peptides. (Def.'s Br. at 9, Def.'s Resp. Br. at 9.) As Defendant points out, the specification states that "two or more peptides according to the invention may be part of one oligopeptide." `724 Patent col.3 l.42-44. However, the fact that an oligopeptide is created from the combination of two peptides does not mean that, once formed it is two peptides. Instead, the specification's reference to "one oligopeptide" suggests that it is still one peptide; the "oligo-" prefix designates the origin of the molecule, not its nature. Accordingly, the specification language relied upon by Defendant does not support its argument that claim 1 is not limited to one peptide. -4- 08cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Defendant further argues that, because the peptide of claim 1 is a fragment, and the fragment can be made up of multiple peptides, claim 1 is not limited to one peptide. (Def.'s Br. at 9-10.) However, the Court does not agree that the fragment of claim 1 can be multiple peptides. The parties agree that a "cyclic peptide" is a peptide that includes one or more bonds contributing to looped structures in the chain. (Doc. No. 105 at 2.) The parties dispute the nature of the bonds that form these loops. Plaintiff argues that these must be covalent bonds, while Defendant objects to such a limitation. (Pl.'s Br. at 14; Def.'s Br. at 10.) Declining to import this limitation into the claim, the Court agrees with Defendant. Plaintiff points out that the specification of the `724 Patent describes only cyclic peptides containing covalent bonds specifically, disulfide bridges between cysteine side chains.1 col.2 l.25-27; col.5 l.60-63. However, it is improper to confine patent claims to the preferred embodiment. Phillips, 415 F.3d at 1323 ("[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments."). Moreover, the specification of the `724 Patent states that bond between cysteine residues is provided as an example. col. 2 l.25-27 ("According to a favourable embodiment the peptide is a cyclic peptide, for instance, due to the presence of a cysteine residue.") In prosecuting the `724 Patent, the patentee intended that claim 1 encompass "a cyclic peptide, regardless of the means of its cyclization" stating that "the important aspect here is that a cyclic peptide is formed, not how it is formed." (Aannestad Decl. ISO Def.'s Br. Ex. C at 31.) "Even where a patent describes only a single embodiment, claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope." Saunders Group, Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1332 (Fed. Cir. 2007). Here, in light of the open language of the specification and prosecution history, the patentee has not Covalent bonds involve the sharing of electrons between atoms, as opposed to hydrogen bonds (interaction between positively charged hydrogen atoms and atoms with a 28 negative charge) and van der Waals interactions (caused by temporarily uneven charge distributions). 1 -5- 08cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 demonstrated a clear intention to require covalent bonds. The Court concludes that, "after reading the entire patent," an ordinary artisan in the relevant field would construe the ordinary meaning of "cyclic peptide" as a sequence of amino acids, that includes one or more bonds that form one or more looped structures in the peptide. Phillips, 415 F.3d at 1321. The parties also dispute whether the cyclizing bonds "form one or more looped structures" or "cause the peptide to form one or more looped structures." (Doc. No. 105 at 2.) Defendant objects to Plaintiff's use of the word "cause," arguing that this construction improperly requires that the bond initiate the looping process. (Def.'s Br. at 12-13.) However, Plaintiff disclaims any temporal aspect to its construction. Accordingly, this dispute turns on a distinction without a difference. The parties agree that the cyclizing bonds keep the loops in place, and the Court's construction conveys this idea. C. "a fragment" Claim 1 states that the claimed peptide is "a fragment if filaggrin." `724 Patent col.15 l.23-24. Plaintiff argues that the term "fragment" is indefinite in the context of claims 1 and 8. (Pl.'s Br. at 17-18.) Plaintiff requests that the Court defer construction of this term until after it has considered Plaintiff's forthcoming motion for summary judgment on the issue of indefiniteness. The Court declines to defer construction. A claim is indefinite "only if reasonable efforts at claim construction prove futile." Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1347 (Fed. Cir. 2005). Here, the Court construes this term to possess its "ordinary and customary meaning" an incomplete part. Phillips, 415 F.3d at 1312. This construction is consistent with the prosecution history of the `724 Patent. The claim that became claim 1 was previously rejected by the patent examiner because it read only upon the full-length filaggrin protein put into cyclic form. (Aannestad Decl. Ex. C at 43.) In response, the patentee amended the claim to cover fragments, "not the cyclic form of the entire amino acid sequence." (Id. at 48, 50.) The prosecution history of a patent is relevant to construction, as it "provides evidence of how the PTO and the inventor understood the patent." Phillips, 415 F.3d at 1317. -6- 08cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 The Court's construction does not preclude Plaintiff's indefiniteness argument. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1251 (Fed. Cir. 2008) ("Even if a claim term's definition can be reduced to words, the claim is still indefinite if a person of ordinary skill in the art cannot translate the definition into meaningfully precise claim scope."). D. "which fragment comprises" Claim 1 states that the peptide fragment comprises an amino acid sequence derived from filaggrin. `724 Patent col.15 l.25-26. "The transitional term `comprising' . . . is inclusive or open-ended and does not exclude additional, unrecited elements or method steps." MPEP 2111.03. Under Federal Circuit law, "comprising" is a term of art meaning that "the named elements are essential, but other elements may be added and still form a construct within the scope of the claim." Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). It is well understood to mean "including but not limited to." CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007). Defendant's proposed construction for claim 1 states that the fragment "can include amino acids and amino acid sequences in addition to the amino acid sequence of filaggrin." (Doc. No. 105 at 4.) Plaintiff objects to this specific language, suggesting instead that the fragment "must contain what is expressly set forth in the claim, but can include additional elements." (Id.) The Court adopts Plaintiff's construction as it is based directly on the case law interpreting the meaning of "comprising." The parties agree that the fragment may contain elements in addition to an amino acid sequence derived from filaggrin, but the Court declines to elaborate on what additional elements are permissible. As discussed below, the extent to which a fragment may deviate from filaggrin and still fall within the claim is a question of fact for the jury. See PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354-55 (Fed. Cir. 1998) (holding that whether a substance had a composition "consisting essentially of" listed ingredients was not a matter of claim construction but an infringement issue for the jury). /// /// /// -708cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 E. "derived from said filaggrin by replacing at least one arginine residue in the amino acid sequence with a citrulline residue" Claim 1 states that the claimed fragment comprises an amino acid sequence derived from filaggrin by replacing at least one arginine with a citrulline. `724 Patent col.15 l.25-28. Plaintiff's construction provides for an amino acid sequence obtained from filaggrin and "changed by substituting at least one arginine residue in the filaggrin sequence with a citrulline residue." (Doc. No. 105 at 5.) Defendant's construction states that the amino acid sequence "includes an amino acid sequence of filaggrin (SEQ ID NO: 19) with changes including at least one arginine residue substituted by a citrulline residue." (Id.) Defendant's construction is more open-ended, while Plaintiff's implies that the only permissible change is the argininecitrulline substitution. The Court agrees with Defendant on this issue. The Court first notes that the use of the word "comprises" indicates that the fragment's composition is open-ended including but not limited to an amino acid sequence derived from filaggrin. CIAS, 504 F.3d at 1360. In addition to the language of the claim itself, the patent's specification is "the single best guide to the meaning of a disputed term." Vitronics, 90 F.3d at 1582. Here, the Patent's specification confirms Defendant's interpretation: To a person skilled in the art it will be apparent that there are a number of possible variations to the present invention as specified by the apended claims. For instance, the peptides mentioned on the formula sheet may also be part of other oligopeptides. They may be provided at one or both ends with one or more amino acids while also, two or more peptides according to the invention may be part of one oligopeptide. It is also possible to shorten the peptides by one or more amino acids, provided this does not have a significantly adverse effect on the reactivity. `724 Patent col.3 l.37-46. Thus, the specification expressly provides for modification of the amino acid sequence beyond citrullination. Plaintiff argues that the claim is limited by statement that the sequence is "derived from filaggrin." Plaintiff contends that "an amino acid sequence cannot be considered to be -808cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 `derived' from the parent sequence if it has been changed beyond recognition to something that cannot be recognized as having been originally obtained, actually or theoretically, from the parent sequence." (Pl.'s Br. at 20.) Plaintiff objects to the fact that Defendant's proposed construction places no limit on the extent of changes that may be made to filaggrin sequence. However, Defendant's construction is consistent with the patent language itself. Neither proposed construction specifies the scope of allowable changes. This is appropriate, as the extent to which a fragment may deviate from filaggrin and still fall within the claim is a question of fact for the jury. See PPG Indus., 156 F.3d at 1354-55 (holding that whether a substance had a composition "consisting essentially of" listed ingredients was not a matter of claim construction but an infringement issue for the jury). F. "specifically immunoreactive" Claim 1 states that the antigen is "specifically immunoreactive with anti-fillagrin antibodies present in the serum of subject suffering from rheumatoid arthritis." `724 Patent col.15 l. 29-31.) Plaintiff argues that the phrase "specifically immunoreactive" requires that the antigen recognize and bind to form complexes "only with anti-filaggrin antibodies present in the serum portion of the blood of individuals suffering from rheumatoid arthritis." 9Doc. No. 105 at 6.) Defendant's construction is less demanding, requiring only that the antigen "preferentially reacts with anti-filaggrin antibodies present in the serum portion of the blood of individuals suffering from rheumatoid arthritis." (Id.) The Court agrees with Defendant. A patent's specification is "always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quotation omitted). Here, the specification consistently uses the term "specifically" as a matter of degree, not an absolute. For example, it states that the claimed peptide is "suitable for diagnostic research with increased specificity." `724 Patent col.1 l.49-50. It explains that the use of a cyclic peptide enhances "specificity." col.6 l.14-17. It points out that a prior art test is "not very specific." col.1 l.65 - col.2 l.1. Finally, it states that the claimed invention is suitable for "high-specificity testing." col.2 l.54-55. In the context of binding specificity, the specification refers to an "organic compound comprising a -908cv845 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 part that is able to compete with a peptide of the invention for binding to an antibody which is specific for said peptide." `724 Patent col.3 l.4-7. Even though this antibody is "specific" for the peptide, the invention relates to another compound that also binds with the antibody. Thus, the specification describes specificity as something that can be increased and enhanced, something that varies from antigen to antigen. This treatment is inconsistent with Plaintiff's construction that specificity equals exclusivity. Under Federal Circuit law, "when a patentee uses a claim term throughout the entire patent specification, in a manner consistent with only a single meaning, he has defined that term by implication." Bell Atl. Network Servs., Inc. v. Covad Commc'ns Group, Inc., 262 F.3d 1258, 1271 (Fed. Cir. 2001). Conclusion The Court compliments the parties for their excellent presentations. IT IS SO ORDERED. DATED: August 24, 2009 ________________________________ MARILYN L. HUFF, District Judge UNITED STATES DISTRICT COURT - 10 - 08cv845 CLAIM 1 (language for which the parties submitted proposed construction in bold) An antigen consisting of a cyclic peptide which peptide is a fragment of the amino acid sequence of filaggrin (SEQ ID NO: 19) and which fragment comprises an amino acid sequence derived from said filaggrin by replacing at least one arginine residue in the filaggrin amino acid sequence, with a citrulline residue, which antigen is specifically immunoreactive with anti-filaggrin antibodies present in the serum of subjects suffering from rheumatoid arthritis. Claim Language "An antigen . . ." ". . . consisting of . . ." INOVA Diagnostics "substance to which antibodies bind" "consisting of" means that the claimed invention contains only what is expressly set forth in the claim and does not exclude additional components that are unrelated to the invention Euro-Diagnostica et al. "a molecule to which antibodies bind" "consisting of" means that the claimed invention contains only what is expressly set forth in the claim and does not exclude additional components that are unrelated to the invention Court's Construction a substance to which an antibody binds "consisting of" means that the claimed invention contains only what is expressly set forth in the claim and does not exclude additional components that are unrelated to the invention [The Court adopts the parties' stipulated construction.] one peptide, a sequence of amino acids, that includes one or more bonds forming one or more looped structures in the peptide ". . . a cyclic peptide . . ." "one peptide, a sequence of amino acids, that includes one or more covalent bonds that cause the peptide to form one or more looped structures" "a sequence of amino acids that includes one or more bonds forming one or more looped structures" - 11 - 08cv845 Claim Language ". . . a fragment of the amino acid sequence . . ." ". . . which fragment comprises . . ." INOVA Diagnostics the term "fragment" is indeifinite in the context of the claim, and as such cannot be construed "comprises" means that the claimed fragment must contain what is expressly set forth in the claim, but can include additional elements "a sequence of amino acids that is obtained from filaggrin and changed by substituting at least one arginine residue in the filaggrin sequence with a citrulline residue" "which antigen recognizes and binds to form complexes only with anti-filaggrin antibodies present in the serum portion of the blood of individuals suffering from rheumatoid arthritis" Euro-Diagnostica et al. "an incomplete part" Court's Construction an incomplete part "comprises" is open-ended, which means the fragment can include amino acids and amino acid sequences in addition to the amino acid sequence of filaggrin "the amino acid sequence includes an amino acid sequence of filaggrin (SEQ ID NO: 19) with changes including at least one arginine residue substituted by a citrulline residue" "the antigen preferentially reacts with anti-filaggrin antibodies present in the serum portion of the blood of individuals suffering from rheumatoid arthritis" The claimed fragment must contain what is expressly set forth in the claim, but can include additional elements. ". . . amino acid sequence derived from said filaggrin by replacing at least one arginine residue in the filaggrin amino acid sequence with a citrulline residue . . ." ". . . which antigen is specifically immunoreactive with antifilaggrin antibodies present in the serum of subjects suffering from rheumatoid arthritis . . ." a sequence of amino acids that is obtained from filaggrin with changes including at least one arginine residue substituted by a citrulline residue The antigen preferentially reacts with anti-filaggrin antibodies present in the serum portion of the blood of individuals suffering from rheumatoid arthritis. - 12 - 08cv845 CLAIM 2 (language for which the parties submitted proposed construction in bold) The antigen of claim 1 wherein one arginine is replaced by citrulline. Claim Language "The antigen of claim 1 . . ." ". . . wherein one arginine is replaced by citrulline." INOVA Diagnostics This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "wherein one arginine is substituted by one citrulline in the filaggrin sequence" Euro-Diagnostica et al. This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "wherein one arginine is substituted by one citrulline in the filaggrin sequence" Court's Construction This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "wherein one arginine is substituted by one citrulline in the filaggrin sequence" [The Court adopts the parties' stipulated construction.] - 13 - 08cv845 CLAIM 3 (language for which the parties submitted proposed construction in bold) The antigen of claim 1 wherein two or more arginines are replaced by citrulline. Claim Language "The antigen of claim 1 . . ." ". . . wherein two or more arginines are replaced by citrulline." INOVA Diagnostics This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "wherein two or more arginines are substituted by two or more citrullines in the filaggrin sequence" Euro-Diagnostica et al. This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "wherein two or more arginines are substituted by two or more citrullines in the filaggrin sequence" Court's Construction This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "wherein two or more arginines are substituted by two or more citrullines in the filaggrin sequence" [The Court adopts the parties' stipulated construction.] - 14 - 08cv845 CLAIM 4 (language for which the parties submitted proposed construction in bold) The antigen of claim 1 which contains at least two cysteines. Claim Language "The antigen of claim 1 . . ." ". . . which contains at least two cysteines." INOVA Diagnostics This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "the antigen has two or more cysteine amino acids" Euro-Diagnostica et al. This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "the antigen has two or more cysteine amino acids" Court's Construction This claim is dependent upon claim 1, thus incorporating all of the elements of claim 1. "the antigen has two or more cysteine amino acids" [The Court adopts the parties' stipulated construction.] - 15 - 08cv845 CLAIM 8 (language for which the parties submitted proposed construction in bold) A method to detect rheumatoid arthritis by detecting an autoimmune antibody in the serum of a subject, said method comprising: contacting the antigen of claim 1 with said serums, and detecting the presence or absence of a complex between the antigen and an antibody; wherein the presence of said complex detects rheumatoid arthritis. Claim Language ". . . said method comprising . . ." INOVA Diagnostics the accused method must contain every element of the claimed method, but can also include additional, unclaimed elements Euro-Diagnostica et al. the accused method must contain every element of the claimed method, but can also include additional, unclaimed elements Court's Construction the accused method must contain every element of the claimed method, but can also include additional, unclaimed elements [The Court adopts the parties' stipulated construction.] ". . . contacting . . ." "touching" "touching" "touching" [The Court adopts the parties' stipulated construction.] ". . . the antigen of claim 1 . . ." This claim incorporates all of the elements of claim 1. This claim incorporates all of the elements of claim 1. This claim incorporates all of the elements of claim 1. - 16 - 08cv845 Claim Language ". . . said serums . . ." INOVA Diagnostics "the serum of a subject" Euro-Diagnostica et al. "the serum of a subject" Court's Construction "the serum of a subject" [The Court adopts the parties' stipulated construction.] - 17 - 08cv845 CLAIM 9 (language for which the parties submitted proposed construction in bold) The method of claim 8 wherein the detecting comprises use of an antihuman antibody. Claim Language "The method of claim 8 . . ." ". . . the detecting . . ." INOVA Diagnostics This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. the "detecting" step of claim 8 Euro-Diagnostica et al. This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. the "detecting" step of claim 8 Court's Construction This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. the "detecting" step of claim 8 [The Court adopts the parties' stipulated construction.] ". . . comprises . . ." In order to infringe, the accused method must contain every element of the "detecting" claim limitation, but can also include additional unclaimed elements. In order to infringe, the accused method must contain every element of the "detecting" claim limitation, but can also include additional unclaimed elements. In order to infringe, the accused method must contain every element of the "detecting" claim limitation, but can also include additional unclaimed elements. [The Court adopts the parties' stipulated construction.] ". . . use of an antihuman antibody." "use of an antibody that binds to human antibodies" "use of an antibody that binds to human antibodies" "use of an antibody that binds to human antibodies" [The Court adopts the parties' stipulated construction.] CLAIM 10 - 18 08cv845 (language for which the parties submitted proposed construction in bold) The method of claim 8 wherein the detecting comprises use of an enzyme-linked immunosorbent assay (ELISA). Claim Language "The method of claim 8 . . ." ". . . the detecting . . ." INOVA Diagnostics This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. the "detecting" step of claim 8 Euro-Diagnostica et al. This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. the "detecting" step of claim 8 Court's Construction This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. the "detecting" step of claim 8 [The Court adopts the parties' stipulated construction.] ". . . comprises . . ." In order to infringe, the accused method must contain every element of the "detecting" claim limitation, but can also include additional unclaimed elements. In order to infringe, the accused method must contain every element of the "detecting" claim limitation, but can also include additional unclaimed elements. In order to infringe, the accused method must contain every element of the "detecting" claim limitation, but can also include additional unclaimed elements. [The Court adopts the parties' stipulated construction.] ". . . use of an enzymelinked immunosorbent assay (ELISA)." "use of a test that uses an enzyme, a protein that catalyzes a biochemical reaction, and an antibody or antigen linked thereto" "use of a test that uses an enzyme, a protein that catalyzes a biochemical reaction, and an antibody or antigen linked thereto" "use of a test that uses an enzyme, a protein that catalyzes a biochemical reaction, and an antibody or antigen linked thereto" [The Court adopts the parties' stipulated construction.] CLAIM 11 - 19 - 08cv845 (language for which the parties submitted proposed construction in bold) The method of claim 8 wherein the antigen contains at least two cysteines. Claim Language "The method of claim 8 . . ." ". . . wherein the antigen contains at least two cysteines . " INOVA Diagnostics This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. "the antigen has two or more cysteine amino acids" Euro-Diagnostica et al. This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. "the antigen has two or more cysteine amino acids" Court's Construction This claim is dependent upon claim 8, thus incorporating all of the elements claimed in claim 8. "the antigen has two or more cysteine amino acids" [The Court adopts the parties' stipulated construction.] - 20 - 08cv845

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