The opinion of the court was delivered by: Marilyn L. Huff, District Judge United States District Court
ORDER FOR UNITED STATES CLAIM CONSTRUCTION PATENT NUMBER 7,335,724
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.
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.
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.
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) ("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.
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.*fn1 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 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.
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.
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).
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." ...