Saturday, August 24, 2013

The meaning of "i.e." discussed by CAFC in SkinMedica

SkinMedica v Histogen

SkinMedica, Inc. (“SkinMedica”) appeals from the decision of the United States District Court for the Southern District of California granting Histogen, Inc., Histogen Aesthetics, and Gail Naughton (collectively “Histogen”) summary judgment of noninfringement of the asserted claims of U.S. Patent Nos. 6,372,494 (’494 patent) and 7,118,746 (’746 patent) after construing a phrase common to both patents. Because we find no legal error in the district court’s construction, we affirm the grant of summary judgment.

Of background

In May 2011, the United States District Court for the Southern District of California construed the phrase “culturing . . . cells in three-dimensions” as “growing . . . cells in three dimensions (excluding growing in monolay- ers or on microcarrier beads).”5 J.A. 49. The court reasoned that “the inventors acted as their own lexicographers, defining ‘culturing . . . cells in three- dimensions’ away from its ordinary meaning,” by consist- ently distinguishing beads from three-dimensional cultures in the specification. J.A. 21. That conclusion was evident from the written description, according to the court, because the inventors used the disjunctive “or” and the disjunctive phrase “as opposed to” as coordinating conjunctions when they listed monolayer, beads, and three-dimensions as the methods used in the invention to culture cells. Id. The court noted that there was only one other reference to culturing with beads in the specifica- tion: a statement by the inventors that the conditioned medium created from bead cultures was “conventional” and “usually discarded.” Id. The court also concluded that the patentees “explicitly defined beads as a two- dimensional culture method” by using the phrase “beads (i.e. two-dimensions).” J.A. 22.

At district court:

Following claim construction, Histogen moved for summary judgment on the infringement claims. Based on its construction of the phrase “culturing . . . cells in three- dimensions,” the district court granted Histogen’s motion in November 2011. In its summary judgment opinion, the court first dismissed an argument by SkinMedica in opposition to the summary judgment motion that the phrase “excluding grown . . . on microcarrier beads” only excluded “two-dimensional growth on beads,” not three- dimensional growth “using” beads. J.A. 53 (emphases added). The court clarified that its “use of the preposition ‘on’ as opposed to the preposition ‘between’ or the gerund ‘using’” was “nothing more than the Court’s dictional preference” and that its definition of “culturing cells in three-dimensions” would also exclude three-dimensional growth using beads. J.A. 52. After that explanation, the court determined there was no genuine dispute that Histogen’s culturing method begins as “one- or two- dimensional growth” on beads that then “evolves into a three-dimensional growth phase in which the cells crawl off the beads.” J.A. 54. The court held that summary judgment of noninfringement was appropriate because “Histogen’s cell growth process, which uses beads, cannot infringe the disputed claim element as construed.” J.A. 56.

The issue before the CAFC was simple:

SkinMedica raises a single point of error on appeal. It argues that the district court erroneously excluded beads from the definition of “culturing . . . cells in three- dimensions.”


We find no basis to disturb the district court’s construction of the phrase “culturing . . . cells in three- dimensions.” The specification clearly proves that the patentees defined the three-dimensional culturing re- quired by the claims to exclude culturing with beads, because the patent expressly confines culturing with beads to two-dimensional culturing. Whether viewed as a matter of disclaimer or of lexicography, the result is the same: the kind of three-dimensional culturing protected by the patent excludes use of beads. Because the accused method employs beads, it cannot infringe the patents in suit. We therefore affirm the district court’s grant of summary judgment of noninfringement to Histogen.
During claim construction, terms are not always af- forded their ordinary meaning. In this case, the ordinary meaning of “culturing . . . cells in three-dimensions” would reach the use of beads. The question is whether the patentees here instead defined “culturing . . . cells in three-dimensions” to exclude the use of beads. If the specification reveals “a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess[,] . . . the inventor’s lexicography governs.” Id. at 1316; see Helmsderfer v. Bobrick Wash- room Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008) (explaining that inventors’ definition of a claim term controls when they “clearly express an intent” to redefine a term used in the claims). And if the specification re- veals “an intentional disclaimer, or disavowal, of claim scope by the inventor,” the scope of the claim, “as ex- pressed in the specification, is regarded as dispositive.” Phillips, 415 F.3d at 1316 (citing SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1343– 44 (Fed. Cir. 2001)).
Disclaiming the ordinary meaning of a claim term— and thus, in effect, redefining it—can be affected through “repeated and definitive remarks in the written descrip- tion.” Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374 (Fed. Cir. 2008) (citing Watts v. XL Sys., 232 F.3d 877, 882 (Fed. Cir. 2000)); see SafeTCare Mfg., Inc. v. Tele-Made, Inc., 497 F.3d 1262, 1270 (Fed. Cir. 2007) (finding disclaimer of “pulling force” where “the written description repeatedly emphasized that the motor of the patented invention applied a pushing force”); SciMed, 242 F.3d at 1344 (“[T]he written description can provide guidance as to the meaning of the claims, thereby dictating the manner in which the claims are to be con- strued, even if the guidance is not provided in explicit definitional format.”);
In a specification, a patentee’s “use of ‘i.e.’ signals an intent to define the word to which it refers.” Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1334 (Fed. Cir. 2009); see also Abbott Labs. v. Novopharm Ltd., 323 F.3d 1324, 1330 (Fed. Cir. 2003) (holding that a patentee “explicitly de- fined” a term by using “i.e.” followed by an explanatory phrase). The inventors also used the phrase “i.e.” else- where in the specification (twelve other times in total) to introduce an explanation or definition of a word or phrase. See ’494 patent col. 1 l. 7; col. 7 l. 44; col. 8 l. 65; col. 10 l. 1;col.15l.16;col.18l.52;col.19l.20;col.20l.16; col. 22l.40;col.26l.15;col.27l.36;col.30l.58. Basedon the plain meaning of the term “i.e.” and the patentees’ consistent use of it throughout the specification, there is no reason to believe that the inventors did not intend for the abbreviation to signal an intent to define the word it followed when they stated “[t]he cells are cultured in . . .beads (i.e., two-dimensions) or, preferably, in three- dimensions.”
SkinMedica, however, argues that the inventors did not explicitly define beads as a two-dimensional culture method. It asserts that our cases indicate that the “mere use of ‘i.e.’ does not act as an express definition or limita- tion” and “must be read in the context of the patent as a whole.” Appellant’s Br. 41. Read in context, SkinMedica believes that the phrase “beads (i.e., two-dimensions)” merely represents the inventors’ recognition of the ability to use beads in both two- and three-dimensional cultures.(...)
In addition, the import we assign to the term “i.e.” here aligns with our case law. We have held—as dis- cussed above—that a “specification’s use of ‘i.e.’ signals an intent to define the word to which it refers.” Edwards Lifesciences, 582 F.3d at 1334. As SkinMedica correctly points out, such use of “i.e.” is not absolute. It identifies several cases in which we did not give “i.e.” its plain meaning and import. But the reasoning of those cases does not apply here. (...)
Thus, we give the term “i.e.” here its plain meaning— that it “signals an intent to define the word to which it refers.” Edwards Lifesciences, 582 F.3d at 1334. That reading comports with the inventors’ other uses of the abbreviation in the specification and with each and every other reference to culturing with beads. We therefore conclude that the patentees expressly defined culturing in beads as a two-dimensional culturing method. Because it is defined as two-dimensional, culturing in beads cannot be the three-dimensional culturing required by the claims.

Chief Judge Rader dissented:

There is a “heavy presumption” in favor of the ordinary meaning of claim language. Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). To overcome this presumption, the patentee must “clearly set forth” and “clearly redefine” a claim term away from its ordinary meaning. Id. The disavowal must be “unmistakable” and “unambiguous.” Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1322 (Fed. Cir. 2013). This standard is “exacting.” Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012). In my judgment, the patentees did not disavow the ordinary meaning of “culturing...cells in three-dimensions” to exclude the use of beads. Therefore, I respectfully dissent.

Of conclusory affirmations:

The court recognizes this, but refuses to give Dr. Salomon’s testimony any weight because it “consists exclu- sively of three conclusory affirmations elicited by leading questions posed by SkinMedica’s counsel. His testimony lacks any convincing detail explaining why or how cells in bead cultures exhibit the characteristics of whole tissue in vivo he claims they possess.” Majority Op. at 39–40. To my eyes, Dr. Salomon’s testimony, when viewed as a whole, deserves great weight and respect.(....)

As to the leading nature of the questions posed by SkinMedica’s counsel, Histogen did not object. Any defect as to the form of those questions has been waived. Fed. R. Civ. P. 32(d)(3)(B).

Of the use of i.e.,

The abbreviation “i.e.” is commonly used as a qualifi- er, meaning “that is to say” or “in other words.” That is consistent with how the patentees used “i.e.” in other parts of the specification. Contra Majority Op. at 22; see, e.g., ’494 patent col. 15 ll. 15–19. It is reasonable to view the “i.e.” in this case as merely clarifying that the refer- ence to beads is in the context of two-dimensions. The ambiguity is readily apparent.


In sum, to my eyes, the four references to beads relied on by this court are ambiguous. They do not meet the exacting standard imposed by this court’s precedent. Because I would find that the patentees did not unmis- takably and unambiguously disavow the ordinary mean- ing of “culturing . . . cells in three-dimensions” to exclude the use of beads, I would reverse the district court’s grant of summary judgment.


Post a Comment

<< Home