Citations
- 648 F. Supp. 2d 1294
Full opinion text
FINDINGS OF FACT AND CONCLUSIONS OF LAW
TIMOTHY J. CORRIGAN, District Judge.
This consolidated case pertains to various CIBA Vision Corporation (“CIBA”) patents for extended wear contact lenses. This dispute started with a declaratory-judgment action brought by Johnson & Johnson Vision Care, Inc. (“J & J”) against CIBA, seeking a declaration that five of CIBA’S United States Patents, U.S. Patent Nos. 5,760,100 (“'100 Patent”), 5,776,999 (“'999 Patent”), 5,789,461 (“'461 Patent”), 5,849,811 (“'811 Patent”) and 5,965,631 (“'631 Patent”) (“Nicolson patents”) are invalid and/or unenforceable, and alternatively that J & J’s new silicone hydrogel contact lenses, the Phoenix contact lens, marketed under the name ACUVUE®OASYStm (“Acuvue Oasys” or “Oasys”), does not infringe upon the CIBA patents. (Case No. 3:05-ev-135-J-32TEM, Doc. 1.) CIBA answered and counterclaimed that J & J’s lens infringes upon the '100, '461, '811, and '631 CIBA Patents. In case No: 3:06-cv-301-J-32TEM, CIBA as plaintiff filed an action alleging that J & J has and continues to infringe upon CIBA’s United States Patent No. 6,951,894 (“'894 Patent”), also a Nicolson patent. J & J counterclaimed, seeking a declaration that the '894 Patent is invalid and unenforceable.
On March 14, 2008, this Court issued its Corrected Markman Order construing terms found in one or more of all six patents at issue. (Doc. 121); Johnson & Johnson Vision Care, Inc. v. CIBA Vision Corp., 540 F.Supp.2d 1233 (M.D.Fla.2008). The ease was subsequently trimmed to 31 asserted claims from five of the six patents in suit, with CIBA alleging infringement of the 31 claims (Docs. 189, 190 at 9; 191). Following extensive briefing and submission of evidentiary material and argument, the Court, on December 3, 2008, entered an Order denying J & J’s motion for summary judgment as to noninfringement and invalidity, and denying CIBA’s motion as to infringement and in part as to invalidity. (Doc. 190.) The Court granted CIBA’s motion for summary judgment pertaining to J & J’s invalidity defense/claim based on anticipation by prior art (with one exception), and “best mode.” (Doc. 190 at 55-56.)
The Court conducted a ten day bench trial from March 30 through April 10, 2009 (Docs. 269-78), and heard closing arguments on June 10, 2009, the record of which is incorporated here. (Docs. 310, 311.) At trial, CIBA asserted as infringed nine claims in three patents which CIBA owns (Docs. 257; 287 at 6-11): claims 1, 28 and 56 of the '100 Patent; claims 28 and 29 of the '811 Patent; and claims 89, 90, 96 and 99 of the '894 Patent. Having stipulated to the issues to be decided (Doc. 281), the parties submitted post-trial proposed findings of fact and conclusions of law (Docs. 286, 287) and responses. (Docs. 303, 305.) The Court has exhaustively reviewed the extensive record in this case, examined the evidence presented at trial, observed the witnesses, read the parties’ post-trial submissions, and considered the arguments. The Court now makes the following findings of fact and conclusions of law as required by Federal Rules of Civil Procedure 52(a).
I. Infringement
A. CIBA’s Infringement Contentions
CIBA asserts a total of nine claims from three of the patents in suit. ('100 Patent els. 1, 28, and 56; '811 Patent els. 28 and 29; '894 Patent els. 89, 90, 96 and 99.) The asserted claims relate to silicone hydrogel contact lenses suitable for continuous periods of extended wear of “about” or “at least” 24 hours or “at least” seven days. The claims teach that the patented lens exhibits an oxygen permeability and/or transmissibility of at least or about 70 barrers; and threshold levels of ion permeability. Four claims require a “surface treatment process” while the other five asserted claims do not recite this limitation. The three claims asserted from the '100 Patent recite that the lens must have separate “phases,” while the remaining asserted claims do not.
CIBA contends that the evidence establishes that J & J’s Aeuvue Oasys product meets each and every limitation in the nine asserted claims. (Doc. 287 at 16-17; D. Dem. 2-9 (citing Tr. II at 54 (Harris), 110-14 (Pitt), 242 (Gido); Tr. Ill at 113-14, 126-28 (Hoffman), 201-07 (Mays)).)
J & J asserts that the Aeuvue Oasys does not meet four sets of claim limitations, based upon a(l) lack of “oxygen permeability,” “high oxygen permeability” and “oxygen transmissibility;” (2) lack of a “surface modified by a surface treatment process;” (3) lack of “polyvinylpyrrolidone at a surface of the lens;” and (4) lack of “phases.” (Doc. 281.) J & J does not dispute that Aeuvue Oasys meets each of the other limitations of the asserted claims. (Tr. II at 43-46; Tr. X at 123-24; Docs. 253, 281.)
The Court finds that CIBA has proved that Aeuvue Oasys meets all of the other limitations of the asserted claims (with the following exceptions as set forth in the footnote) and addresses J & J’s four non-infringement contentions below. In doing so, the Court observes that an infringement analysis involves two steps: (1) claim construction and (2) comparison of the properly construed claims to the accused device, here the Acuvue Oasys. Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365, 1372 (Fed.Cir.2006). The Court accomplished the first step in its Markman Order. (Doc. 121.)
“To establish infringement, every limitation set forth in a patent claim must be found in an accused product or process exactly or by a substantial equivalent.” Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535 (Fed.Cir.1991); see also Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263, 1273 (Fed.Cir.2004). “Literal infringement requires that each and every claim limitation be present in the accused device.” Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc., 467 F.3d 1370, 1378 (Fed.Cir.2006). Under the doctrine of equivalents, a claim limitation is equivalently present if there are only “insubstantial differences” between the limitation and the corresponding aspects of the device. CAE Screenplates, Inc. v. Heinrich Fiedler GmbH & Co. KG, 224 F.3d 1308, 1318-19 (Fed.Cir.2000). “A finding of infringement under the doctrine of equivalents requires a showing that the difference between the claimed invention and the accused product was insubstantial.” Crown Packaging Tech. v. Rexam Beverage Can Co., 559 F.3d 1308, 1312 (Fed.Cir.2009). CIBA, as patentee, has the burden of proving infringement by a preponderance of the evidence. Warner-Lambert Co. v. Teva Pharm. USA, Inc., 418 F.3d 1326, 1341 (Fed.Cir.2005).
B. J & J’s Non-Infringement Positions
1. Lack of “oxygen permeability,” “high oxygen permeability” and “oxygen transmissibility”
CIBA contends that J & J’s Acuvue Oasys lens satisfies the oxygen permeability and transmissibility limitations that are a part of all nine asserted CIBA patent claims, which set minimum values of permeability and transmissibility. Both of these properties relate to a lens’ ability to allow oxygen from the atmosphere to travel through the lens to the cornea of the eye to promote the health of the eye. (Tr. I at 61 (CIBA inventor Dr. Paul C. Nicolson (“Nicolson”)).) The dispute over the “oxygen permeability” and “oxygen transmissibility” terms centers upon whether the CIBA patent limitations teach that oxygen permeability (and oxygen transmissibility) values as measured by the single point coulometric method specified in the patents do not change with the thickness of the lens measured. J & J contends that the CIBA patents teach that the oxygen permeability (“Dk”) does not change with thickness and thus, because the evidence established that the Acuvue Oasys lens Dk values are dependent on thickness, the Acuvue Oasys does not infringe this limitation.
“Oxygen transmissibility” (“Dk/t”) is defined first in the patent as being:
The rate at which oxygen will pass through a specific ophthalmic lens. Oxygen transmissibility, Dk/t, is conventionally expressed in units of barrers/mm, where t is the average thickness of the material [in units of mm] over the area being measured ....
(TOO Patent col. 4 11. 51-56.) In seeking a Markman construction of the term, CIBA had pressed for a definition which specified that oxygen permeability “Dk”, as used in the oxygen transmissibility formula Dk/t, referred to “the oxygen permeability of the lens measured by the coulometric method disclosed in the CIBA patents ... without any corrections.” (See Docs. 121 at 84; 86 at 16-17.) J & J offered no alternative construction, contending that the term was “indefinite” as it related to the definition of “barrer.” (Docs. 94 at 33; 121 at 84-86.) Concluding that the measurement technique of oxygen permeability (“Dk”) and oxygen transmissibility (“Dk/t”) need not be resolved at the claim construction phase of the proceedings, (Doc. 121 at 86), the Court adopted CIBA’s claim term construction, without reference to the coulometric method, relied upon the patent’s definition, and construed “oxygen transmissibility” to mean:
The rate at which oxygen will pass through a specific ophthalmic lens denoted as Dk/t, where t is the average thickness of the material [in units of mm] over the area being measured and Dk is the oxygen permeability of the lens.
(Id. at 87.)
Appearing immediately following the patent’s definition of “oxygen transmissibility” is the patent’s definition of the term “oxygen permeability”:
The “oxygen permeability”, Dk, of a lens material does not depend on lens thickness. Oxygen permeability is the rate at which oxygen will pass through a material. Oxygen permeability is conventionally expressed in units of “barrers”....
('100 Patent col. 4 11. 58-61.) In seeking construction of the term “oxygen permeability,” CIBA first urged that the term be construed as “the rate at which oxygen will pass through a material” (Doc. 86 at 14) and later revised its argument urging that “[o]xygen permeability is measured in accordance with the coulometric method described in the CIBA patents, without any corrections, and can vary with thickness.” (Docs. 91-2 at 3; 121 at 71.) CIBA argued that “the actual measurement technique taught in the patents does depend on thickness because a liquid boundary layer is present [on the contact lens] and no regression analysis [which is performed to correct for the effect caused by a layer of slow moving or non-moving water boundary layer that is immediately adjacent to the lenses] is taught.” (Doc. 121 at 72.) J & J proposed that “oxygen permeability” be defined as “the rate at which oxygen passes through a material, which does not depend on lens thickness,” (Docs. 94 at 31; 121 at 71), saying “that ‘[o]xygen permeability is a physical property of the material ... [that] is not a function of the shape or thickness of the material sample.’ ” (Doc. 121 at 73 (citing Doc. 84-97 (J & J Ex. 92 at 1)).) The Court adopted the patent’s specification which expressly defined “oxygen permeability,” declining to graft the patent’s specified measurement technique onto the definition of “oxygen permeability,” noting that defining “oxygen permeability” as independent of thickness “ ‘is true mathematically,’ and is to be distinguished from ‘the actual measurement technique taught in the patents [which] does depend on thickness because a boundary layer is present and no regression analysis is taught.’ ” (Doc. 121 at 74 (quoting CIBA argument Doe. 91 at 21).) The Court construed the term as follows:
The “oxygen permeability”, Dk, of a lens material does not depend on lens thickness. Oxygen permeability is the rate at which oxygen will pass through a material.
(Id. at 74.)
Both CIBA and J & J agree that the CIBA patents teach that the uncorrected single point coulometric method of measurement is to be used to determine oxygen permeability and transmissibility. (Docs. 286 at 11; 287 at 17.) The patent further describes the coulometric method of measurement as the “ ‘Wet’ measurement of oxygen permeability” as distinguished from the “dry measurement” or a “straight Dk value” which are “usually values determined on dry material.” The patent specifications note that the so-called wet and dry measurements differ greatly. ('100 Patent col. 51 11. 19-50; DTX 1448 ¶ 78 (CIBA inventor Dr. Lynn Cook Winterton (“Winterton”) Decl. on Re-examination).) “The coulometric method was chosen because unlike other methods, such as a polarographic method, the coulometric method can accurately measure permeabilities above 70 barrers (Dk units).” (DTX 1448 ¶ 78 (Winterton Decl. on Re-examination).)
CIBA acknowledges that the oxygen permeability values of high Dk materials as measured by the uncorrected single point coulometric method, will vary with thickness (i.e. different powers of contact lenses). (Tr. I at 170, 172 (Winterton); Tr. II at 96 (CIBA expert Dr. William George Pitt (“Pitt”)).) This is because the boundary layer of water that remains on the lens when measuring Dk using the single point coulometric method creates more resistance to the transport of oxygen molecules than the high Dk polymer lens material; the oxygen molecule meets resistance and has relatively low permeation through the water boundary layer, and then passes through the highly permeable contact lens at a higher rate. (Tr. II at 96 (Pitt); see also Tr. I at 169 (Winterton).) The effect of the boundary layer becomes more pronounced when the Dk of the material becomes much greater than that of water, which has a Dk of about 80 to 88— “[s]o as you go above that value, water becomes a great constraint.” (Tr. II at 37-38 (Winterton).) The water layer has a constant thickness; it’s the lens polymer thickness that is changing. The resulting measurement is the uncorrected single point coulometric value of Dk. (Tr. II at 94-97 (Pitt) D. Dem. 47.)
That presence of the water layer makes it appear that the Dk is changing as the thickness of that polymer changes. The intrinsic Dk is the same all the time. But our measurement gives us a value that appears to change. It [uncorrected value] actually does change. But that’s because we are measuring a single-pont Dk instead of the intrinsic Dk [of the lens].
(Tr. II at 100 (Pitt).) “[T]he intrinsic permeability ... does not depend on thickness.” (Id. at 104.) Further, the single-point uncorrected Dk will always be less than the intrinsic Dk values because of the contribution from the boundary layer. (Id. at 105.) While the single-point coulometric values of Dk vary with thickness of the lens, the intrinsic value of Dk — which is the rate at which oxygen travels through the lens material-does not vary with the thickness of the lens. (Id. at 100-01, 181-82; Tr. V. at 96 (J & J expert Dr. William Joseph Benjamin (“Benjamin”)).) According to CIBA, the definition of “oxygen permeability” in the patent, and as construed by the Court, represents “a mathematical statement” as opposed to the measured value of Dk. (Tr. II at 42 (Winterton).)
Using the single point coulometric method of measurement, CIBA’s test data on the Acuvue Oasys shows that the Dk (and Dk/t) of the Oasys varies with thickness, with Dk of 69.8 to 119.7 barrers and Dk/t from 66.2 to 114.7 barrers depending on thickness for the 8.4 base curve lens, and Dk of 73 to 120 barrers and Dk/t of 80 to 115 barrers depending on thickness for the 8.8 base curve Acuvue Oasys lens. (Tr. II at 57-60, 66 (CIBA employee Larry A. Alvord (“Alvord”)), 157-58 (Pitt); Tr. V at 24-26 (Benjamin); DTX 1138, 1042 at 1 (Dk for 8.4 base curve lens ranged between 67.8 and 124.5 barrers); D Dem. 11, 14; Doc. 286 at 12.) As the thickness of the Oasys lens increased from 60 to 180 microns, the oxygen permeability values increased from less than 70 to nearly 125 barrers. (Tr. V at 25-26 (Benjamin); PTX 29A.) While “the values that we measured for oxygen permeability did vary with the thickness of the lens,” CIBA’s test also showed that the “permeability of the material was uniform throughout the thickness of the lens.” (Tr. II at 78-79 (Alvord).) In CIBA expert Pitt’s opinion, the powers of the Acuvue Oasys lenses meet the oxygen permeability and transmissibility terms and high oxygen permeability terms set out in the CIBA patents, with the exception of several designated powers (thicknesses) of Oasys lenses. (Id. at 182-83; D. Dem. 17; see Doc. 287 at 25-26, 80.) J & J’s expert agrees that J & J’s Acuvue Oasys “has high oxygen permeability.” (Tr. VIII at 66 (J & J expert Dr. Paul L. Valint (“Valint”)); see also Tr. V at 65 (Benjamin) (“people in the field would say that it [Acuvue Oasys] has an oxygen permeability that’s up there”); Id. at 60-61 (intrinsic Dk of most Acuvue Oasys lenses fall into the “hyper-transmissible” category as do the CIBA contact lenses.))
According to J & J, the CIBA patent, as construed by the Court, teaches that measuring different thicknesses of the same lens material, using the single point coulometric method would result in the same Dk. (Doc. 286 at 11-12.) Because the Dk value of the Acuvue Oasys varies with thickness when measured by the single point coulometric method, the Oasys does not satisfy the CIBA claim terms. (Tr. V at 23, 37 (Benjamin).) “Only lenses having this property, independence of thickness, are within CIBA’s claims,” argues J & J. (Doc. 286 at 12.) Further, J & J argues that CIBA has not presented any evidence that the Acuvue Oasys lenses have the oxygen transmissibility required by the CIBA patents because of the flaw in its thickness-independent Dk limitation. (Id. at 12.)
J & J contends that a 1987 article published by CIBA inventor Winterton and others entitled “Coulometric Method for Measuring Oxygen Flux and Dk of Contact Lenses and Lens Materials” (PTX 208) supports J & J’s argument that the CIBA patents require that Dk not change with the thickness of the lens. J & J relies on Figure 4 in the 1987 article (id. at VI11928), which is a graph illustrating Dk versus thickness of the Monocurve Modified Tefilcon (38% Water) lens (average Dk 7), that shows an ever so slight decrease (“asymptotic curve”) in Dk as thickness increases, for the proposition that CIBA inventor Winterton, and by extrapolation the CIBA patents, require that Dk values do not “depend on” or vary with the thickness of the lens. (Tr. V at 54-56, 67, 104 (Benjamin); Doc. 286 at 14-15; Doc 303 at 11.) J & J also cites to a higher Dk material (Dk 63.7) referred to in Table I of the article (PTX 208 at V111926), which J & J says proves that CIBA inventor Winterton advocates that Dk does not change with the thickness of the lens even for higher Dk materials. (Doc. 303 at 11.) J & J cites to the article’s conclusion, specifically that “ ‘this technique ... has been shown to be ... thickness independent (for Dk).’ ” (Doc. 286 at 14 (quoting in part PTX 208 at V111931).)
“The oxygen permeability is typically, in science, referred to as ... a material property that is independent of the thickness. The transmissibility tells you how much flux, or the Dk divided by thickness or the t.... [Fjlux is analogous to transmissibility” (a “near cousin” to transmissibility). (Tr. I at 175 (Winterton).) The “intrinsic value” of oxygen permeability does not depend on the shape or character of the material itself. (Tr. I at 197 (Winterton).) According to CIBA inventor Winterton, the '100 Patent’s definition of “oxygen permeability” “flowed from a descriptor of transmissibility ... [a]nd they were trying to delineate the difference in context between transmissibility and the Dk that would later be used” to help the reader differentiate between transmissibility which does depend on thickness, and permeability. (Id. at 197-98.) J & J’s expert Benjamin defines oxygen permeability consistently: “[i]t’s an intrinsic property of the lens material. And it doesn’t depend upon the lens thickness or the shape of the lens or the design of the lens. The material has an oxygen permeability.... [Ijt’s ... the rate at which oxygen will pass through the material under the standard conditions of the test.” (Tr. V. at 24 (Benjamin).) Oxygen permeability, mathematically, does not have any dependency on thickness. (Tr. II at 189 (Pitt).)
Here, the parties do not dispute that the oxygen permeability of the Acuvue Oasys lens, when measured at various thicknesses, meets the oxygen permeability (and transmissibility) limitation values of the CIBA patents, with the exception of those few powers listed by CIBA. (Doc. 287 at 25-26, 80.) J & J contends, however, that because the oxygen permeability of the Oasys varies with its thickness, it does not infringe. J & J seeks further construction of the term “oxygen permeability” to include a limitation that the Dk value of a highly permeable silicone hydro-gel contact lens as measured by the single point coulometrie method, does not vary with or depend on the thickness of the lens. The flaw in this argument is that nowhere in the patent, the patent specifications, prosecution history, or the state of the art in 1995, does it say that the value of the oxygen permeability of an extended wear silicone hydrogel lens, when measured by the single point coulometrie method, may not vary with thickness. Rather, the '100 Patent defines “oxygen permeability” in its ordinary and mathematical meaning, and further specifies that oxygen permeability is to be measured using the single point coulometrie method. The patent’s mathematical definition of “oxygen permeability” in no way limits or dictates the results of the coulometrie measurements or resultant values.
J & J’s argument conflates the mathematical definition of “oxygen permeability” of “a lens material” which does not vary with thickness, with the methodology for measuring oxygen permeability by the uncorrected single point coulometric method, which, for highly permeable lenses, does vary with thickness. J & J concedes that the intrinsic Dk of a contact lens does not vary with the thickness of that lens. That is how the patent defines oxygen permeability. “[T]he words of a claim ‘are generally given their ordinary and customary meaning.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (citation omitted). Further, “the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips, 415 F.3d at 1313.
J & J’s reliance on the 1987 Winterton article for the proposition that the CIBA patents teach that Dk does not vary with thickness is misplaced. The article demonstrated that the coulometric method was reproducible and provided an alternative means of permeability measurement. (Tr. II at 127-29 (Pitt); PTX 208 at V111923.) The article stated that
boundary layer contributions were found to be insignificant for relevant thicknesses; as predicted by Fick’s law. Measurement of commercially available hydrogels reinforces the observation that water content most commonly determines the oxygen transmission of the material.
(PTX 208 at V111923.) The article did not discuss the measurement of oxygen permeability in highly permeable silicone hydro-gel lenses. (See id. at V111925 (“[mjaterials were generally commercially purchased hydrogel and RGP [rigid gas permeable] lenses”).) Further, the higher permeability (Dk 63) material measured at one thickness in Table 1 was not the subject of the Table 4 graph upon which J & J relies, (Tr. V at 106 (Benjamin)), but rather, Table 1 reports a film material measured over at least six days, as an “example of good oxygen transmitting material! ],” that illustrates “the high day-to-day reproducibility of the Dk and oxygen flux” with a low standard deviation. (PTX 208 at V111926.) The authors concluded, in full, that
“From the data given, this technique [coulometric method] of measuring oxygen flux, and resultant Dk’s, has been shown to be extremely reproducible, thickness independent (for Dk), and fits the boundary layer predictions of Fick’s law. That is to say, as the thickness of the sample increases, the contribution of the boundary layer becomes insignificant.”
(Id. at V111931.)
Figure 4 of the article (id. at V111928), relied on by J & J, shows a very slightly decreasing Dk on a lens material with a very low Dk of 7 barrers. Like the football player running at a low rate of speed through a muddy end zone and then onto the field, the boundary effect on a low Dk material is very small, and sometimes does not even show up in the data. (Tr. II at 186 (Pitt).) By contrast, the boundary effect on a high Dk lens (analogous to the speedy football player being slowed by the mud) has a much greater impact on the value of oxygen permeability as measured by the single point coulometric method. CIBA measured the Acuvue Oasys lens using the single point coulometric method and determined that Oasys met the Dk and Dk/t limitations of the asserted claims at nearly all thicknesses.
The Court finds that one of ordinary skill in the art would know that the single point coulometric measure of a highly oxygen permeable lens would vary with thickness because of the boundary effect. The patent, and to a certain extent Winter-ton’sl987 article, inform this result. The patent simply defines oxygen permeability in its mathematical terms (“Dk, of a lens material does not depend on thickness”). However, this definition is not determinate of the oxygen permeability measurement results of a high Dk lens using the single point coulometric method.
J & J’s interpretation of the patent would render the patent impossible and inoperable, because the single point oxygen permeability values of silicone hydrogel lenses with high oxygen permeability, as required by the CIBA patents, including CIBA’s own commercial embodiment Focus Night & Day, will always vary with the thickness of the lens. (See Tr. V at 33, 68-70 (Benjamin).) In other words, no high oxygen permeability silicone hydrogel lens would ever infringe upon the limitations of the CIBA patents, according to J & J. An interpretation excluding a preferred embodiment “is rarely, if ever, correct and would require highly persuasive evidentiary support.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583-84 (Fed.Cir.1996); see also Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1383 (Fed.Cir.2008) (“case law generally counsels against interpreting a claim term in a way that excludes the preferred embodiment from the scope of the invention.”).
The patent’s definition of “oxygen permeability” ('100 Patent col. 4 11. 58-63) and the Court’s construction of “oxygen permeability” which did not include a reference to the single point coulometric method, (Doc. 121 at 74), is not determinative of infringement. It is merely a definition of oxygen permeability, understood by those skilled in the art in 1995. The Court’s construction of the term “high oxygen permeability,” which includes that it be “measured in accordance with the coulometric method described in the CIBA patent” {id. at 78), as well as all of the asserted claims, which refer to “high oxygen permeability,” or specific oxygen permeability or transmissibility values, as measured by the coulometric method, all refer to the “apparent” Dk, which, as established by the patents, the prosecution history, and the evidence in this record, varies with thickness. CIBA has proven by the preponderance of the evidence that J & J’s Acuvue Oasys lens infringes upon the “oxygen permeability,” “high oxygen permeability” and “oxygen transmissibility” limitations of all asserted claims (with the exception of those few powers acknowledged by CIBA).
2. Lack of “surface modified by a surface treatment process”
J & J argues that CIBA has failed to prove by the preponderance of the evidence that the Acuvue Oasys lens meets the limitation “a surface modified by a surface treatment process” found in claims 1 and 28 of the '100 Patent and claims 28 and 29 of the '811 Patent, because the Oasys is a “monolith” with no separate surface treatment process.
The Court construed the claim term “surface treatment process” as follows:
“Surface treatment process” is a process (or processes) to render a surface more ophthalmically compatible, in which, by means of contact with a vapor or liquid, and/or by means of application of an energy source (1) a coating is applied to the surface of an article, (2) chemical species are adsorbed onto the surface of an article, (3) the chemical nature (e.g. electrostatic charge) of chemical groups on the surface of an article are altered, or (4) the surface properties of an article are otherwise modified.
(Doc. 121 at 23.) This construction is the verbatim definition of “surface treatment process” lifted from the '100 Patent’s specifications. (See '100 Patent col. 42 11. 44-52.) The parties do not dispute that the Acuvue Oasys does not meet the first three enumerated types of “surface treatment process,” and that the fourth category, “(4) the surface properties of an article are otherwise modified” is at issue here.
The Markman Order noted that the patent specifications describe “a variety of methods disclosed in the art for rendering a surface of a material hydrophilic,” including coating or grafting onto a lens a hydrophilic polymeric material by using a “number of processes.” “Another set of methods of altering the surface properties of a lens involves treatment prior to polymerization to form the lens,” including treating a lens mold with an energy source “causing the prepolymerization mixture immediately adjacent to the mold surface to differ in composition from the core of the prepolymerization mixture.” (Doc. 121 at 21 (quoting '100 Patent col. 42 11. 53-67 to col. 43 11.1-3).)
CIBA expert Dr. Allen S. Hoffman (“Hoffman”) testified that in his opinion, the Acuvue Oasys meets the claim term “surface modified by a surface treatment process” because of the addition of PVP [polyvinylpyrrolidone], which is a wetting agent, to the lens formula, which is then subjected to an energy source. (Tr. Ill at 74, 189-90 (Hoffman).) Hoffman testified that the PVP component in the Oasys lens is referred to as the additive “Hydra-Clear Plus” in the J & J advertisements of its product and on its internet website, which “show that if you put a drop of water on the surface of the lens it will spread over that surface, which is a very wettable surface.... very good evidence of the fact that there is a wettable surface on that lens.... They essentially say the additive makes the surface more wettable and moist.” (Tr. Ill at 76-77 (Hoffman); see also Tr. VII at 199 (Valint) (Hydra-Clear Plus refers to PVP that’s immeshed in the lens).) The addition of PVP to the Acuvue Oasys lens is the first step toward rendering the surface more ophthalmically compatible, according to CIBA.
Critical to understanding whether the Acuvue Oasys meets the “surface modified by a surface treatment process” claim term is an overview of the Oasys manufacturing process. First the ingredients that form the lens are mixed together in a liquid prepolymerization mixture, which involves mixing hydrophillic “HEMA” (6%), “DMA” (24%) and “PVP K90” (or “PVP”) (7%) with hydrophobic silicone compounds “SiGMA” (or “SÍMAA2” or “SiMAA”) (28%) and “mPDMS” (31%) with a solvent to disperse them and make them compatible with one another. The PVP K90 used in the Acuvue Oasys lens is a very hydrophilic (“water loving”) water soluble large molecule, with a high molecular weight of 360,000. It comprises 7% (by-weight) of the Acuvue Oasys lens. (Doc. 235-8 at 3 (stipulated list of ingredients).) The PVP is introduced into the prepolymerization mixture, and SÍMAA2 serves as a small compatibilizing molecule. (Tr. IV at 27-28, 52, 66-68 (J & J scientist Dr. David Carl Turner (“Turner”)); Tr. VII at 182— 85,192 (Valint).)
The mixture is then placed into plastic hydrophobic molds and irradiated with visible light, or “cured” by the application of an energy source. (Tr. VII at 211 (Valint); Tr. VIII at 66 (Valint); Tr. Ill at 190 (Hoffman).) The light reacts chemically and starts the polymerization process, during which the individual monomer materials knit together into long chains called polymers. (Tr. IV at 29-30,112 (Turner).) The mixture is “cured” by a “light-activated” curing process for 240 seconds, (plus a 30 second pre-cure) creating a network by crosslinking chains to form a mesh that entraps the long PVP molecules in it. (Tr. IV at 31, 78, 79 (Turner); Tr. Ill at 140 (Hoffman).) The PVP molecule is not “reactive,” but rather is a large homopolymer that is entangled in a network formed by the other reactive ingredients during the cure or polymerization process. (Tr. Ill at 78 (Hoffman); Tr. VIII at 81 (Valint).) Once the lens is cured, it becomes a “gel material.” (Tr. IV at 32 (Turner).) “So when the polymerization is complete, that entanglement ... is permanently retaining that PVP by physical interaction, just the entanglement. There’s no chemical reaction.” (Tr. VIII at 81 (Valint).)
The “cure” process is followed by the “extraction” step in which the lens is removed from the mold. Unwanted substances, such as unreacted ingredients, are removed. (Tr. IV at 32 (Turner).) The extraction step is vigorous, using a 70 percent isopropanol solution, a rubbing alcohol and water to clean the lens and extract impurities. (Id. at 32, 113; Tr. VII at 213 (Valint).) The extraction process lasts at least 30 minutes. (Tr. IV at 116 (Turner).)
The Acuvue Oasys lens is then “hydrated” by immersing the lens in a water and alcohol mixture, placed in a saline packing solution, packaged, and sterilized by “autoclaving.” (Id. at 37-38, 113.) This step involves contact with a liquid. (Tr. VIII at 66 (Valint).) During “hydration,” the lenses swell with the water like a sponge. (Tr. IV at 37 (Turner).)
One of the challenges encountered by J & J was keeping the hydrophillic PVP from leaching out of the lens during hydration. J & J chose the heavy-weight PVP molecule to better anchor the molecule in the polymerized network and avoid its leaching away upon hydration of the lens. (Tr. VII at 192 (Valint) (very large PVP molecule gets entangled into the polymer mesh).) The long PVP molecules provide “a very efficient way to get water content into the lens” and “tenaciously holds on to whatever water it brings in ... And it provides wettability to the whole construct of the lens, the internal part ... and provides wettability to the surface, too.” (Id. at 190; see also Tr. IV at 45 (Turner).) At the end of the process, there is PVP throughout the lens, including in the bulk of the lens and at its surface. (Tr. IV at 106-07 (Turner); Tr. VII at 191 (Valint) (a portion of a PVP is going to be at the surface).) Adding PVP to the composition, some of which rests at the surface of the lens, produces a very wettable, lubricious lens, contributing to the lens’ ability to permit tears to flow across the lens in the eye and resisting globs and deposits in the tear film. “[T]he use of PVP in the formulation produces a lens that is wettable on the eye.” (Tr. IV at 108-09 (Turner).) The Acuvue Oasys lens is more wettable and more ophthalmically compatible with the PVP wetting agent than without it. (Tr. VIII at 66, 68 (Valint).)
CIBA’s expert testified that the hydration step causes the hydrophillic PVP molecule to migrate to the surface of the Oasys lens. “[A]t the end of the process of curing, when the network has been formed and the PVP is entangled in it, they [J & J] wash the lens with a mixture of water and isopropanol, at least an aqueous solution of some sort. And that helps to draw out the PVP to the surface.” (Tr. Ill at 79 (Hoffman).) Being a non-reactive component of the lens, the PVP is “free to move.” {Id. at 83.) “And when you wash that out with an aqueous solution, it’s able to reptate its way ... like a snake, reptate its way through the network and out of the lens.... [T]hat gets it to the surface ... [and] helps to make the surface wettable.” {Id. at 84, 140 (Hoffman).) The hydration would naturally attract PVP molecules, or segments, to the surface, where they would remain as the rest of the molecule is entangled in the bulk. {Id. at 83-84.) CIBA relies on a J & J internal document written about the J & J hydrogel lens Acuvue Advance. That one-page document, entitled “HYDRACLEARtm” describes PVP in the lens as follows:
PVP is not covalently linked into the network; rather it is entangled in the crosslinked polymer network, since it was present (in solution with the other components) while the reactive monomer mix was polymerizing. It has limited mobility inside the bulk of the lens, and migrates ever so slowly out of the lens (<1.5%/month). The fact that it associates so well with water results in its great molecular mobility.... It is therefore very flexible in the crosslinked matrix where it acts as an internal wetting agent. Since it does migrate to the surface, it contributes to the wettability at the surface of the lens as well.
(DTX 85 (emphasis added)); see also DTX 289 (J & J 2005 memorandum discussing HYDRACLEARtm “breakthrough technology that combined the oxygen transmissibility of silicone with exceptional wettability and low modulus from an internal wetting agent (PVP)”).
CIBA acknowledges that migration of PVP in the Acuvue Oasys does not occur during the “cure” step, and that after “curing” the polymer mesh is fully formed. {See Tr. Ill at 139-40 (Hoffman).) CIBA’s position is that J & J’s use of nonreactive PVP in the formulation, coupled with J & J’s manufacturing process involving the application of an energy source during the “cure” step and contact with liquid during the extraction and hydration steps, results in the Acuvue Oasys lens surface being more wettable and ophthalmically compatible. The use of a nonreactive polymeric additive such as PVP to “modify” the surface has been commonly understood to be a “surface treatment process,” argues CIBA, and meets the “surface modified by a surface treatment process” limitation. (Doc. 311 (Tr. 17,19).)
In response, J & J characterizes the Acuvue Oasys as a “monolith.” J & J expert Valint testified that the Oasys “is inherently wettable because of its composition .... There is no process there that involves surface treatment” or a modified surface, argues J & J. (Tr. VII at 197 (Valint); Doc. 311 (Tr. 69).) The addition of PVP does not constitute a surface treatment, but rather is a part of a monolithic inherently wettable lens. (Tr. VII at 92, 199 (Valint).) To J & J, a “surface treatment” as defined in the CIBA patent is “an additional process step beyond what is commonly used for soft contact lenses.” (Tr. IV at 117 (Turner); PTX 1019.)
In support of its monolith argument, J & J cites to x-ray photoelectron spectroscopy (“XPS”) testing done by CIBA to determine and compare the concentration of nitrogen atoms, an element found in PVP, on the surface with the bulk of the Acuvue Oasys. J & J contends that the test establishes that the amount of nitrogen at the surface of the Oasys lens is not greater than the amount to be expected if the Acuvue Oasys were a homogeneous material with PVP evenly distributed throughout, and not enriched at the surface. (Doc. 286 at 28; Tr. Ill at 169-83 (Hoffman); Tr. VII at 206-07 (Valint) (CIBA testing shows surface of Acuvue Oasys is “essentially the same or slightly less in terms of the total nitrogen as the calculated total lens ... formulation”); Tr. VIII at 74-77 (Valint); PTX 501.) J & J also cites to a “contact angle” test which it performed and which it contends illustrates that the wettability of the surface of the Acuvue Oasys lens is the same as the wettability of the core, measured on an exposed portion of the lens’ bulk material. (Doc. 286 at 28; Tr. VII at 201-04 (Valint); Tr. Ill at 148-49 (Hoffman).)
J & J expert Valint disagrees with CIBA’s migration theory, asserting that the large size and weight of the PVP molecule precludes migration “because it is being effectively entangled into the network of the polymer that’s being built from the rest of the constituents of the Oasys formulation ... essentially locking that ... into that total construct.” (Tr. VII at 209-10 (Valint).) Further, J & J contends that “[i]f the PVP were to migrate to the lens surface, the PVP would simply be washed away and therefore leave the lens altogether, decreasing its water content.” (Doc. 286 at 28.) J & J argues that the stability of the PVP is confirmed by the fact that the Acuvue Oasys has a shelf life of six years, and retains a water content of 38 percent during that period. However, J & J expert Valint conceded that as a result of the polymerization process, there is a distribution of molecular weights of PVP — some very big, and some small — and that “[t]he small ones will leach out of the lens during the processing of the material, yes, during the extraction process.” (Tr. VIII at 79-80 (Valint).)
The Court holds that “surface modified by a surface treatment process” requires a showing that a lens is more ophthalmically compatible with the surface treatment process than without it, and that, by means of contact with a vapor or liquid, and/or by means of the application of an energy course, the surface properties of the lens are modified. The components of surface treatment process- — -“contact with liquid or vapor” and/or “application of an energy source” are not required by the patent to be applied to the surface of the lens. (Tr. Ill at 75 (Hoffman).) A “surface modified by a surface treatment process” is not limited to a post-manufacturing process, nor does it require that the surface of the lens be more hydrophillic than the core. The Court finds that the surface of the Acuvue Oasys is more ophthalmically compatible as a result of the addition of the non-reactive molecule PVP plus the process by which the PVP molecule is entangled in the polymer mixture of the lens allowing portions of the hydrophillic wetting agent to remain at the surface of the lens.
That the Oasys’ PVP wetting agent is non-reactive distinguishes the Acuvue Oasys lens from non-surface treated lenses cited by J & J, including CIRA patent Example D-2 ('100 Patent col. 59 1. 58-col. 60 1. 13 and col. 68 Table G) and prior art conventional hydrogels with no surface treatment. (See Doc. 286 at 30.) These comparisons are inapposite because their wetting agents — DMA and methacrylic acid- — -are reactive “ionoperm polymerizable materials,” while the PVP in the Acuvue Oasys is non-reactive, remaining a homopolymer throughout the manufacturing process.
The addition and presence of PVP in the lens in and of itself does not constitute a “surface treatment process.” The evidence establishes that the “cure” step— with its application of an energy source in the form of light — entangles the large (long) and heavy PVP molecule in the bulk, preventing it from escaping out of the lens in its entirety when the lens is exposed to liquid during hydration, storage and wear. As a result of the “cure,” through the application of an energy source, a portion of that anchored PVP molecule is positioned at the surface. This PVP at the surface makes the surface hydrophilic and wettable, and thus more ophthalmieally compatible. (See DTX 154 at V830422 (J & J “Phoenix” diagram illustration of lens entitled “PVP: Wetting Agent”); Tr. IV at 106 (Turner) (“all the materials are uniformly mixed, there’s PVP in the middle of the lens, there’s PVP pieces — bits and pieces, loops, whatever, near the surface of the lens. It’s all throughout.”).) “[T]he very fact that you put PVP into the formulation means that some of it is ... at or near the surface, some of it is in the bulk. And that obviously plays a role in the wettability.” (Tr. IV at 108-09 (Turner); Doc. 311 (Tr. 72).) The goal of the Oasys “surface treatment process” was to lock the PVP (HydraClear Plus) into the lens, permitting it to remain in and at the surface of the Oasys lens to provide wettability, while preventing the PVP from leaching out of the lens. (See Tr. IV at 106 (Turner) (the higher molecular weight PVP is used so it will be trapped in the mesh or network within the lens and will not leach out).)
The CIBA claim term does not require that there be a post-manufacturing “surface treatment process,” or that the surface be more hydrophillic than the bulk. (See Tr. Ill at 115 (Hoffman) (“It doesn’t matter what the core is like. What really matters is that the surface is more wettable than it was before you added the PVP”); id. at 134 (“If you have modified the wettability of the surface by adding PVP to the system, whether there’s more or less on the surface than the bulk doesn’t matter. You have modified the wettability of the surface. That’s a surface treatment process.”).) Other non-asserted claims in the patent series specifically express this “post-manufacturing” limitation which is not to be imported into the asserted claims. (See '461 Patent els. 1,12, and 14). Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1368 (Fed.Cir.2005) (“The doctrine of claim differentiation stems from ‘the common sense notion that different words or phrases used in separate claims are presumed to indicate that the claims have different meaning and scope.’ ” (citation omitted)). The surface “modification” occurs during the “surface treatment process” as the lens and its surface are being formed, not after. (See DTX 1273.)
The Court’s holding that the Acuvue Oasys meets the “surface modified by a surface treatment process” limitation in the CIBA patents does not come without reservation. The CIBA specifications do not appear to contemplate a very hydrophillic homopolymer being entangled in the network of polymers during polymerization and lodging, in part, at the surface as a result of the polymerization process. Rather, the CIBA specifications refer to either a post-manufacturing “coating” or “grafting” of a material on the surface, or “altering the surface properties of a lens involving] treatment prior to polymerization to form the lens.” J & J does neither of these — it adds PVP to the initial mixture, and polymerizes the mixture such that the non-reactive PVP does not polymerize but gets entangled in the materials that do. Without question, J & J’s use of high molecular weight PVP, its “cure” process, and the resultant structure of the Acuvue Oasys lens is innovative; no other silicone hydrogel lenses have this. (Tr. X at 50 (CIBA expert Dr. Jimmy Wayne Mays (“Mays”)).) But, while J & J has succeeded in constructing an innovative lens that is different from CIBA’s commercial embodiment of its invention, or even the embodiments described in the patent specifications, J & J’s invention, nevertheless falls within the broad scope of CIBA’s claims, which defines the scope of CIBA’s right to exclude. The accused product, the Acuvue Oasys, must be compared to the claim language as interpreted. Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448, 1454 (Fed.Cir.1998). “‘It is the claims that measure the invention,’ ” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1325 (Fed.Cir.2003) (citation omitted), and the claims are not to be limited to the embodiments disclosed in the specification. Id., at 1328. “[T]he scope of the asserted claims may be ascertained from the plain language of the claims.” Prima Tek II, L.L.C. v. Polypap, S.A.R.L., 318 F.3d 1143, 1151 (Fed.Cir.2003).
The “law allows for after-arising technology to be captured within the literal scope of valid claims that are drafted broadly enough.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1371-72 (Fed.Cir.2008); see also, SuperGuide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 876-79 (Fed.Cir.2004) (patent terms did not limit the scope of the claimed invention to analog technology, but rather, covered digital signals; patentees were aware of the existence of analog and digital signals and did not explicitly limit the disputed claim language to technologies that were “conventional” at the time of the invention). “ ‘The law ‘does not require that an applicant describe in his specification every conceivable and possible future embodiment of his invention.’ ’ ” SuperGuide Corp., 358 F.3d at 880 (quoting SRI Int'l, v. Matsushita Elec. Corp. of America, 775 F.2d 1107, 1121 (Fed.Cir.1985)). The broad language of the term as construed— “the surface properties of an article are otherwise modified” — reaches the J & J’s Acuvue Oasys lens; the broad coverage of the “surface modified by a surface treatment process” limitation, as construed, affords CIBA the right to exclude J & J’s Acuvue Oasys lens. CIBA has proved by a preponderance of the evidence that the Acuvue Oasys infringes upon the “surface modified by a surface treatment process” term found in '100 Patent els. 1, 28 and '811 Patent els. 28., 29.
3. Lack of “polyvinylpyrrolidone at a surface of said lens”
Dependent claim 96 of the '894 Patent recites: “The contact lens of claim 89 further comprising polyvinylpyrrolidone [PVP] at a surface of said lens.” J & J contends that to infringe upon this claim, the accused contact lens must have the entire molecule of PVP at the surface of the lens. CIBA argues that the claim term does not require that the entire molecule be at the surface, and that the claim term is met by J & J’s Acuvue Oasys because a portion of the PVP molecule rests at its surface. (See Tr. Ill at 74, 126-27 (Hoffman).) Neither party sought construction of the limitation PVP “at a surface” of the lens during the Markman proceedings; they both seek a construction of the term now.
J & J contends that claim 96 requires the “homopolymer” PVP be at the surface of the lens, “not simply a few NVP chemical groups that form a portion of the PVP” at the surface. (Doc. 303 at 15.) “The evidence established that while some NVP units contained within the homopolymer are at the surface of the Oasys lens, the entire PVP homopolymer molecules are not.” (Doc. 286 at 31 (citation omitted).) CIBA expert Valint testified that “a portion of a PVP molecule is going to be at the site. It ... better not be totally there, because it won’t remain there.” (Tr. VII at 191 (Valint); see also Tr. IV at 106-08 (Turner) (bits and pieces of PVP at the surface of the lens); Tr. Ill at 78 (Hoffman) (PVP “ends up at the surface of the [Oasys] lens”).) “[0]nly a small portion ... of that [PVP] molecule can reside ... at or near the surface, because otherwise it would be lost____[A] major share of the molecule has to be entangled into the lens matrix in order for it to remain and be a stable contact lens.” (Tr. VIII at 79 (Val-int)).
J & J cites the F-Examples of the '100 Patent ('100 Patent col. 64 1. 60-col. 67 1. 40), which teach that “the lens surface is coated with polyvinylpyrrolidone,” as the only CIBA patent disclosures teaching PVP “at a surface.” The examples disclose a lens with a “PVP co-polymer” with crosslinks covalently and chemically attached to the surface of the lens as “a covalently bound coating.” (Doc. 286 at 31.) According to J & J, the F Examples demonstrate that claim 96 teaches that the entire PVP molecule must be at the surface of the lens. J & J expert- Valint opines that the Acuvue Oasys does not infringe upon claim 96 of the '894 Patent because “[t]he CIBA patent is teaching coating by plasma polymerization [of] an existing contact lens. And that ... co-polymer of polyvinylpyrrolidone is being chemically attached during this formation in the plasma chamber. J & J is teaching mixing all the ingredients together, putting them in the molds, and you just get a physical entanglement that does not allow the PVP to escape out of the lens.” (Tr. VIII at 81-83 (Valint) (discussing the surface treatment in the F Examples).) CIBA responds that the F Examples teach a surface treatment process which results in a homopolymer PVP at the surface of the lens that is produced by the polymerization of NVP. (Tr. 1 at 153-56 (Winter-ton); Tr. X at 33, 57, 59, 61 (Mays).) CIBA cites by contrast to claim 97 of the '894 Patent which teaches a contact lens dependent upon claim 96 “wherein said polyvinylpyrrolidone coats said surface of said lens.”
J & J’s discussion of the structure of one of CIBA’s preferred embodiments is not determinative of the construction here. See Phillips, 415 F.3d at 1323 (“although the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments”); Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed.Cir.1998) (“ ‘[although the specification may aid the court in interpreting the meaning of disputed claim language, particular embodiments and examples appearing in the specification will not generally be read into the claims’ ”) (citation omitted). Further, under the doctrine of claim differentiation, “ ‘the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.’ ” Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244, 1251 n. 3 (Fed.Cir.2008) (quoting Phillips, 415 F.3d at 1315). Inasmuch as claim 97 is dependent upon claim 96, the limitation in the latter claim creates the presumption that the PVP referred to in claim 96 is not to be characterized to require that the PVP “coats said surface” as J & J suggests. J & J has presented no evidence to overcome that presumption.
J & J’s proposed construction of the term “PVP at a surface” as meaning that the entire PVP molecule must be located at the surface of the lens results in an impossibility; if the entire hydrophillic molecule were lying at the surface, it would wash away. Thus, pursuant to J & J’s claim construction, no contact lens would ever meet the CIBA claim limitation or infringe upon it. (Tr. VIII at 83-84 (Valint).) ‘“[A] construction that renders the claimed invention inoperable should be viewed with extreme skepticism.’ ” Cordis Corp. v. Medtronic Ave, Inc., 511 F.3d 1157, 1174 (Fed.Cir.2008) (citation omitted), cert. denied — U.S. -, 129 S.Ct. 201, 172 L.Ed.2d 142 (2008); cf. Honeywell Int’l, Inc. v. Int’l Trade Comm’n, 341 F.3d 1332, 1341 (Fed.Cir.2003) (“an inoperable claim construction would render the claim invalid for lack of enablement”).
The Court agrees with CIBA that the claim language says PVP “at a surface of said lens” and not PVP “on a surface.” The Court declines to import a limitation into claim 96 of the '894 Patent that requires that the entire molecule of PVP be lying “at a surface” of the lens. See N. American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1348 (Fed.Cir.2005) (“unless required by the specification, limitations that do not otherwise appear in the [patent] claims should not be imported into claims”). The Court holds that “polyvinylpyrrolidone at a surface of said lens” requires that some portion of the PVP homopolymer molecule be present at the surface of the lens, and finds that under this construction, CIBA has proven by a preponderance of the evidence that the Acuvue Oasys meets this limitation.
4. Lack of phases
Three asserted claims from the '100 Patent teach that the patented contact lens has “phases.” ('100 Patent els. 1, 28, 56.) Independent claims 1 and 56 both include the following “phase” limitation:
wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material ...
('100 Patent els. 1, 56) Claim 28 is dependent on claim 1. The parties agreed to the following construction of the claim term “phase”:
A “phase”, as used herein, refers to a region of substantially uniform composition which is a distinct and physically separate portion of a heterogeneous polymeric material. However, the term “phase” does not imply that the material described is a chemically pure substance, but merely that certain bulk properties differ significantly from the properties of another phase within the material. Thus, with respect to the polymeric components of a lens, an ionoperm phase refers to a region composed of essentially only ionoperm polymer (and water, when hydrated), while an oxyperm phase refers to a region composed of essentially only oxyperm polymer.
(Doc. 121 at 17.) It is the verbatim recitation of the definition of “phase” found in the specifications. (See '100 Patent col. 5 11. 20-31.) The Court construed the claim term “phases substantially separate” to mean “at least two ‘phases’ as ‘phase’ is previously defined.” (Doc. 121 at 41-42.)
Relevant to the issue of “phases” are the terms “oxyperm polymerizable material” and “ionoperm polymerizable material,” which describe the material comprising the phases. ('100 Patent els. 1, 28, 56.) The patent specifications specifically define these terms as follows:
oxyperm polymerizable material:
A “polymerizable material which is capable of polymerizing to form a polymer having a high oxygen permeability” as used herein, refers to monomers, oligomers, macromers, and the like, and mixtures thereof, which are capable of polymerizing with like or unlike polymerizable materials to form a polymer which displays a relatively high rate of oxygen diffusion therethrough. For convenience of reference, these materials will be referred to herein as “oxyperm polymerizable materials” and the resultant polymers will be referred to herein as “oxyperm polymers”.
('100 Patent col. 4 11. 40-50 (emphasis added)) and
ionoperm polymerizable material:
A “polymerizable material which is capable of polymerizing to form a polymer having a high ion permeability” as used herein, refers to monomers, oligomers, macromers, and the like, and mixtures thereof, which are capable of polymerizing with like or unlike polymerizable materials to form a polymer which displays a relatively high rate of ion or water permeation therethrough. For convenience of reference, these materials will be referred to herein as “ionoperm polymerizable materials” and the resultant polymers will be referred to herein as “ionoperm polymers”.
('100 Patent col. 5 11. 3-12 (emphasis added)).
Related to the claim term “phase” is the term “pathways,” also found in asserted claims 1, 28 and 56. The patent specifications refer to the term “pathways” concurrently with “phase,” shedding light upon the function of a “phase”:
The existence of separate oxyperm and ionoperm phases, rather than a complete blend of oxyperm and ionoperm phases, is believed to be advantageous in promoting the diffusion of oxygen and ions. Oxygen will diffuse predominantly through the oxyperm polymer, while the ionoperm polymer provides a higher barrier to oxygen diffusion. Similarly, ions will diffuse well through the ionoperm polymer, but the oxyperm polymer provides a higher resistance to ion diffusion. Thus, one homogeneous oxyperm/ionoperm phase will provide undesirable resistance to both oxygen and ion diffusion, while two separate oxyperm and ionoperm phases will provide low resistance pathways for transmission of both oxygen and ions or water. Thus, the ideal extended-wear lens has a pathway or series of pathways from the outer surface to the inner surface for transmission of oxygen therethrough, and an analogous continuous pathway or series of pathways for transmission of water or ions therethrough. In a particularly preferred embodiment, the lens has two co-continuous phases, one an oxyperm phase and the other an ionoperm phase, allowing for permeation of water or ions and oxygen between the front and base curves of the lens.
('100 Patent col. 8 11. 40-61 (emphasis added).) The Court, however, declined to construe “pathway” as being interchangeable with the term “phase,” observing that “ ‘pathways’ refers to and defines the function of ‘phases’ as opposed to the chemical composition.” (Doc. 121 at