Johnson & Johnson Vision Care, Inc. v. Ciba Vision Corp. (540 F. Supp. 2d 1233, 2008)

CORRECTED MARKMAN ORDER

TIMOTHY J. CORRIGAN, District Judge.

This consolidated case pertains to CIBA Vision Corporation’s (“CIBA”) six patents for extended-wear contact lenses, and related methodology. In Case No. 3:05-cv-125-J-32TEM, Johnson & Johnson Vision Care, Inc. (“J & J”) brought an action for declaratory judgment against its competitor CIBA, seeking a declaration that CIBA United States 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”) (collectively “the Nicolson patents” or “CIBA patents”) are invalid and/or unenforceable, and alternatively that J & J’s new silicone hydrogel contact daily wear lenses, the Phoenix contact lens, to be marketed under the name ACUVUEOOASYStm, does not infringe upon the CIBA patents. (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-310-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,” entitled “Extended Wear Opthalmic Lens.” J & J counterclaimed, seeking a declaration that the '894 Patent is invalid and unenforceable. This matter is before the Court for patent claim construction, as described in Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed.Cir.1995)(en bane), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The Court has considered the voluminous submissions by the parties, including memoranda, summaries, charts, and exhibits (Docs.84, 86, 87, 90, 91, 92, 94), as well as argument of counsel at a day-long Markman hearing held on July 25, 2007.

I. Background

The six patents at issue in this case (“the CIBA patents”) stem from a single application for the '100 Patent entitled “Extended Wear Ophthalmic Lens,” which was filed with the United States Patent & Trademark Office (“USPTO”) on December 8, 1995. (Doc. 84-23.) The original application presented 158 claims and listed 19 inventors from all over the world. The original application was subsequently divided into four distinct patent applications which eventually resulted in the '100, '811, '999, and '461 Patents. The patents, informally referred to by the name of the lead inventor, Dr. Paul C. Nicolson, include both device and method patents, along with divisional and continuations thereof.

The CIBA patents relate to silicone hy-drogel lenses suitable for extended continuous wear periods of at least 24 hours to up to 30 days. The '100 Patent describes the requirements for the invention.

One ophthalmic compatibility requirement for contact lenses is that the lens must allow oxygen to reach the cornea in an amount sufficient for long-term corneal health. The contact lens must allow oxygen from the surrounding air to reach the cornea because the cornea does not receive oxygen from the blood supply like other tissue. If sufficient oxygen does not reach the cornea, corneal swelling occurs. Extended periods of oxygen deprivation causes the undesirable growth of blood vessels in the cornea. “Soft” contact lenses conform closely to the shape of the eye, so oxygen cannot easily circumvent the lens. Thus, soft contact lenses must allow oxygen to diffuse through the lens to reach the cornea.

Another ophthalmic compatibility requirement for soft contact lenses is that the lens must not strongly adhere to the eye. Clearly, the consumer must be able to easily remove the lens from the eye for disinfecting, cleaning, or disposal. However, the lens must also be able to move on the eye in order to encourage tear flow between the lens and the eye. Tear flow between the lens and eye allows for debris, such as foreign particulates or dead epithelial cells to be swept from beneath the lens and, ultimately, out of the tear fluid. Thus, a contact lens must not adhere to the eye so strongly that adequate movement of the lens on the eye is inhibited.

('100 Patent col. 1 11. 29-53.) The patents sought to address these two ophthalmic compatibility requirements.

CIBA’s patented contact lens addresses the first requirement, providing for a flow of oxygen through the lens to the cornea of the eye, by incorporating “phases” into its lens structure. The purpose of the phases is for the oxygen to reach the cornea of the eye by diffusing through the oxyperm material, whereas the ions and water move back and forth and diffuse through the ionoperm material. The '100 Patent specifies:

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 iono-perm polymer, but the oxyperm polymer provides a higher resistence to ion diffusion.

('100 Patent col. 811. 40-48.)

The USPTO issued the '100 Patent on June 2, 1998. CIBA released the silicone hydrogel extended wear lenses protected by these patents under the name Focus® NIGHT & DAY™, providing, until recently, the only 30-day extended wear lenses on the domestic market. (See Doc. 49 at S.)

Competitor Bausch & Lomb, Inc. (“B & L”) requested a reexamination of four of CIBA’s patents ('100, '999, '461, and '811 patents), relying on its own patent, U.S. Patent No. 5,034,461 by Dr. Yu-Chin Lai (“Lai '461 Patent”). (See Doc. 21 at 4.) In March 1999, the USPTO opened reexamination proceedings for the '811 patent and all of the other then-issued Nicolson patents to examine them in light of the Lai '461 Patent. (Doc. 34 at 7.) Initially, some of the claims in the CIBA patents were rejected as anticipated by prior art and obvious in light of the Lai '461 Patent. (Doc. 84-6 at 19.) However, based on submissions by CIBA, the examiner determined that the amendments to the patents and the arguments made by CIBA overcame all pending rejections. (See Doc. 84-6 at 21 (J & J Ex. 4).) Reexamination certificates were issued by the USPTO on Patents '100, '999, '811, and '461 in November, 2000.

On March 8, 1999, CIBA brought an infringement action against B & L in the United States District Court for the Northern District of Georgia, 2:99-cv-0034-RWS (“B & L case”), alleging that B & L’s 30-day extended day silicone hydro-gel lenses, marketed under the PureVision™ name, infringed upon the '100, '999, '461, and '811 patents. B & L argued that it, not CIBA, was the first to invent extended wear silicone hydrogel contact lenses, particularly referring to prior art, the Lai '461 Patent and the Nandú Patent (U.S. Patent No. 5,260,000). (See Docs. 21 at 4; 23 at 16; 49 at 4.) The Georgia Court stayed the case pending the reexamination proceedings, and reopened the case on March 28, 2001. The Georgia District Court issued its Markman claim construction on March 14, 2003, which is much discussed in this case. Following a 23 day trial, but before the issuance of an opinion, CIBA and B & L reached a settlement in July 2004, and the district judge signed a consent decree on July 23, 2004.

J & J contends that its new Oasys lenses are soft silicone hydrogel contact lenses that, unlike the older silicone hydrogel lenses sold by CIBA and B & L, do not require a surface treatment for the lens to be wearable. The Oasys lenses have been manufactured at J & J’s facilities in Jacksonville since late 2004. (Doc. 34 at 5.) In November 2004, J & J received U.S. Food and Drug Administration (“FDA”) approval to sell the Oasys lens as a daily wear lens only. (Doc. 34 at 7.) In 2005, the product was sold in Europe, and J & J was in the midst of launching the product in the United States. (Doc. 34 at 6.)

II. Claim Construction Standards

A patent describes the scope and limits of an invention to alert the public to what exclusive rights the patentee holds, and by the same token, what remains open to the public. Markman, 52 F.3d at 978. A patent consists of claims which should “particularly point[ ] out and distinctly claim[ ] the subject matter which the applicant regards as his invention.” E.g., Howmedica Osteonics Corp. v. Tranquil Prospects, Ltd., 401 F.3d 1367, 1371 (Fed.Cir.2005); 35 U.S.C. § 112. A determination of patent infringement requires a two-step analysis: first, the meaning of the claim language is construed, then the facts are applied to determine if the accused device falls within the scope of the claims as interpreted. Markman, 52 F.3d at 976.

Patent claims are construed by the Court as a matter of law. Cybor Corp. v. FAS Techs, Inc., 138 F.3d 1448, 1454-56 (Fed.Cir.1998)(en banc). “It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to which the patentee is entitled the right to exclude.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005)(en banc)(quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed.Cir.2004)). “[T]he words of a claim ‘are generally given their ordinary and customary meaning.’ ” Phillips, 415 F.3d at 1312 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996)). Such ordinary meaning “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.” Id. at 1313. “Courts construe claim terms in order to assign a fixed, unambiguous, legally operative meaning to the claim.” Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1377 (Fed.Cir.2005).

In claim construction, courts first examine the patent’s intrinsic evidence to define the patented invention’s scope. See Phillips, 415 F.3d at 1312. This intrinsic evidence includes the claims themselves, the specification, and the prosecution history. See Phillips, 415 F.3d at 1314; C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 861 (Fed.Cir.2004).

Claim construction begins with the words of the claims themselves. Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1301 (Fed.Cir.2006); Phillips, 415 F.3d at 1312. The task of comprehending these words is not always a difficult one. “‘In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words.’ ” Acumed LLC v. Stryker Corp., 483 F.3d 800, 805 (Fed.Cir.2007)(quoting Phillips, 415 F.3d at 1314). However, a patent “specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess.” Acumed, 483 F.3d at 805. “In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. Further, a “person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips, 415 F.3d at 1313; see also Markman, 52 F.3d at 979 (holding that claims “must be read in view of the specification, of which they are a part”).

“When dealing with technical terms, ... a court should look to ‘the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.’ ” Amgen Inc., 457 F.3d at 1301 (quoting Phillips, 415 F.3d at 1313). Other asserted or unasserted claims can also aid in determining the claim’s meaning because claim terms are typically used consistently throughout the patent. Phillips, 415 F.3d at 1314. Differences among the claim terms can also assist in understanding a term’s meaning. Id. For example, when a dependent claim adds a limitation to an independent claim, it is presumed that the independent claim does not include the limitation. Id. at 1314-15.

“[T]he 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.” Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996)); Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed.Cir.2002). This is true because a patentee may define his own terms, give a claim term a different meaning than the term would otherwise possess, or disclaim or disavow the claim scope. Phillips, 415 F.3d at 1316. Also, the specification may resolve ambiguous terms “where the ordinary and accustomed meaning of the words used in the claims lack sufficient clarity to permit the scope of the claim to be ascertained from the words alone.” Teleflex, Inc., 299 F.3d at 1325. “ ‘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.’ ” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed.Cir.1998) (citation omitted); see also Phillips, 415 F.3d at 1323. Occasionally “the specification may reveal a special definition given to a claim term ... that differs from the meaning it would otherwise possess.” Phillips, 415 F.3d at 1316. The specification may also “reveal an intentional disclaimer, or disavowal, of claim scope by the inventor ..., [which] is regarded as dispositive.” Id.

The prosecution history is another tool to supply the proper context for claim construction because a patent applicant may also define a term in prosecuting the patent. Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1356 (Fed.Cir.2004). However, because the prosecution history represents negotiation between the USPTO and the applicant, “it often lacks the clarity of the specification and thus is less useful for claim construction purposes.” Phillips, 415 F.3d at 1317. Nevertheless, the prosecution history can be helpful “by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of the prosecution.” Id. “Disclaimers based on disavowing actions or statements during prosecution, however, must be both clear and unmistakable.” Sorensen v. Int’l Trade Comm’n, 427 F.3d 1375, 1378-79 (Fed.Cir.2005). Further, it is the applicant and not the examiner who must “ ‘give up or disclaim subject matter’ ” that would otherwise be included within the scope of the claim. Sorensen, 427 F.3d at 1380 (citation omitted). The statement of an examiner alone will not necessarily limit a claim. Bell Atlantic Network Servs., Inc. v. Covad Commc’ns Group, Inc., 262 F.3d 1258, 1273 (Fed.Cir.2001).

Though not preferred over intrinsic evidence, the Court may also rely on extrinsic evidence, which is “all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d at 980. “Extrinsic evidence in the form of expert testimony can be useful to a court for a variety of purposes, such as to provide background on the technology ..., to explain how an invention works, to ensure that the court’s understanding of the technical aspects of the patent is consistent with that of a person of ordinary skill in the art, or to establish that a particular term in the patent or prior art has a particular meaning in the pertinent field.” Conoco, Inc. v. Energy Envtl. Int'l, L.C., 460 F.3d 1349, 1362 (Fed.Cir.2006)(citing Phillips, 415 F.3d at 1318). Although extrinsic evidence can be useful, it is “less significant than the intrinsic record in determining the ‘legally operative meaning of claim language.’ ” Phillips, 415 F.3d at 1317 (citation omitted). Technical dictionaries and treatises may help a court understand the underlying technology and the manner in which one skilled in the art might use claim terms. However, technical dictionaries and treatises may provide definitions that are too broad or may not be indicative of how the term is used in the patent. Id. at 1321-22. Similarly, expert testimony may aid the court in understanding the underlying technology and determining the particular meaning of a term in the pertinent field, but an expert’s conclusory unsupported assertions as to a term’s definition are entirely unhelpful to the court. Id. at 1318. Generally, extrinsic evidence is “less reliable than the patent and its prosecution history in determining how to read claim terms.” Id.

Finally, claim construction must proceed “without regard to the accused device.” Optical Disc Corp. v. Del Mar Avionics, 208 F.3d 1324, 1333 (Fed.Cir.2000); Young Dental Mfg. Co., Inc. v. Q3 Special Prods., Inc., 112 F.3d 1137, 1141 (Fed.Cir.1997).

III. Northern District of Georgia Mark-man Order

On March 14, 2003, the Northern District of Georgia, the Honorable Richard W. Story, United States District Judge, entered a Markman order in the B & L case, construing many of the same terms proffered for claim construction by the parties here. CIBA Vision Corp. v. Bausch & Lomb, Inc., No. 2:99-CV-0034-RWS (N.D.Ga. March 14, 2003). (E.g., Doc. 87 Ex. G.)

While uniformity of treatment of a given patent is important, Markman, 517 U.S. at 390, 116 S.Ct. 1384, and Judge Story’s previous decision is entitled to “reasoned deference” under the broad principles of stare decisis and the goals articulated in Markman, the Court is not bound to automatically accept the claim construction by Judge Story, as CIBA contends. Rather, the Court has an independent obligation to determine the meaning of the claims, and to render its own independent claim construction. See Visto Corp. v. Sproqit Technologies, Inc., 445 F.Supp.2d 1104, 1108 (N.D.Cal.2006); Precor Inc. v. Fitness Quest, Inc., No. C05-0993L, 2006 WL 2469123, at *1 (W.D.Wash. Aug. 23, 2006); Maurice Mitchell Innovations, L.P. v. Intel Corp., No. 2:04-CV-450, 2006 WL 1751779, at *4 (E.D.Tex. June 21, 2006)(unpublished opinions); Texas Instruments, Inc. v. Linear Technologies Corp., 182 F.Supp.2d 580, 586, 589-90 (D.Tex.2002); see generally McGinley v. Houston, 361 F.3d 1328, 1331 (11th Cir.2004)(the general rule is that a district judge’s decision does not bind another district judge); Ramos v. Boehringer Mannheim Corp., 66 F.3d 346, 1995 WL 540297, at *1 (Fed.Cir.l995)(“comity is not required between district courts, absent any basis for collateral estoppel”)

IV. The Court Does Not Make Indefiniteness Determinations At This Time

In response to CIBA’s proposed claim constructions, J & J asserts that thirteen terms are “too indefinite to construe” or “indefinite as a matter of law.” (See Docs. 94 at 30, 33, 36; 90-3; 90-4.) J & J argues here that because these terms are too indefinite to be construed, the Court should simply later hold the claims containing these terms to be invalid. (Tr. 111-12.)

The Federal Circuit advises that the Court must first construe the term, if possible, before engaging in a validity analysis of the claims. “[W]e have certainly not endorsed a regime in which validity analysis is a regular component of claim construction.” Phillips, 415 F.3d at 1327 (citing Nazomi Commc’ns, Inc. v. Ann Holdings, PLC, 403 F.3d 1364, 1368-69 (Fed.Cir.2005))(eautioning the construing court to not “put the validity cart before the claim construction horse”); see generally Landers v. Sideways, LLC., 142 Fed.Appx. 462, 468 (Fed.Cir.2005)(unpublished opinion)(inappropriate to focus on validity in the process of claim construction). The Court must first attempt to determine what the claim means before it can determine whether it is invalid for indefiniteness. Pharmastem Therapeutics, Inc. v. Viacell, Inc., 2003 WL 124149, at * 1 n. 1 (D.Del. Jan. 13, 2003). The issue of indefiniteness is not properly before the Court when construing claims.

The Court declines to make indefiniteness determinations here. The Court will consider the term, the constructions proposed by CIBA and by J & J, and construe the term where necessary. Validity questions may be raised at a later time in the proceedings.

V. The Claims

The six patents at issue present a total of some 251 claims, including both dependent and independent claims. Claim 1 of the reexamined '100 Patent is a representative independent apparatus claim, reciting many of the claim terms that the parties present for construction. It reads as follows (with emphasis on the disputed claim terms and phrases):

1. An ophthalmic lens having a surface modified by a surface treatment process, said lens having ophthalmically compatible inner and. outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids while having adequate movement on the eye with blinking to promote adequate tear exchange and without producing significant corneal swelling, without having substantial amounts of lipid adsorption, and without causing substantial wearer discomfort during a period of wear of at least 24 hours, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a) at least one oxyperm polymeriza-ble material and

(b) at least one ionoperm polymeriza-ble material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during the period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm po-lymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during the period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10 cm 2/sec or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5xl0~6 mm2/min. wherein said ion permeability is measured with respect to sodium ions.

VI. Claim Construction

A. Agreed Constructions

1. “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 iono-perm 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. (Docs. 94 at 19-20; 86 at 20; Tr. 176 (emphasis added).)

The parties agreed to the construction adopted by the Northern District of Georgia in the B & L ease. (See Doc. 87 Ex. G at ¶ 15.) It is the verbatim definition of “phase” found in the patent specifications. (-See e.g. '100 Patent col. 5 11. 20-31.) However, the meaning of the phrases in boldface are disputed by the parties.

2. “Co-continuous Phases”

“Co-continuous Phases” refers to at least two regions, each of substantially uniform composition which differs from the other, and each of which forms a continuous pathway from one surface of an article to another surface of an article. However, each “phase” need not be a chemically pure substance, but merely connotes that certain bulk properties differ significantly from the properties of another phase within the material. Thus, with respect to co-continuous oxyperm and ionoperm phases, the 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. (Docs. 94 at 22; 86 at 22 (emphasis added).)

The agreed-to construction of the term is that adopted by the Northern District of Georgia, (see Doc. 87 Ex. G at p. 8), which combines the verbatim definition for the term found in the patent specification, ('100 Patent col. 5 11. 35-39), with the patent’s explicit definition for the term “phase.” ('100 Patent col. 5 11. 20-31.) The patent’s definition of “co-continuous phases” goes on to say that “an ophthalmic lens having co-continuous phases of oxyperm polymer and ionoperm polymer will have two continuous pathways or sets of continuous pathways extending from the inner surface of the lens to the outer surface of the lens.” ('100 Patent col. 5 11. 39-43.)

3. “Polyvinyl pyrrolidone”

a homopolymer that is produced by the polymerization of N-vinylpyrrolidone. (Tr. at 145.)

4. “Biocompatible”

“Biocompatible” has the same meaning as “ophthalmically compatible.” (Docs. 86 at 38; 93-3 at 3.)

The parties agree that the terms “bio-compatible” and “ophthalmically compatible” are synonymous for purposes of construing the patents in this case. As discussed in the patent itself, “[i]n the field of ophthalmic lenses, and in particular in the field of contact lenses, a bio-compatible lens may be generally defined as one which will not substantially damage the surrounding ocular tissue and ocular fluid during the time period of contact. The phrase ‘ophthalmically compatible’ more appropriately describes the biocompatibility requirements of ophthalmic lenses.” ('100 Patent col. 1, 11. 22-28.)

5.“High Water Permeability”

the rate of water permeation through the lens, from one surface to another, of greater than about 0.2 x 10 cm2/sec (See Tr. at 222-24.)

B. Disputed Constructions

1. “Surface Treatment Process”

_J & J’s Proposed Construction_ “Surface treatment process” means a post-manufacturing process for rendering a surface of an existing lens more ophthalmically compatible by contacting the existing surface of the lens with a vapor or a liquid or by applying an energy source to the existing surface of the lens, but “surface treatment process” does not encompass the process of curing the lens materials or the process of hydrating the finished lens. (Doc. 94 at 15.) _CIBA’s Proposed Construction_ This claim element requires that the exterior faces of the lens be altered, at least in part, by a process (or processes) that renders the surface more ophthalmically compatible 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, or (4) the surface properties of an article are otherwise modified. However, the. aforementioned processes exclude a conventional Ya-suda process that was designed to drastically reduce water permeability; a conventional, non-wettable TMS plasma coating; and a process that results in a surface that is completely transient, i.e., changed from a hydro-philic (wettable) surface to a hydrophobic (non-wettable) surface when worn. (Doc. 86 at 23.)_

CIBA’s proposed construction reflects verbatim the construction made by the Northern District of Georgia in the CIBA v. B & L case. (See Doc. 87 (CIBA Ex. G at 9).)

The CIBA patent specification defines “surface treatment processes” as follows:

“Surface treatment processes” as used herein, refers to 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.

('100 Patent col. 42 11. 44-54.) The patent specification describes “a variety of methods disclosed in the art for rendering a surface of a material hydrophilic,” including coating or grafting onto a lens a hy-drophilic 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 the mold surface to differ in composition from the core of the prepolymerization mixture.” ('100 Patent col. 42 11. 53-67 to col. 43 11. 1-3.)

Focusing upon the prosecution history, J & J contends that CIBA overcame an obviousness objection on reexamination of the CIBA patents by distinguishing its invention from the Lai '461 Patent prior art which taught adding the surface wetting agents during manufacture. Thus, argues J & J, the “surface treatment process” contemplated by the CIBA patents “necessarily means the surfaces already exist before being treated.” (E.g. Docs. 84-34 at 46 (J & J Ex. 29); 94 at 17; Tr. 100-01). Specifically, inventor Nicolson represented to the USPTO on re-examination that “one does not find any prior art on the surface modification of silicone hydrogels prior to our patents.” (Doc. 84-5 at 8 (J & J Ex. 3).) In doing so, according to J & J, CIBA specifically disclaimed the pre-polymer addition of a wetting agent and equated “surface treatment process” to a “post-manufacturing” process, treating the surface of the lens after the lens is made. (Tr. 93-94, 103.) J & J also contends that the language of the defining specification ('100 Patent col. 42 11. 44-45) is consistent and should be read as providing that the treatment process is applied to an existing surface to make it more ophthalmically compatible. (Tr. 95).

CIBA contends that rather than making a clear and unmistakable disclaimer during the reexamination procedure, it sought to demonstrate how the Lai '461 Patent prior art failed to solve the wettablity and lipid absorption problem and thus, under Federal Circuit law, establish the non-obviousness of the claimed CIBA invention. (Doc. 84-34 at 45) (J & J Ex. 29)(“failure of others to satisfy a long-felt need or develop a commercially successful product is evidence of non-obviousness”)(citing Dow Chem. Co. v. American Cyanamid, Co., 816 F.2d 617, 623 (Fed.Cir.1987).) CIBA contends that its prosecution argument on reexamination was that “there’s no successful prior art on surface modification of silicone hydrogels out there .... you don’t find any successful prior art on the surface modification.” (Tr. at 87.)

The Court finds that CIBA was its own lexicographer when it defined “surface treatment process” in the patent specification. The statement by inventor Nicolson to the USPTO examiner was not sufficient to clearly and unmistakably disclaim and limit the definition set forth in the specifications to being post-manufacturing. Purdue Pharma L.P. v. Endo Pharm., Inc., 438 F.3d 1123, 1136 (Fed.Cir.2006). While the Court of course considers the claim construction of its sister court in the Northern District of Georgia, the parties have provided no basis for embracing the language added by that court to the claim construction. Accordingly, the term “surface treatment process” shall be construed as defined by the patent specification:

“Surface Treatment Process”

“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.

2. Whether All Claims Require Surface “Surface Modification” and “Co-Continuous Phases”

_J & J’s Proposed Construction_CIBA’s Proposed Construction_ All of the claims at issue are limited to “Co-continuous pathways” or “phases” are require “surface modification” and “co-con- not a claim requirement for claims that do tinuous phases.” (Docs. 94 at 10; 90-3 at 2.) not expressly recite them. (Doc. 86 at 23.) Surface treatment process is not a claim requirement for claims that do not expressly recite this limitation. (Doc. 86 at 37 (App.A); _Doc. 91-2 at 7 (Response Ann. 1))_

Multiple claims in the CIBA patents recite the phrase: “surface modified by a surface treatment process.” (E.g. '100 Patent cl. 1, 44, 49-54, 59.) CIBA embraces the construction by the Northern District of Georgia, which held that “ ‘co-continuous pathways’ or ‘phases’ are not a claim requirement for claims that do not expressly recite them.” (Doc. 87 (CIBA Ex. G at 9).) As to both terms, CIBA argues that the Court should not read unstated claim limitations into claim language, see Northern Telecom Ltd. v. Samsung Electronics Co., Ltd., 215 F.3d 1281, 1290 (Fed.Cir.2000), and that under the doctrine of claim differentiation, different claims are presumed to be of different scope. See Inpro II Licensing, S.A.R.L. v. T-Mobile USA, Inc., 450 F.3d 1350, 1353-54 (Fed.Cir.2006).

In proposing that “ ‘[a]ll claims at issue are limited to require surface modification and co-continuous phases,’” (Doc. 94 at 10), J & J first asks the Court find that the term “surface modification” has “the same meaning as surface treatment.” (Docs. 94 at 18; 90-3 at 2.) CIBA responds that “surface modification” is not a term found in any claim in the CIBA patent. J & J relies primarily upon the prosecution history. During the 2000 '100 Patent reexamination proceedings before the USPTO, CIBA inventor Nicolson stated:

24. It is my opinion that we, the inventors, succeeded because:

(a) We discovered the material requirement for a soft silicone hydrogel contact lens to move on the eye, namely, the presence of co-continuous phases of oxyperm and ionoperm material which would provide the high oxygen permeability and ion permeability; and

(b) We discovered the need for surface modification of silicone hydrogels to achieve ophthalmic compatibility of the inner and outer surfaces and that the surface modification had to:

i) accommodate the maintenance of the high oxygen permeability and ion permeability;

ii) provide deposit resistance comfort; and

iii) not perturb the other inherent properties of the lens bulk polymer such as water content, modulus geometry and the like; and

iv) accommodate the shrinkage and/or expansion that can occur during normal processing including hydration, extraction and autoclaving; and use and wear including exposure to care systems....

(Doc. 84-5 at 7 (J & J Ex. 3 ¶24).) In response, the USPTO examiner, in the August 4, 2000 Examiner’s Statement of Reasons for Patentability accompanying the Notice of Intent to Issue Reexamination Certificate, stated among the reasons for determining that all pending objections over the prior art Lai patents were overcome:

It is further observed that, given the patent owner’s position that the instant invention was successful because of the presence of co-continuous phases of oxy-perm and ionoperm materials providing high oxygen and ion permeability and because of the surface modification of the lens material ..., the claims, as presently amended, appropriately reflect this position, explicitly or implicitly.

(Doc. 84-6 at 21 (J & J Ex. 4 at 20).) In addition, J & J cites to specifications which describe the separate oxyperm and iono-perm phases and their characteristics ('100 Patent col. 8 11. 40-60), defining “co-continuous phases” as used in the patent ('100 Patent col. 5 11. 35-39), and stating that “[i]n a particularly preferred embodiment, the lens has two co-continuous phases, one an oxyperm phase, and the other an iono-perm phase....” ('100 Patent col. 8 11. 57-61.)

First, J & J seeks to equate “surface treatment” with “surface modification.” (Doc. 94 at 18.) “Surface treatment process” appears in the claims as part of the phrase “surface modified by a surface treatment process.” As set forth above, the term “surface treatment process” is defined by the patentee in the specification to the patent. J & J equates “modification” with “treatment,” based upon inventor Nicolson’s statement to the USPTO during the reexamination proceedings. J & J’s proposed construction would re-write the claims to read: “surface modified by a surface modification process,” creating a tautology. None of the claims or the specifications use the phrase “surface modification”; rather, the claims provide that the lens surface is modified by a surface treatment process, indicating that the terms “modification” and “treatment” as used in the CIBA patent claims have different meanings. The Court declines to equate and substitute “surface modification” with “surface treatment.” See Purdue Pharma L.P., 438 F.3d at 1136-37 (“[w]ithout any specific claim language to interpret, ... the trial court impermissibly imported a limitation into the claims”). “[Ejxtraneous limitations cannot be read into the claims from the ... prosecution history.” Bayer AG. v. Biovail, Corp., 279 F.3d 1340, 1348 (Fed.Cir.2002) (citations omitted).

The next question is whether the Court should construe all 251 claims set forth by CIBA’s six patents as being limited by the terms “surface modification” and “con-continuous phases,” as proposed by J & J based upon the prosecution history.

J & J argues that the above-cited prosecution history represents a disclaimer by CIBA, relying upon the case Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361 (Fed.Cir.2003), in which the Federal Circuit construed the claims to include a feature that was common to all the disclosed embodiments but was not explicitly recited as a limitation in any of the claims. The Court held that “the specification makes clear at various points that the claimed invention is narrower than the claim language might imply” based upon a reading of the specification as a whole. Id., at 1370.

“When the specification ‘makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question.’ ” Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1347 (Fed.Cir.2004) (citation omitted). “A patentee may also limit the scope of the claims by disclaiming a particular interpretation during prosecution.” Id.

While the Court recognizes that explicit arguments made during prosecution to overcome prior art can lead to narrow claim interpretations, Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1372-73 (Fed.Cir.2005) (citation omitted)(“[w]here an applicant argues that a claim possesses a feature that the prior art does not possess in order to overcome a prior art rejection, the argument may serve to narrow the scope of otherwise broad claim language”), any disclaimer must be clear and unambiguous. Id. at 1373; see also Purdue Pharma L.P., 438 F.3d at 1136 (“[u]n-der the doctrine of prosecution disclaimer, a patentee may limit the meaning of a claim term by making a clear and unmistakable disavowal of scope during prosecution”). Despite the representations and the examiner’s observation, the examiner did not require CIBA to amend all claims to reflect in each and every one the term “surface modification” and “co-continuous phases,” and CIBA did not do so. The Court determines that Dr. Nicolson’s representation to the USPTO examiner did not clearly and unambiguously disclaim and disavow the scope of the CIBA patents’ claims. Further, unlike the patent described in Alloc, the language of the claims and specifications here do not criticize prior art as lacking the proposed limitations, nor do all embodiments contain the limitations, and thus, the claims and specifications are not “sufficiently clear” that all claims are limited by the terms “surface modification” and “co-continuous phases.”

The claims and specifications do not support the narrowing construction proposed by J & J.

3. “Altering the surface of said core material to produce a surface which is more hydrophilic than said core material”

“Altering the surface of said core material to produce a surface which is more hydrophilic than said core material by a surface treatment process”

_J & J’s Proposed Construction_ “Altering the surface of said core material to produce a surface which is more hydrophilic than said core material” and “Altering the surface of said core material to produce a surface which is more hydrophilic than said core material by a surface treatment process” means that a core contact lens material that has a surface be created, and then the surface of that core material is altered by a post-manufacturing surface treatment process. (Doc. 90-3 at 2 (J & J Ex. 101).) CIBA’s Proposed Construction_ [N.D. Ga.] “This term refers to modifying the material such that the exterior or surface of the modified material is more clinically wettable than the material without modification.” (Docs. 86 at 26; 96 at 37 (App. A).) This term refers to modifying the material such that the exterior or surface of the modified material is more clinically wettable than the material without modification by a surface treatment process (as defined above). (Doc. 86 at 40 (App. A); Doc. 91-2 at 11 (Response App. 1).) Altering the surface is not a claim requirement for claims that do not expressly recite this limitation. (Doc. 86 at 37 (App. A); 91-2 at 8 (Response App. 1).) Altering the surface is not limited to post-manufacture modifications for claims that do not expressly recite them. (Doc. 86 at 37 (App. A); 91-2 at 8 (Response App. 1).)

The “altering the surface” language is found in Claims 1, 12 and 14 of the '461 Patent, a method patent. As an example, Claim 1 states:

1. A method of forming a biocompati-ble lens having high oxygen permeability and high water permeability, said method comprising the steps of:

(a) forming a polymeric core material including:

(1) at least one continuous pathway from front curve to base curve surfaces for oxygen transmission there-through, and

(2) at least one continuous pathway from front curve to base curve surfaces for water transmission there-through; and

(b) altering the surface of said core material to produce a surface which is more hydrophilic than said core material,

whereby said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids....

('461 Patent, cl. 1 (emphasis added).)

J & J contends that the language of the claimed method for forming a biocompati-ble contact lens requires that the steps listed in the patent — “forming a polymeric core material” and “altering the surface of said core material” must be performed in “sequential” order because the claim language “implies” that the core material exists before the surface of “said core material” is altered. For this reason, J & J urges that the language be construed to provide that the “core material is altered by a post manufacturing surface treatment process.”

CIBA responds that the “post-manufacturing” limitation pressed by J & J should not be imported into the patent because the plain language of the claims imposes no sequence or order of methods, and that such order is belied by the specifications.

“Unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one.... [Citation omitted.] However, such a result can ensue when the method steps implicitly require that they be performed in the order written.” Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342-43 (Fed.Cir.2001).

The Federal Circuit has offered a two-part test for determining whether the steps of a method claim that do not otherwise recite an order, must nonetheless be performed in the order in which they are written. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1369-70 (Fed.Cir.2003). First, the court is directed to look at the claim language to determine if, as a matter of logic or grammar, they must be performed in the order written. Id. at 1369. If not, the court next looks to the rest of the specification to determine whether it “ ‘directly or implicitly requires such a narrow construction.’” Id. at 1370. If that construction is not applicable, the sequence in which such steps are written is not a requirement. Id. at 1370.

In this case, nothing in the claim or the specification requires such a narrow limiting construction. Looking at the claim language, there is no reason why the formation of the polymer core material and the alteration of the surface of the core material must be consecutive steps; the language of the claim does not exclude the possibility that the two steps occur simultaneously or concurrently. In other words, under the language of the claim, the formation of the core material could conceivably include a process which results in an alteration of the surface of that core material. See Interactive Gift Express, Inc., 256 F.3d at 1343.

The patent specifications do not nullify this possibility. The '461 Patent contains the same specification cited above, defining “surface treatment processes” which includes “[a]nother set of methods of altering the surface properties of a lens involving] treatment prior to polymerization to form the lens” by, for example, treating the lens mold to cause the prepolymerization mixture immediately adjacent to the mold surface to differ in composition from the core. ('461 Patent col. 42 11. 53-68 and col. 43 ll. 1-13.) J & J does not cite any provision in the patent that requires the “altering the surface” step to be performed after the “forming a polymeric core material” step. See Altiris, Inc., 318 F.3d at 1371; see also Bell Communications Research, Inc. v. Fore Systems, Inc., 62 Fed.Appx. 951, 954-56 (Fed.Cir.2003)(nothing in claim’s grammar, precedent, logic, specification or prosecution history dictated that “filling” of “empty payload fields” in patent for telecommunications device could not begin prior to payload fields being completed).

CIBA proposes that the Court adopt the construction set forth by the Northern District of Georgia in the B & L case:

'461 Patent cl. 12 N.D. Ga. (proposed by CIBA) Altering the surface of said core material to produce a surface which is more hydrophilic than said core material by a surface treatment process “This term refers to modifying the material such that the exterior or surface of the modified material is more clinically wettable than the material without modification.” (Docs. 86 at 26 87 (CIBA Ex. G at 10).)_ While observing reasoned deference to the previous claim construction, the Court concludes that the language at issue here needs no further construction. The chief dispute between the parties here is whether the claim contemplates a sequencing of steps in the production of an extended wear opthalmalic lens having a hydrophilic surface. That being resolved, the parties do not dispute the remaining terms. The B & L case construction, which consists of re-phrasing the terms of the claim, introduces more questions and ambiguities than the original claim term. Accordingly, the Court declines to construe the language further. 4. “Region of Substantially Uniform Composition” J & J’s Proposed Construction CIBA’s Proposed Construction region having very near consistency of chem- None proposed. ical composition throughout (Doc. 94 at 20)_

J & J seeks further construction of three phrases found in the patent specification definition and agreed-to construction for the claim term “phase.” As to the first term, J & J’s proposes that the term “region of substantially uniform composition” should be construed to mean “very near consistency of chemical composition.” J & J cites to the Federal Circuit’s treatment of the phrase “substantially uniform” in the case Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358 (Fed.Cir.2001), as support for its proposed construction. CIBA contends that it is entitled to be its own lexicographer and entitled to specify its own definition of claim terms. Thus, according to CIBA, it is not proper for the Court to construe the terms of the explicit patent definition of “phase.” (Tr. 176.)

The parties have not cited any case which addresses whether, as a matter of law, the Court may construe terms which appear in specifications and definitions found in a patent, in addition to the terms found in the claims. Moreover, the Court is not persuaded that CIBA’s definitional use of “substantially uniform composition” for each phase requires further construction. First, a prior construction of the term “substantially” in another case does not dictate a construction here. “A particular term used in one patent need not have the same meaning when used in an entirely separate patent, particularly one involving different technology.... A patentee may define a particular term in a particular way, and in that event the term will be defined in that fashion for purposes of that particular patent, no matter what its meaning is in other contexts.” Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1318 (Fed.Cir.2005). Indeed, “the term ‘substantially’ is a descriptive term commonly used in patent claims to ‘avoid a strict numerical boundary to the specified parameter.’ ” Ecolab, Inc., 264 F.3d at 1367 (citation omitted).

Second, when a patent specification reveals a special definition of a claim term that differs from meaning it would otherwise possess, the inventor’s lexicography governs. Phillips, 415 F.3d at 1316. “However, ‘[t]he patentee’s lexicography must, of course, appear with reasonable clarity, deliberateness, and precision before it can affect the claim.’ ” Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1354 (Fed.Cir.2003); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed.Cir.1998). Here, the parties agreed to the patent lexicographer’s definition of the term “phase.” The accused may not now go back and contend that the agreed-to definition lacks in “reasonable clarity, deliberateness, and precision” and thus should be further construed. Compare Abbott Labs., 334 F.3d at 1355 (where specification provided two alternative definitions for the claim term, specification did not define the term with reasonable clarity, deliberateness and precision).

The Court also notes that J & J attempts to import a further limitation into CIBA’s definition of “phase,” not apparent on the face of the claim or in any cited specification or prosecution history, to the effect that J & J defines “substantially uniform composition” as referring to the phase’s “chemical composition throughout.” Cf. MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1334 (Fed.Cir.2007)(“[l]imiting claims from the specification is generally not permitted absent a clear disclosure that the patentee intended the claims to be limited as shown”).

The Court declines to further construe the phrase: “region of substantially uniform composition.”

5. “Distinct and Physically Separate Portion of a Heterogeneous Polymeric Material”

_J & J’s Proposed Construction_ CIBA’s Proposed Construction portion characterized by an identifiable None proposed. boundary (Doc. 94 at 21)_

The contested phrase: “distinct and physically separate portion of a hetergeneous polymeric material” is found in the agreed-upon construction of “phase.” Arguing that the word “distinct” is different from the term “physically separate,” J & J contends that the phases must be “characterized by an identifiable boundary.” J & J cites to the Merriam-Webster’s Collegiate Dictionary definition of “distinct” to mean “distinguishable to the eye or mind as discrete.” (Doc. 84-87 at 4 (J & J Ex. 82).)

CIBA opposes any additional construction of the term, citing to the '100 Patent specification which describes “distinct phases” in one preferred embodiment as follows:

While there may be two distinct phases, it is believed that there may be a transition phase, or interphase, in which the material composition and the material properties are a blend of those of the oxyperm and ionoperm materials. Thus, there may exist a distinct oxyperm phase or plurality of distinct oxyperm phases, a distinct ionoperm phase or a plurality of distinct ionoperm phases, and an amphipathic phase mixture or blend of oxyperm and ionoperm phases

('100 Patent col. 8 ll. 29-37.) The specification rejects a lens structure “which includes large phase separated regions” as reducing visible light transmission and causing undesirable image distortion. ('100 Patent col. 8 ll. 17-21.)

“While dictionaries may be used to ascertain the plain and ordinary meaning of claim terms, the intrinsic record is used to resolve ambiguity in claim language or, where it is clear, trump inconsistent dictionary definitions.” W.E. Hall Co. v. Atlanta Corrugating, LLC, 370 F.3d 1343, 1350 (Fed.Cir.2004). J & J’s cited dictionary definition speaks of phases with “boundaries” that are “distinguishable to the eye or mind as discrete.” The patent’s specification discusses an “interphase” between the two phases which may more gradually move from one phase to another; the very image described by the patent specification does not necessarily require “identifiable boundaries.”

Accordingly, the Court declines to further construe the phrase: “distinct and physically separate portion of a hetergeneous polymeric material” as suggested by J & J.

6. “Essentially Only Ionoperm Polymer” and “Essentially Only Oxy-perm Polymer”

_J & J’s Proposed Construction_ almost pure ionoperm material with oxyperm material present only as a minor impurity that does not affect the ion, water and oxygen permeability values of pure ionoperm. (Doc. 94 at 20) almost pure oxyperm material with ionoperm material present oxyperm [sic] only as a minor impurity that does not affect the ion, water and oxygen permeability values of pure oxyperm. (Doc. 94 at 20) _CIBA’s Proposed Construction None proposed.

J & J argues that the “essentially only” language in the definition of “phase” provides no guidance to the factfinder as to what level of ionoperm or oxyperm material impurity can be included in a phase such that the phase retains its permeability level. J & J contends that its proposed construction using the terms “almost pure” and “minor impurity” does provide the necessary guidance. According to J & J, “it doesn’t have to be mathematically precise, but there has to be some guidance to the finder of fact on how to decide is this essentially only ionoperm [or oxyperm] or not.” (Tr. 172.) J & J acknowledges that the permeability of a phase need not be equal to that of a pure ionoperm or oxy-perm polymer, but rather “there would have to be some allowance given” on the permeability level differential from pure. (Tr. 167-72.) J & J contends that the additional language is “taught” by the specifications explaining the purpose of the phases. (Tr. at 170.)

CIBA responds that 1) J & J is not entitled to re-write the definitions which CIBA, as its own lexicographer, included in its patent, and 2) J & J’s proposed construction of the definition is contrary to its meaning. CIBA argues that the patent’s definition does not imply that a “phase” is “chemically pure,” but rather defines the differences in the phases “in terms of bulk properties, not in terms of chemical purity.... So long as there’s a significant difference in bulk properties [of the phases], the impurities absolutely can affect the ion water or oxygen permeabilities.” (Tr. at 180.)

Again, J & J is asking the Court to construe a specification definition term. J & J’s proposed definition does nothing to advance the understanding of “essentially only,” which CIBA, acting as its own lexicographer, has set forth with “reasonable clarity, deliberateness, and precision,” when coupled with the rest of the definition of “phase,” to accomplish the purpose of the patent. See Abbott Labs., 334 F.3d at 1354. The Court declines to further construe the phrases.

7. “Phases Substantially Separate”

_J & J’s Proposed Construction_ at least two phases, both physically separate from each other, and each being substantially uniform in composition. (Doc. 90 at 13.) _CIBA’s Proposed Construction_ [N.D. Ga.] “Phases substantially separate” means at least two regions (e.g. an ionoperm region and an oxyperm region), each of substantially uniform composition which differs

[from composition which differs] from the other. However, each “phase” need not be a chemically pure substance, but merely connotes that certain bulk properties differ significantly from the properties of another phase within the material. Thus, with respect to separate or co-continuous oxyperm or ionoperm phases, the 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. 86 at 20-21.)_

The term “phases substantially separate” appears in the '100 Patent claims as follows:

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polym-erizable material

('100 Patent els. 1, 50, 51, 53-57.)

Drawing upon the definition of “phase” contained in the patent specification, ('100 Patent col. 5 11. 20-31), and recognizing that the proposals of both parties regarding the meaning of “substantially separate” simply repeat portions of the definition of “phase,” the Court construes “phases substantially separate” as follows:

“Phases Substantially Separate”

“Phases substantially separate” means at least two “phases” as “phase” is previously defined.

8. “Pathways” and “Continuous Pathways”

_J & J’s Proposed Construction_ a pathway has the same meaning as phase. (Doc. 94 at 22) a phase which forms a continuous structure from one surface of an article to another surface of an article. (Doc. 94 at 22) _CIBA’s Proposed Construction_ [N.D. Ga.] a polymer region that extends from one surface of the lens to the opposite surface of the lens, with a continuous pathway for water transmission manifesting itself in a high water or ion permeability and a continuous pathway for oxygen manifesting itself in a high oxygen permeability, as defined above. (Doc. 86 at 21.)_

The terms “pathways” and “continuous pathways” are found in a number of patent claims. The claim terms are used as follows:

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye ...

('100 Patent els. 1, 44, 49-57, 59, 60 (emphasis added));

11. An ophthalmic lens of claim 1, wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

('100 Patent cl. ll)(emphasis added);

12. An ophthalmic lens of claim 11, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of silox