Court Opinion

ID: 211527
Source: CourtListenerOpinion
Date Created: 2011-03-13 08:28:31+00
Date Added: 2024-06-11T17:28:06.915073
License: Public Domain

NOTE: Pursuant to Fed. Cir. R. 47.6, this disposition is not
            citable as precedent. It is a public record.

United States Court of Appeals for the Federal Circuit

                                      05-1215

      KOEPNICK MEDICAL & EDUCATION RESEARCH FOUNDATION, L.L.C.,

                                              Plaintiff-Appellant,

                                         v.

                         ALCON LABORATORIES, INC.,
                      ALCON REFRACTIVE HORIZONS, INC.,
                      SOUTHWESTERN EYE CENTER, LTD.,

                                              Defendants-Appellees,

                                        and

                       BAUSCH & LOMB INCORPORATED,
                     SWAGEL-WOOTTON EYE CENTER, LTD.,

                                              Defendants-Appellees.

                          __________________________

                          DECIDED: December 28, 2005
                          __________________________

Before LOURIE, Circuit Judge, ARCHER, Senior Circuit Judge, and PROST, Circuit
Judge.

LOURIE, Circuit Judge.

      Koepnick Medical & Education Research Foundation, L.L.C. (“Koepnick”)

appeals from the decision of the District Court for the District of Arizona granting

judgment of noninfringement of U.S. Patent 5,658,303 in favor of Alcon Laboratories,

Alcon RefractiveHorizons, Inc., Southwestern Eye Center, Ltd., Bausch & Lomb and
Swagel-Wootton Eye Center, Ltd. Koepnick Med. & Educ. Research Found., L.L.C. v

Alcon Labs. Inc., No. Civ 03-0029 (D. Ariz. Dec. 28, 2004). Because the district court

properly construed the claim limitation “excising,” and the parties agreed that, under that

claim construction, there was no infringement, we affirm.

                                      BACKGROUND

       The ’303 patent is entitled “Universal Automated Keratectomy Apparatus and

Method,” and was issued to Russell G. Koepnick as inventor. The invention relates to a

surgical method for performing refractive eye surgery.         Refractive eye surgery is a

surgical procedure that alters the curvature of the eye to reduce the amount of refractive

error, which is described and manifested as myopia (nearsightedness), hyperopia

(farsightedness), and/or astigmatism.      Refractive surgery was first performed in the

1960’s using microkeratomes, cutting devices with a knife edge. Id., col. 1, ll. 26-39. In

those early procedures the cut disk was frozen, reshaped with a lathe according to the

patient’s prescription, and sewn back onto the patient’s cornea. Id. Later refinements in

the 1980’s eliminated the need to freeze the disk. Id., col. 1, ll. 39-45. One such

technique, known as keratomileusis in-situ or lamellar keratectomy, involved the

creation of a corneal flap using a microkeratome, and then the removal of a second,

smaller piece of corneal tissue by a second pass of the microkeratome. The original

flap was then replaced on the eye back into its original position. Id., col. 1, ll. 39-45; col.

13, ll. 19-22. The amount of optical correction was controlled by the diameter and

thickness of the second disk. Id., col. 13, ll. 27-29. Another technique for performing

refractive eye surgery was a procedure known as Laser In-Situ Keratomileusis

(“LASIK”), developed in the early 1990’s. In the LASIK procedure, a microkeratome

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was used to cut a lamellar (sides parallel to the corneal surface) flap of tissue that

remains hinged to the eye. With the corneal flap folded back, a laser then “ablate[d]

(remove[d] by vaporization) the cornea in a manner that result[ed] in removing a

lenticular (sides not parallel to the surface of the cornea) disk from the cornea . . . ” Id.,

col. 2, ll. 2-5.

        The ’303 patent is directed to a surgical method involving an improved

microkeratome capable of cutting lamellar and lenticular shaped disks from the eye by

using special inserts that allow the microkeratome to cut disks having different shapes.

Id., col. 3, ll. 1-25. As illustrated in Figures 55e and 55f, a corneal flap is first cut using a

lamellar insert, such that the disk created by the cut remains hinged to the eye.

Next, as illustrated in Figures 55g and 55h, a second lenticular-shaped disk is removed

using a lenticular insert. According to the ’303 patent, it is the removal of this second

disk that provides the prescriptive correction. Id., col. 5, ll. 11-15.

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       On January 8, 2003, Koepnick filed suit against Alcon Laboratories, Alcon

RefractiveHorizons, Inc.,1 Southwestern Eye Center, Ltd., Bausch & Lomb and Swagel-

Wootton Eye Center, Ltd. in the United States District Court for the District of Arizona for

infringement of independent claim 1 and dependent claims 2, 3, 4, 5, and 6 of the ’303

patent.2    The LASIK procedures accused of infringement are performed by

Southwestern Eye Center and Swagel-Wootton Eye Center using equipment supplied

by Alcon Laboratories, Inc., Bausch & Lomb Inc., and/or Alcon RefractiveHorizons, Inc.

Alcon Laboratories, Alcon RefractiveHorizons, Inc., and Southwestern Eye Center, Ltd.,

(collectively “Alcon”) and Bausch & Lomb and Swagel-Wootton Eye Center, Ltd.

(collectively “B&L”) denied Kopenick’s allegations of infringement and counterclaimed

for declaratory relief that the ’303 patent was invalid and not infringed. Additionally,

Alcon counterclaimed for a declaration that the ’303 patent was unenforceable. On

December 7, 2004, after conducting a Markman hearing, the district court construed

certain limitations contained in claims 1-6. Koepnick Med. & Educ. Research Found.,

1
       Koepnick filed its original complaint against Summit Autonomous, Inc. Summit
Autonomous Inc. merged into Alcon RefractiveHorizons, Inc. in July 2003, and was
replaced as defendant by Alcon RefractiveHorizons, Inc.
2
       Claim 1 of the ’303 patent reads as follows:

       A method of performing corrective eye surgery comprising the steps of:
       determining a desired prescriptive correction for a patient’s eye;
       cutting a first disk to remove the epithelium of said eye, said first disk being
formed as a flap;
       excising a second disk from said eye, said second disk being shaped to provide
said desired prescriptive correction; and
       replacing said first disk on said eye.

Id., col. 15, ll. 5-15 (emphasis added). Claims 2-6 depend from claim 1. None of the
dependent claims contains additional limitations that are at issue in this appeal.

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L.L.C. v Alcon Labs. Inc., 347 F. Supp. 2d 731 (D. Ariz. 2004) (“Claim Construction

Order”).

       The court construed the claim limitation “excising” to mean “cutting out” and

“desired prescriptive correction” to mean “a refractive correction sought to reduce a

patient’s refractive error, expressed as in a doctor’s prescription for eyeglasses or

contact lenses.” Id. at 743. In construing the term “excising,” the court determined that

the ordinary and customary meaning of the term is “cutting out,” and that this definition

is consistently used throughout the intrinsic evidence, i.e., the patent specification and

prosecution history. Id. at 741. The court explained that “the claim term ‘excising’

cannot mean ‘removing’ generally so as to encompass removal by laser ablation”

because the written description distinguishes the term “excise” from “ablate.” Id. at 743.

Further, the court observed that the language of the claims does not contemplate a

meaning of “excise” that encompasses “ablation” because it requires a “second disk”

having a particular shape, and ablated tissue that has been vaporized into a gas has no

shape. Id. at 741. The court also reasoned that construing the term “excising” to

encompass “ablation” would render the patent invalid by the wealth of prior art LASIK

procedures and would read out the invention’s “major advantage” of reversibility. Id. at

742.   Finally, the court concluded that Koepnick’s failure to dispute the Patent and

Trademark Office (“PTO”) examiner’s sole stated reason for allowance of the ’303

patent – “that the prior art of record fails to teach or adequately disclose the steps of

cutting two disks from the eye” – supports the construction of the term “excising” to

mean “cutting out.” Id.

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       The district court also construed the term “determining a desired prescriptive

correction” to mean “a refractive correction sought to reduce a patient’s refractive error,

expressed in a doctor’s prescription for eyeglasses or contact lenses.” Id. The court

gave the phrase its ordinary meaning, reasoning that it contained no technical terms of

art and there was no evidence supporting any of Koepnick’s proposed limitations. Id. at

742-43. The court pointed out that the ordinary meaning was supported by the written

description, which clarifies that the claim language simply refers to a doctor’s

prescription. Id.

      Based on the district court’s claim constructions, both parties stipulated to

noninfringement, agreeing that the “accused LASIK procedures remove tissue by laser

ablation and do not meet the ‘excising’ limitation as construed by the Court, either

literally or under the doctrine of equivalents.” Koepnick Med. & Educ. Research Found.,

L.L.C. v Alcon Labs. Inc., No. Civ 03-0029 (D. Ariz. Dec. 21, 2004). The court entered

final judgment of noninfringement on December 28, 2004, and Koepnick timely

appealed to this court. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

                                      DISCUSSION

       Claim construction is an issue of law, Markman v. Westview Instruments, Inc., 52

F.3d 967, 970-71 (Fed. Cir. 1995) (en banc), that we review de novo, Cybor Corp. v.

FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc).

      On appeal, Koepnick argues that the district court’s decision was based on an

erroneous construction of the claim limitation “excising.” According to Koepnick, by

interpreting “excising” to mean “cutting out” rather than “removing tissue,” the court

failed to give the contested term its ordinary meaning, as defined in dictionaries and

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relevant patents and articles. Koepnick also contends that because the claims contain

both the words “cutting” and “excising,” they should be presumed to mean different

things. Koepnick argues that the ordinary meaning of the term “excising” encompasses

non-cutting mechanical techniques such as laser ablation and the court unduly

narrowed the scope of the claims by importing the word “intact” from the specification

into the element “excising a second disk” and relying on the statement in the

specification that one advantage of the invention was “reversibility.”      Koepnick also

maintains that its failure to dispute the PTO examiner’s statement during prosecution

that the invention relates to “cutting” two disks from the eye could not have restricted the

scope of the claims because the statement was not directed to any specific claim or the

scope of the claims. Finally, Koepnick argues that the failure of the ’303 patent to

describe how to use a laser to remove corneal tissue in a mathematically precise way to

achieve emmetropia should not preclude recovery because, at the time the patent

issued, the use of lasers in refractive eye surgery, although disclosed in the prior art,

had not yet been perfected.

      Alcon and B&L respond by essentially repeating the analysis contained in the

district court’s Claim Construction Order. Alcon and B&L assert that the claim language

and specification consistently use “excising” to mean “cutting out,” and the prosecution

history confirms that understanding because the PTO examiner recognized that the

invention required cutting the second disk. Alcon and B&L also note that the ’303

patent specification contrasts “excising” with removal by laser “ablation” and

distinguishes LASIK procedures as prior art. According to Alcon and B&L, the written

description and drawings require the “excised” second disk to have a specific shape,

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which does not occur when eye tissue is removed by laser ablation. Alcon and B&L

point out that the “Summary of the Invention” section supports this interpretation

because it touts “reversibility” as one of the invention’s many advantages over LASIK

procedures. Finally, Alcon and B&L argue that the claim limitation “excising” cannot be

read to encompass future improvements that were not possible when the ’303 patent

was filed, such as accurate removal of eye tissue with laser ablation.

      We agree with Alcon and B&L that the district court properly construed the claim

limitation “excising” to mean “cutting out.” Our primary focus in determining the ordinary

and customary meaning of a claim term is to consider the intrinsic evidence of record,

viz., the patent itself, including the claims, the specification and, if in evidence, the

prosecution history, from the perspective of one of ordinary skill in the art. Phillips v.

AWH Corp., 415 F.3d 1303, 1312-17 (Fed. Cir. 2005) (en banc). Here, the construction

of “excising” that is consistent with the claims, specification, and prosecution history is

“cutting out,” and thus we give the claim limitation that ordinary and customary meaning.

      We begin with the language of the claims. Claim 1 requires “excising a second

disk, said second disk being shaped to provide said prescriptive correction.”         ’303

patent, col. 15, ll. 13-15. Claim 6 further requires that the second disk must have a

“positive or negative meniscus shape.” Id. at col. 15, ll. 28-30. Because the claims

make clear that the excised second disk has a defined shape, the scope of what

constitutes “excising” is expressly limited to surgical techniques that create such a

defined shape.    Koepnick urges a construction of “excising” as “removing tissue.”

However, that interpretation is inconsistent with the requirements of the claim because it

would encompass methods in which the “excised” tissue does not have a defined

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shape, such as laser ablation. As the district court correctly observed, “‘[a]blating’ with

a laser cannot fall within the scope of the claim because ablated tissue has been

vaporized into a gas, and therefore, has no shape.” Id. The claim therefore requires a

construction of “excising” that excludes laser ablation.

       The specification supports that interpretation of “excising” as “cutting out.” The

term “excising” is unambiguously used to mean cutting with a knife blade in both the

“Abstract” and “Summary of the Invention” sections. ’303 patent, Abstract; col. 2, ll. 31-

32. Further, every embodiment disclosed in the patent uses a knife edge to make a cut

in the cornea. There is no evidence supporting Koepnick’s assertion that “excising” also

refers to laser ablation. Indeed, the specification makes clear that LASIK procedures

are an existing surgical technique, i.e., that they are not the invention. The written

description repeatedly distinguishes the invention from procedures involving lasers. Id.,

col. 2, ll. 1-4; col. 13, ll. 9-17.   The “Detailed Description” section also contrasts

“excising” with laser “ablation,” noting that, in the prior art LASIK procedures, a disk is

first “excised” before a laser is used to “ablate” the second disk of tissue from the eye.

Id., col. 13, ll. 9-17.

       Moreover, the “Summary of the Invention” section explains that the “invention has

many advantages over mechanical keratomes, radial lasers and radial keratectomy.

One major advantage is that surgery utilizing the device is reversible . . . by simply

replacing the [second] excised corneal disk or by excising another disk from a donor

cornea using the same insert as used for the original operation.” ’303 patent, col. 2, ll.

53-60 (emphasis added). Although a disk of tissue cut with a knife edge can be put

back onto the eye as described in the specification, a disk of tissue that is vaporized by

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laser ablation cannot be replaced as contemplated in the specification. We conclude

therefore that the specification does not support Kopenick’s proposed construction of

“excising” as encompassing laser ablation.

      The prosecution history further confirms the district court’s construction of

“excising” as “cutting out.” The PTO examiner asserted in the Notice of Allowance of

the ’303 patent that “the primary reason for allowance is that the prior art of record fails

to teach or adequately disclose the steps of cutting two disks from the eye.” J.A. at

3246 (emphasis added). Koepnick did not challenge the examiner’s characterization of

its invention. Indeed, Koepnick concedes that at the time of filing, the inventor did not

believe that claim 1 encompassed LASIK procedures. Appellant’s Br. at 29 (explaining

that “[l]asers in 1995 could not remove corneal tissue in a mathematically precise way to

achieve emmetropia.”). Consistent with that understanding, the claims do not describe

a surgical method of refractive eye surgery using lasers. Indeed, Koepnick disclaimed

the only claim directed to LASIK procedures, claim 13,3 by filing a statutory disclaimer in

the PTO on July 22, 2003. Although we find the timing of the disclaimer on the eve of

3
       Independent claim 13 reads as follows:

       A method of performing refractive surgery comprising the steps of:
       placing a keratome device on an eye, said keratome device having an element
with surface portion recess the depth epithelium of said eye;
       operating said keratome device such that vacuum is applied to said eye urging
said eye into contact with said recess;
       operating said keratome device in an automatic mode such that a knife edge
traverses said element to excise a flap, said knife edge being stopped before said flap is
severed;
       removing said keratome device;
       utilizing a laser to remove corneal tissue to produce a prescriptive correction; and
       replacing said flap.

’303 patent, col. 16, ll. 41-56 (emphasis added).

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the lawsuit to be interesting, to say the least, we express no opinion as to the reason

why Koepnick decided to disclaim claim 13, and whether it was related to issues of

patentability or validity. Irrespective of the reasons for the disclaimer, the result of the

disclaimer is to strip the claims of any reference to lasers, even though the technology

was discussed elsewhere in the specification.4 We therefore conclude that the claim

language, specification, and prosecution history support a construction of “excising” as

“cutting out.”

       Finally, Koepnick argues that the district court erred in not considering extrinsic

evidence in construing the claims. As we discussed in Phillips, “extrinsic evidence may

be useful to the court, but it is unlikely to result in a reliable interpretation of patent claim

scope unless considered in the context of the intrinsic evidence.” 415 F.3d at 1319.

We recognize that our decision in Phillips had not yet issued at the time the district court

rendered its claim construction order and the parties submitted their appellate briefs.

Nevertheless, the district court displayed considerable prescience in its analysis,

correctly noting that because the intrinsic evidence was sufficient to support the claim

construction, it was not necessary to consider extrinsic evidence, such as expert

testimony, inventor testimony, and technical treatises and articles. Claim Construction

Order, 347 F. Supp. 2d at 741, n.3. Accordingly, the dictionary definitions put forth by

Koepnick do not compel a different construction of “excising.”

4
       We have not yet addressed the issue whether a statutory disclaimer filed after
the patent was issued is considered as part of the prosecution history during claim
construction, and whether that statutory disclaimer may operate during claim
construction to preclude a patentee from recapturing subject matter it has surrendered
in certain instances. We will not decide that issue here because it is otherwise clear
from the claims, specification, and prosecution history that the ordinary and customary
meaning of “excising” does not encompass laser ablation.

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      Because we conclude that the term “excising” does not encompass removal by

laser ablation, Koepnick’s appeal of the district court’s claim construction of the phrase

“desired prescriptive correction” is moot.

                                      CONCLUSION

       We affirm the decision of the district court granting judgment of noninfringement

of the ’303 patent in favor of Alcon and B&L.

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