Koepnick Medical & Education Research Foundation, L.L.C. v. Alcon Laboratories, Inc. , 162 F. App'x 967 ( 2005 )

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.05-1215 5
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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