SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
November 29, 2000
-----------------
Date of Report (Date of earliest event reported)
ST. JUDE MEDICAL, INC.
----------------------
(Exact name of registrant as specified in its charter)
Minnesota 0-8672 41-1276891
--------- --------- ----------
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
One Lillehei Plaza, St. Paul, MN 55117
-------------------------------- -----
(Address of principal executive offices) (Zip Code)
(651) 483-2000
--------------
Registrant's telephone number including area code
Not applicable
--------------
Former name or former address, if changed since last report
Page 1 of 4
<PAGE>
ITEM 5. OTHER EVENTS
RECENT DEVELOPMENT IN GUIDANT LITIGATION
On November 29, 2000, the U.S. District Court in Indianapolis issued a decision
interpreting certain ambiguous terms used in the patents which are the subject
of litigation between Guidant and St. Jude Medical. (A copy is attached as
Exhibit 1). The Court's decision gives definitions that will be used at the
trial scheduled for June 2001. A further hearing on disputed terms in the '191
patent that the Court has not interpreted has been set for December 14.
Markman Ruling This being a Markman ruling, the decision issued by the Court
does not discuss whether the patents would apply to any of SJM's products and
does not interpret whether the patents are valid.
In its ruling, the Court adopted some of the interpretation of the patent claims
at issue proposed by the Company, and in other instances adopted interpretations
of the claims proposed by Guidant. The decision discusses a particular validity
issue that applies to two of the patents and states that this remains to be
determined at a future date. We remain confident in light of the Court's
interpretation that SJM's defenses will be upheld, on the basis of
non-infringement as well as invalidity.
Comments About Particular Patents St. Jude Medical contended that the '472 and
'191 patents are limited to atrial devices because that was the only type of
device described throughout the patent. The Court did not agree with St. Jude's
position on this issue. Under the court's ruling, however, the Company continues
to believe that its products do not infringe the '472 and '191 patents asserted
by Guidant in the litigation. Moreover, as recognized by the Court, Guidant will
have to defend the validity of these patents as applying to ventricular as well
as atrial devices. For example, SJM will continue to contend that the patents
are invalid because they do not teach or explain how to build an automatic
device that successfully operates to treat ventricular arrhythmias.
With regard to the '191, patent the Court has asked both parties to further
brief and argue one specific claim interpretation.
The Court adopted SJM's contention that the claims at issue in the '288 patent
must be interpreted to require use of a PDF (Probability Density Function) means
or its equivalent for detecting the heart's condition. The SJM products that
Guidant has claimed in the litigation infringe the '288 patent have never used a
PDF means. The Company will also argue that the design approach in its products
is not equivalent to use of PDF means.
Following is a description of the Guidant litigation.
Guidant's Claims Against SJM On November 26, 1996, Guidant Corporation (a
competitor of Pacesetter and Ventritex) ("Guidant") and related parties filed a
lawsuit against St. Jude Medical, Inc. ("St. Jude Medical"), Pacesetter, Inc.
("Pacesetter"), Ventritex, Inc. ("Ventritex") and certain
Page 2 of 4
<PAGE>
members of the Telectronics Group in State Superior Court in Marion County,
Indiana (the "Telectronics Action"). The lawsuit alleges, among other things,
that, pursuant to an agreement entered into in 1993, certain Guidant parties
granted Ventritex intellectual property licenses relating to cardiac stimulation
devices, and that such licenses would terminate upon the consummation of the
merger of Ventritex into Pacesetter (the "Merger"). The lawsuit further alleges
that, pursuant to an agreement entered into in 1994 (the "Telectronics
Agreement"), certain Guidant parties granted the Telectronics Group intellectual
property licenses relating to cardiac stimulation devices. The lawsuit seeks
declaratory and injunctive relief, among other things, to prevent and invalidate
the transfer of the Telectronics Agreement to Pacesetter in connection with
Pacesetter's acquisition of Telectronics' assets (the "Telectronics
Acquisition") and the application of license rights granted under the
Telectronics Agreement to the manufacture and sale by Pacesetter of Ventritex's
products following the consummation of the Merger. The court overseeing this
case issued a stay of this matter in July 1998 so that the issues could be
addressed in an arbitration requested by the Telectronics Group and Pacesetter.
Guidant and related parties also filed suit against St. Jude Medical, Pacesetter
and Ventritex on November 26, 1996 in the United States District Court for the
Southern District of Indiana. This second lawsuit seeks (i) a declaratory
judgment that Pacesetter's manufacture, use or sale of cardiac stimulation
devices of the type or similar to the type which Ventritex manufactured and sold
at the time the Guidant parties filed their complaint would, upon consummation
of the Merger, be unlicensed and constitute an infringement of patent rights
owned by certain Guidant parties, (ii) to enjoin the manufacture, use or sale by
St. Jude Medical, Pacesetter or Ventritex of cardiac stimulation devices of the
type which Ventritex manufactured at the time the Guidant parties filed their
complaint, and (iii) certain damages and costs. This second lawsuit was stayed
by the court in July 1998 given the order to arbitrate as discussed below.
St. Jude Medical believes that the foregoing state and federal court complaints
contain a number of significant factual inaccuracies concerning the Telectronics
Acquisition and the terms and effects of the various intellectual property
license agreements referred to in such complaints. For these reasons and others,
St. Jude Medical believes that the allegations set forth in the complaints are
without merit. St. Jude Medical has vigorously defended its interests in these
cases, and will continue to do so.
Order to Arbitrate As a result of the state and federal lawsuits brought by
Guidant and related parties, the Telectronics Group and Pacesetter filed a
lawsuit in the United States District Court for the District of Minnesota
seeking (i) a declaratory judgment that the Guidant parties' claims, as
reflected in the Telectronics Action, are subject to arbitration pursuant to the
arbitration provisions of the Telectronics Agreement, (ii) an order that the
defendants arbitrate their claims against the Telectronics Group and Pacesetter
in accordance with the arbitration provisions of the Telectronics Agreement,
(iii) to enjoin the defendants preliminarily and permanently from litigating
their dispute with the Telectronics Group and Pacesetter in any other forum, and
(iv) certain costs. After the Eighth Circuit Court of Appeals ruled on an appeal
in favor of the Telectronics Group and Pacesetter in May 1998, the United States
District Court for the District of Minnesota issued an order on July 8, 1998
directing the arbitration requested by the Telectronics Group and Pacesetter to
proceed.
Page 3 of 4
<PAGE>
Status of Arbitration The arbitrator selected for the arbitration initially
ruled that Pacesetter and St. Jude Medical should not participate in the
arbitration proceeding which would determine whether the Telectronics Agreement
transferred to Pacesetter. Based on this ruling, the Telectronics Group and the
Guidant parties were the ones participating in the arbitration proceeding. This
proceeding occurred in late April 2000, and, on July 10, 2000, the arbitrator
issued a ruling that the attempted assignment and transfer of patent licenses in
the Telectronics Agreement by the Telectronics Group to Pacesetter was
ineffective. As a result of this decision, the Guidant parties filed papers with
the U.S. District Court for the Southern District of Indiana seeking to lift the
stay of the patent infringement court proceedings in that court which had been
entered in June 1998. The court granted Guidant's request to lift the stay and
this matter is scheduled for trial in June 2001.
Background Concerning Patents Involved In Guidant's Claims In the patent
infringement case in federal court in Indiana, the Guidant parties asserted
claims against St. Jude Medical and its Pacesetter subsidiary involving four
separate patents. One of these patents expired May 3, 1998. The '472 patent
expires March 7, 2001, the '191 patent expires on February 25, 2003 and the '288
patent expires on December 22, 2003, although St. Jude Medical has claims in the
court action which, if upheld, would cause the patents to expire earlier, if
they apply at all. Although Guidant has requested injunctive relief and damages
as part of the federal court lawsuit in Indiana, the request for an injunction
would be barred for any expired patent. Guidant is seeking damages for the time
period prior to expiration of the patents.
St. Jude Medical continues to believe that the patent infringement claims raised
by the Guidant parties in the patent infringement case are without merit, and
will continue to vigorously defend its interests in these cases.
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ST. JUDE MEDICAL, INC.
Date: November 30, 2000 By: /s/ John C. Heinmiller
----------------------
John C. Heinmiller
Vice President - Finance
and Chief Financial Officer
Page 4 of 4
<PAGE>
EXHIBIT 1
---------
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
CARDIAC PACEMAKERS, INC., et al., )
)
Plaintiffs, )
)
v. ) CAUSE NO. IP 96-1718-C H/G
)
ST. JUDE MEDICAL, INC., et al., )
)
Defendants. )
ENTRY ON CLAIM CONSTRUCTION ISSUES
INTRODUCTION
Plaintiffs Cardiac Pacemakers, Inc. ("CPI"), Guidant Sales Corporation,
and Eli Lilly and Company allege that defendants St. Jude Medical, Inc.,
Pacesetter, Inc., and Ventritex, Inc. have infringed three patents for medical
devices and methods used to evaluate and treat abnormal conditions in a
patient's heart. The three patents in suit are United States Patent No.
4,316,472 (issued Feb. 23, 1982), No. 4,572,191 (issued Feb. 25, 1986), and No.
4,407,288 (issued Oct. 4, 1983). All three patents address an implantable
cardiac stimulator that delivers electrical shocks to return a heart to its
normal rhythm if it is beating too quickly, too slowly, or erratically. The
implantable cardiac stimulation devices are referred to variously as
"pacemakers," "cardioverters," or "defibrillators" depending on the exact
functions performed by the particular device.
To prevail in this action, plaintiffs must prove that the defendants
have infringed their patents. Patent infringement occurs when a device or method
that is literally covered by the claims
<PAGE>
(or is equivalent to the claimed subject matter) is made, used, or sold without
authorization of the patent holder during the term of the patent. See 35
U.S.C. ss. 271; MULTIFORM DESICCANTS, INC. V. MEDZAM, LTD., 133 F.3d 1473, 1476
(Fed. Cir. 1998).
The claims in a patent are "concise statements of the subject matter
for which the statutory right to exclude is secured by the grant of the patent."
133 F.3d at 1476. Thus, the specific claims that appear in the patent establish
the scope of the protection offered by the patent laws. Where the language used
in the claims is ambiguous, it may become necessary for a court to interpret the
meaning of the claims. It is the court's role, and the purpose of this Entry, to
interpret the disputed language used in the claims of the '472, '191, and '288
patents.
BACKGROUND
Plaintiff CPI owns the three patents in suit and has brought this
infringement action against the three defendants. Guidant Sales Corporation and
Eli Lilly and Company also claim an interest in the patents. The court refers to
the plaintiffs collectively as "CPI" and to the defendants collectively as "St.
Jude."(1)
To begin at the beginning with the claimed inventions, the human heart
is a muscular pump consisting of four chambers: the left atrium and the right
atrium, and the left and right ventricles.
-----------------------
(1)Plaintiffs have also named "John Does" 1 through 10 as defendants,
but that action has no legal significance or effect.
-2-
<PAGE>
The pumping action of the heart results when the heart muscle tissue contracts,
which is caused by electrical stimulation. Arrhythmias are heart diseases which
result from disturbances in the natural electrical conduction mechanism of the
heart. Three broad classes of arrhythmias are relevant here: (1) bradycardia,
where the heart tends to beat too slowly all or part of the time; (2)
tachycardia, where the heart beats too quickly all or part of the time, and (3)
fibrillation, where the heart beats in an erratic, disorganized, or quivering
fashion. See generally Kadish Decl. at P. P. 3-11 (defense expert providing
background on heart structure and heart disease).
An arrhythmia can affect either the atria or the ventricles. It is
important not only to distinguish among the three types of arrhythmia, but also
to identify the location of the arrhythmia. Ventricular fibrillation, for
example, poses an immediate threat to a patient's life. Atrial fibrillation may
need medical attention, but it is not such a great and immediate threat. A
therapy intended for treating ventricular fibrillation must account for the fact
that a patient experiencing ventricular fibrillation loses consciousness in a
matter of seconds. See ID.
The patents in suit cover various devices and methods for detecting and
treating various arrhythmias using an implantable cardiac stimulator. A given
device may treat only a single type of arrhythmia, or it may be capable of
treating multiple types of arrhythmia. To be effective, the device must be
capable of delivering the proper electrical therapy to the right location in the
heart at the right time. Further discussion of both the structures of the
devices and the processes for treating cardiac arrhythmias follows in the
discussion of the particular claim construction issues.
-3-
<PAGE>
PATENT CLAIM CONSTRUCTION
I. CLAIM CONSTRUCTION STANDARDS
The parties have called upon the court to interpret arguable (or at
least argued) ambiguities in some of the patent claims at issue. The court must
construe the terms in the patent as a matter of law. MARKMAN V. WESTVIEW
INSTRUMENTS, INC., 52 F.3d 967, 979 (Fed. Cir. 1995) (EN BANC), AFF'D, 517 U.S.
370 (1996). In MARKMAN the Supreme Court explained that the "construction of
written instruments is one of those things that judges often do and are likely
to do better than jurors unburdened by training in exegesis." 517 U.S. at 388.
The interpretation process does not involve questions of infringement.
Construing the claims of a patent is closely akin to construing other
written documents like contracts or statutes. Some special considerations apply,
however, based on the public's interest in the patent system and the need for
other inventors to know as precisely as possible the scope of a patentee's
claimed invention. Thus, in MARKMAN the Federal Circuit emphasized the need to
focus on publicly available documents in construing patent claims. 52 F.3d at
978-79, 987. In interpreting an asserted claim, "the court should look first to
the intrinsic evidence of record, i.e., the patent itself, including the claims,
the specification and, if in evidence, the prosecution history." VITRONICS CORP.
V. CONCEPTRONIC, INC., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
In considering the intrinsic evidence, the court must first look to the
words of the claims themselves. These words are "generally given their ordinary
and customary meaning." ID. The words "in a patent claim are construed as they
would be understood by a reader skilled in the
-4-
<PAGE>
relevant art unless it appears that the inventor used the words differently."
COLE V. KIMBERLY-CLARK CORP., 102 F.3d 524, 531 (Fed. Cir. 1996). The patentee
may use words in any manner he or she wishes in defining the invention as long
as any special definitions are clear in the patent specification. VITRONICS, 90
F.3d at 1582.
In addition to the language of the claims themselves, the Federal
Circuit has stressed the importance of using the patent specification in
defining the terms in claims: "the 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. The court may also consider
the prosecution history of the patent, in which the applicant may have made
specific statements about the scope of claims in dispute. ID. Both the
specification and the prosecution history are forms of intrinsic evidence.
"Extrinsic evidence is that evidence which is external to the patent
and file history, such as expert testimony, inventor testimony, dictionaries,
and technical treatises and articles." ID. at 1584. Courts should not rely on
extrinsic evidence in claim construction to contradict the meaning of claims
discernible from thoughtful examination of the claims. However, courts are not
prohibited from examining extrinsic evidence even in cases where the patent is
itself clear. PITNEY BOWES, INC. V. HEWLETT-PACKARD CO., 182 F.3d 1298, 1308
(Fed. Cir. 1999). As the Federal Circuit has explained:
[I]t is entirely appropriate, perhaps even preferable, for a
court to consult trustworthy extrinsic evidence to ensure
that the claim construction it is tending to from the patent
file is not inconsistent with clearly expressed, plainly
apposite, and widely held understandings in the pertinent
technical field.
-5-
<PAGE>
ID. at 1309.
The parties here have asked the court to construe twenty-five phrases
used in the disputed patent claims. Several of the phrases overlap with one
another, so resolving the meaning of the language in one claim will often
resolve the same issues as presented in another claim. Having considered the
claim language, the specification of each patent, the documents from prosecution
histories, other exhibits, and the parties' briefs and oral arguments from the
MARKMAN hearing, the court provides the following claim construction, which the
court intends to provide to the jury in its instructions.(2)
II. CLAIM CONSTRUCTION OF THE '472 PATENT
In general, the '472 patent describes an implantable cardioverting
device for the treatment of high rate arrhythmias such as atrial fibrillation,
flutter, or tachycardia. During those times when the patient is suffering such
an arrhythmia and cardioversion is in order, a command given by the patient or
the patient's physician brings the invented device out of its standby condition
to administer a pulse of energy directly to the heart. '472 Patent, col. 1, LL.
46-59.
-----------------------
(2)This entry does not resolve the parties' dispute over the meaning of
the "third monitoring means" element of Claim 1 of the '191 patent. By separate
order today, the court is setting a hearing for further argument on that
element.
-6-
<PAGE>
The patent specification discloses two embodiments of the claimed
invention. The first embodiment is designed for operation by a physician. From
an external console, the physician programs the desired level of cardioverting
energy. Then both the power to charge the device and a set of control signals
are transmitted through the skin of the patient and into the implanted unit. The
invention contemplates that the timing of the release of the charge can be
synchronized with the QRS complex.(3) The physician-operated embodiment includes
a display unit that allows the physician to monitor the patient's
electrocardiograph (ECG) signals. '472 Patent, col. 1, L. 60 to col. 2, L. 12;
Figs. 1 & 2.
The second embodiment allows the patient to cardiovert his or her heart
without the intervention of a physician. The patient is taught to recognize the
symptoms of a cardiovertible arrhythmia and then accomplishes cardioversion when
appropriate by placing a magnet over the skin close to the implanted device. The
magnet closes a switch that initiates the electrical discharge cycle. By leaving
the magnet in place over the skin, the patient can deliver the cardioverting
shocks in sequentially increasing energy levels. Thus, if low energy level
cardioversion does not correct the arrhythmia, the patient leaves the magnet in
place to trigger cardioversion at higher energy levels. In this embodiment, the
energy source - a battery - is incorporated directly into the implanted
cardioverting device. Because there is an implanted battery, energy need not be
transmitted through the skin at the time of cardioversion. Like the
physician-operated embodiment, the patient-operated
-----------------------
(3)The QRS complex (also known as the R-Wave) is a particular point in
the heart's ventricular cycle that can be observed by tracking the
electrocardiograph (ECG) signal. See Pl. Br. at 5. Timing the delivery of a
shock to the atrium to occur right after the QRS complex will prevent the shock
from inducing (fatal) ventricular fibrillation. See Def. Br. at 38-39.
-7-
<PAGE>
embodiment can be equipped with circuitry for synchronizing the cardioverting
shocks with the QRS complex. '472 Patent, col. 2, LL. 13-58; Fig. 3.
The parties dispute the meaning of language used in both Claim 1 and
Claim 18 of the '472 patent. Claim 1 is an apparatus claim, which states:
1. In a cardioverting device, comprising:
storage means for storing energy to convert an abnormal
cardiac rhythm to normal sinus rhythm,
delivery electrode means for discharging the stored energy
into the heart of a wearer of the device, and
switch means for controlling the discharge of the stored
energy into the heart of the wearer;
said device further comprising:
charging means for delivering to said storage means said
energy to convert said abnormal cardiac rhythm,
determining means for determining when the stored energy has
reached a predetermined magnitude for converting said abnormal
cardiac rhythm, and
initiating means for initiating the discharge of converting
energy into the heart of the wearer after the stored energy
has reached said predetermined magnitude;
the improvement wherein said device is an implantable externally
programmable cardioverting device, and includes receiving means for
receiving commands from external to the skin of the wearer of the
device, said programming commands designating a predetermined magnitude
of stored energy for converting said abnormal cardiac rhythm, said
device also including selecting means responsive to said programming
commands received by said receiving means for selecting said
predetermined magnitude, from among a plurality of selectable
magnitudes, of stored energy, for converting said abnormal cardiac
rhythm.
'472 Patent, col. 8, L. 64 to col. 9, L. 26.
-8-
<PAGE>
A. '472 CLAIM 1: "CARDIOVERTING DEVICE"
The principal dispute over the term "cardioverting device" in Claim 1
of the '472 patent is whether the term is limited to atrial cardioverting
devices, as St. Jude contends, or whether the term includes both ventricular and
atrial devices, as CPI argues. The court agrees with CPI that the term
"cardioverting device" as used in the claim without limitation includes both
atrial and ventricular devices.
The claim construction process begins with the claim language itself.
As a starting point, the court gives claim terms their ordinary and accustomed
meaning as understood by one of ordinary skill in the field of invention.
HOCKERSON-HALBERSTADT, INC. V. AVIA GROUP INT'L, INC., 222 F.3d 951, 955 (Fed.
Cir. 2000). Neither Claim 1 of the '472 patent nor any of the other '472 claims
uses the word "atrium" or "atrial." Looking exclusively at the claim itself,
there is no basis for adding the limiting adjective "atrial" to the construction
of the more general term "cardioverting device."(4)
-----------------------
(4)The parties have submitted extrinsic evidence on this issue, with
experts in the field arguing that the term "cardioverting device" in the '472
patent claims either is or is not limited to atrial devices. See PITNEY BOWES,
INC. V. HEWLETT-PACKARD CO., 182 F.3d at 1309 (stating that it is appropriate to
consult extrinsic evidence to ensure that the court's construction of technical
terms is not inconsistent with the widely held understandings in the pertinent
technical field). However, even the defense experts do not claim that one
skilled in the art would ordinarily understand the term "cardioverting device,"
UNLESS OTHERWISE QUALIFIED, as limited to only atrial devices. The defense
experts instead argue from other intrinsic evidence that the term should be
given the limited reading when it is read in context in the '472 patent. See
Kadish Decl. P. 12 (opining that "in the context of the '472 patent," the term
"cardioverting device" describes atrial cardioverters, but not suggesting in any
way that the term is generally understood to be so limited); Kroll Rebuttal
Decl. P. 6 (opining that the claim should be understood to cover only atrial
devices because "the entire specification of the '472 patent is directed solely
to atrial devices").
-9-
<PAGE>
The claim term's ordinary and accustomed meaning in the art, however,
serves initially only as a default meaning. The Federal Circuit has explained:
[T]he patentee may act as a lexicographer and ascribe a
different, or modified, meaning to the term. SEE MULTIFORM
DESICCANTS, INC. V. MEDZAM, LTD., 133 F.3d 1473, 1477, 45
USPQ2d 1429, 1432 (Fed. Cir. 1998) (observing that an
inventor, acting as a lexicographer, may bestow "a special
meaning to a term in order to convey a character or property
or nuance relevant to the particular invention");
INTELLICALL, INC. V. PHONOMETRICS, INC., 952 F.2d 1384, 1388,
21 USPQ2d 1383, 1386 [(Fed. Cir. 1992)]. The court,
therefore, must examine a patent's specification and
prosecution history to determine whether the patentee has
given the term an unconventional meaning. SEE VITRONICS, 90
F.3d at 1582, 39 USPQ2d at 1577 (holding that "it IS ALWAYS
necessary to review the specification to determine whether
the inventor has used any terms in a manner inconsistent with
their ordinary meaning [because the specification] acts as a
dictionary when it expressly defines terms . . . or when it
defines terms by implication" (emphasis added)); SOUTHWALL
TECHS., INC. V. CARDINAL IG CO., 54 F.3d 1570, 1576, 34
USPQ2d 1673, 1676 (Fed. Cir. 1995) (determining that
"[a]rguments and amendments made during the prosecution of a
patent application . . . as well as the specification and
other claims MUST be examined to determine the meaning of
terms in a claim" (emphasis added)). If the patentee has not
done so, the term's ordinary and accustomed meaning controls.
SEE YORK PRODS., INC. V. CENTRAL TRACTOR FARM FAMILY CTR., 99
F.3d 1568, 1572, 40 USPQ2d 1619, 1622 (Fed. Cir. 1996)
("Without an express intent to impart a novel meaning to
claim terms, an inventor's claim terms take on their ordinary
meaning.").
ID. Under these rules of claim construction, the court must examine the
specification and the prosecution history to determine whether the patentee
explicitly or implicitly defined "cardioverting device" to refer only to atrial
devices.
The specification does not explicitly limit the phrase "cardioverting
device" to atrial devices. St. Jude argues that the '472 patent specification
nevertheless at least implicitly defines the term "cardioverting device" to
include only atrial devices. There are several examples of potentially limiting
language in the written description of the '472 patent. For example, the
Abstract describes "An externally controlled implantable electronic device for
delivering a cardioverting pulse of
-10-
<PAGE>
energy to the atrium of an ailing heart." The specification also states that the
invention "relates to an atrial device designed to be implanted under the skin
of patients who frequently suffer from bouts of atrial fibrillation, flutter or
tachycardia," '472 Patent, col. 1, LL. 46-49; that "it is one object of the
present invention to provide a device which will enable to [sic] cardioversion
of a heart undergoing atrial fibrillation, flutter or tachycardia, without
hospitalization," '472 Patent, col. 2, LL. 59-62; that "Yet another object of
the present invention is to provide a method for cardioverting a heart suffering
from an atrial malfunctioning, wherein cardioversion is initiated by a physician
or by the wearer while in a state of consciousness," '472 Patent, col. 3, LL.
18-22; and "Now, with reference to FIG. 3, the totally implantable embodiment of
the invention elective atrial device will be described." '472 Patent, col. 7,
LL. 3-5.
Beyond the repeated use of the words "atrial" and "atrium" in the
specification, there is no doubt that the two disclosed embodiments (shown in
Figures 1 through 3 and discussed in detail in the specification) are designed
to treat only atrial arrhythmias. The specification does not describe an
embodiment of the invention that is designed to function as a ventricular
defibrillator.
There is obviously some tension between the narrower '472 specification
language and the broader '472 claim language. The Federal Circuit, however, has
repeatedly cautioned against limiting the scope of a claim to a preferred
embodiment or to specific examples disclosed in the specification. See, e.g.,
EKCHIAN V. HOME DEPOT, INC., 104 F.3d 1299, 1302-03 (Fed. Cir. 1997) (holding
that the district court erred in interpreting the phrase "conductive liquid-like
medium" as being limited to liquids having a conductivity similar to the
examples listed in the specification). The fact that the written description
focuses on characteristics and functions of the disclosed
-11-
<PAGE>
embodiments does not prevent the patentee from claiming an invention broader
than the disclosed embodiments. See ELECTRO MED. SYS., S.A. V. COOPER LIFE
SCIENCES, INC., 34 F.3d 1048, 1054 (Fed. Cir. 1994) ("claims are not to be
interpreted by adding limitations appearing only in the specification"); SRI
INT'L V. MATSUSHITA ELEC. CORP. OF AM., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (EN
BANC) ("If everything in the specification were required to be read into the
claims, or if structural claims were to be limited to devices operated precisely
as a specification-described embodiment is operated, there would be no need for
claims.").
In this case, the difference between the broad term "heart" and more
specific references to only the atria or to only the ventricles is clear to
anyone skilled in the art. The deliberate use of the broader terms "heart" and
"cardioverting device" in the claims, when contrasted with the narrower language
in the specification, indicates an intentional choice by the patentee to reach
beyond the embodiments discussed in the specification. In this respect, the
language of Claim 1 itself is broad, but it is not ambiguous. Cf. SEDIMA,
S.P.R.L. V. IMREX CO., 473 U.S. 479, 499 (1985) (rejecting attempt to narrow
deliberately broad language in civil RICO statute: "[T]he fact that RICO has
been applied in situations not expressly anticipated by Congress does not
demonstrate ambiguity. It demonstrates breadth."), quoting HAROCO, INC. V.
AMERICAN NATIONAL BANK & TRUST CO., 747 F.2d 384, 398 (7th Cir. 1984), AFF'D,
473 U.S. 606 (1985). Construing the term "cardioverting device" to reach both
atrial and ventricular devices is consistent with the rest of the language in
Claim 1 of the '472 patent. As explained by CPI: "The invention of [Claim 1 of]
the '472 patent is the ability to externally program the amount of energy to be
delivered by a cardioverting device. Whether the device treats the atrium or the
ventricle has no bearing on the external programmability of energy levels that
the inventors had invented." Pl. Reply Br. at 29.
-12-
<PAGE>
The prosecution history of the '472 patent also indicates that both the
patentee and the patent examiner were fully aware of the differences between
atrial and ventricular devices and that the claim language was intentionally
drafted to reach beyond atrial cardioverting devices. First, the claims of the
'750 patent, a related "parent" application cited in the '472 patent,
distinguished between atrial cardioverters (claims 1-25, 29) and cardioverting
devices generally (claim 26). Ex. 110, '750 Patent, col. 8, L. 58 to col. 14, L.
22. The claims of the '472 patent contain no similar limit. Second, during the
prosecution of the claims in the '472 patent application, the examiner applied
ventricular prior art. Ex. 14, '472 Pros. Hist., at CPI 005590-92. These
examples from the prosecution history show that the drafters were fully aware of
the differences between atrial cardioverters, ventricular cardioverters, and
cardioverters generally, and that the examiner did not consider ventricular
devices irrelevant to the '472 claims.
CPI contends that the court should also consider as relevant intrinsic
evidence (1) an amendment that was made to the '472 patent title during claims
prosecution which eliminated the word "atrial," and (2) the granting of a term
extension for the '472 patent based on a ventricular device in 1992. During
prosecution of the '472 patent, the drafters changed the patent title from
"Command Atrial Cardioverter" to "Cardioverting Device with Stored Energy
Selecting Means and Discharge Initiating Means, and Related Method." Pl. Br. at
31-32. This change was made after the patent examiner raised an objection that
the original title and statements of invention were "not commensurate with the
claimed subject matter." Ex. 14, '472 Pros. Hist., at CPI 005590.
-13-
<PAGE>
The court is reluctant to give much weight to the title change because
the Federal Circuit has noted the "near irrelevancy of the patent title to claim
construction" and has stated that "an amendment of the patent title during
prosecution should not be regarded as having the same or similar effect as an
amendment of the claims themselves by the applicant." PITNEY BOWES, INC. V.
HEWLETT-PACKARD CO., 182 F.3d at 1312 (concluding that the district court
attached too much weight in its claim construction to the patent title and to
the amendment of that title). In any event, the title change certainly does not
support defendants' effort to construe the claim language narrowly to exclude
devices that treat ventricular conditions.
The application for an extension of the '472 patent term explicitly
stated that the approved product treated ventricular tachycardia and ventricular
fibrillation and that Claim 1 covered the product. Plaintiffs contend that the
extension could not have been granted unless the Patent Office agreed that the
'472 patent claims could reach ventricular cardioverters. Pl. Reply Br. at 36;
Ex. 14, '472 Pros. Hist., Request for Extension of Patent Term. However, it is
not clear where an application for a patent term extension fits in the
interpretive hierarchy. Certainly the device descriptions in a patent extension
application cannot be read to amend the claims or specification of the original
patent document. The patent term extension is consistent with the clear language
of Claim 1, but the claim language itself is by far the most important evidence
that supports plaintiffs' interpretation of "cardioverting device."(5)
-----------------------
(5)CPI also contends the court should consider evidence of licenses and
royalty payments among manufacturers of cardioverting devices. CPI believes this
evidence will show that defendants have construed the claims of CPI's patents as
covering the defendants' devices. CPI has not offered any specific case support
for using such evidence in construing ambiguous claim language, and the court
has not considered such evidence for two principal reasons. First, under
Markman, it is clear that evidence relevant to claim construction should be
publicly available evidence. See 52 F.3d at
-14-
<PAGE>
Defendants have cited several statements made by the inventors and
patentees during the prosecution of a parent application to the continuation
application that actually resulted in the '472 patent. Defendants argue that
these statements, like the language of the '472 specification, limit the scope
of the '472 patent claims to atrial cardioverting devices. Def. Br. at 23-24.
The cited statements include the following:
The broad invention disclosed in the parent and
instant applications relates to an implanted electronic
device which is manually operable from external to the skin
of the wearer, for accomplishing ATRIAL cardioversion. Never
before has such a device been conceived, and it is therefore
the firm belief and opinion of the applicants that their
broad invention is patentable over the prior art.
--------------------------------------------------------------------------------
978-79, 987 (discussing the importance of the public record). Other inventors
are entitled to know the scope of the claims and may try to design around those
claims. See VITRONICS, 90 F.3d at 1583. If evidence of licensing agreements and
royalty payments (which are often confidential) were deemed relevant to claim
construction, the scope of claims could not be known without access to private,
often highly confidential information from multiple sources in an industry.
Second, as the evidence in this case suggests, an industry may operate on the
basis of a complex web of cross-licensing agreements negotiated on the basis of
a complicated matrix of business considerations and legal risks. The fact that
licenses have been negotiated and royalties paid offers little or nothing of
probative value as to how claim language should be construed when a court is
finally called upon to provide a definitive construction.
-15-
<PAGE>
Ex. 118 at 8 (remarks supporting an amendment to the claims and description in
patent application Serial No. 641,381, dated December 17, 1975) (emphasis
added).(6) Similarly:
Because these two types of fibrillation are so
different, ventricular defibrillation and atrial
defibrillation are not suited for indiscriminate comparison.
It is on this basis that the application of the Schuder et al
article is deemed improper.
In the February 23, 1977 Action, it is alleged that
an obvious step would be to combine the teachings of a
Schuder et al article, admittedly directed to ventricular
defibrillation, with a Charms patent, which suggested atrial
defibrillation. This combination is untenable for two basic
reasons. First, even if the references were to be combined,
the man having ordinary skill in the art would have evolved a
FULLY AUTOMATIC implantable atrial defibrillator; based upon
his awareness of ventricular defibrillation technology, he
would not have considered a non-automatic approach.
Ex. 119 at 2 (response to patent examiner, dated June 22, 1977) (emphasis in
original).
The above-identified application relates to a non-automatic
atrial defibrillator. This device is in every way practical
and realistic. The wearer is able to recognize when he is
experiencing atrial fibrillation; and he, himself, can
initiate a defibrillating procedure. Or, if he chooses, the
individual can consult with his physician, discuss his
suspected arrhythmia, and decide either to, or not to,
initiate a defibrillating procedure. While ventricular
defibrillation is a necessity to save a life, and while a
reaction to ventricular fibrillation must be immediate,
atrial defibrillation is an elective procedure.
Accordingly, the invention described in the
above-identified application involves far more than merely
borrowing from the art of ventricular defibrillation. The
concept of a fully-implantable non-automatic atrial
defibrillator can be thought of as an accommodation to a
heart patient; with such a device, defibrillation can be
accomplished at home, without the inconvenience of repeated
visits to a physician.
Ex. 111,P. 11 (Declaration of Mieczyslaw Mirowski, dated June 8, 1977).
-----------------------
(6)The continuation application that resulted in the '472 patent was
filed on August 9, 1979.
-16-
<PAGE>
For the reasons set forth in my October 28, 1976
Declaration and those set forth in the foregoing paragraphs,
I am of the firm belief that an implantable non-automatic
ventricular defibrillator is unrealistic and totally
impractical, because not useful by the suffering individual
himself, and because the suffering individual is not likely
to experience ventricular fibrillation in the presence of one
skilled in medicine and aware that the individual wears an
implanted defibrillator.
Ex. 112,P. 5 (Declaration of Morton M. Mower, dated June 8, 1977).
While statements made during the prosecution of a parent application
are part of the prosecution history and relevant to interpreting claims in a
subsequent daughter application, see WANG LABORATORIES, INC. V. AMERICA ONLINE,
INC., 197 F.3d 1377, 1383-84 (Fed. Cir. 1999), they form only part of the
interpretive backdrop. In this case, the parent application, Serial No. 641,381,
was abandoned. Significantly, at least some of the claims in the abandoned
parent application referred explicitly to the "atrium" and to devices for
converting "supra-ventricular" cardiac arrhythmias. Ex. 118 at 3-7.
Defendants are correct to point out through the inventors' statements
that the devices disclosed in the abandoned parent application (as well as the
devices in Figure 1 and Figure 3 of the '472 patent) are not suited for
ventricular defibrillation. However, the removal of all references to the words
"atrium," "atrial," and "supra-ventricular" in the claims of the '472 patent
indicates a deliberate intent to broaden the claims over those in the abandoned
parent application. The statements made in support of the abandoned parent
application do not limit the unambiguous language in the claims of the '472
patent.(7)
-----------------------
(7)In contrast to the claims in the abandoned parent application, the
claims in the '472 patent also make no explicit reference to a "non-automatic"
or "manually operated" device. In fact, the claims of the '472 patent were
specifically amended during prosecution to replace the phrase
-17-
<PAGE>
Nevertheless, defendants have cited Federal Circuit decisions that are
difficult to reconcile with the cases suggesting that a claim may be broader
than the specific embodiment disclosed in a specification. For example, in
GENTRY GALLERY, INC. V. BERKLINE CORP., 134 F.3d 1473, 1480 (Fed. Cir. 1998),
the court wrote that "claims may be no broader than the supporting disclosure,
and therefore . . . a narrow disclosure will limit claim breadth." In GENTRY
GALLERY, however, the court was deciding an issue of validity and held invalid
broad claims that reached beyond the disclosure. In LAITRUM CORP. V. MOREHOUSE
INDUSTRIES, INC., 143 F.3d 1456, 1462-63 (Fed. Cir. 1998), the court rejected a
number of arguments by a patentee who sought a broad claim interpretation: "It
is entirely proper to 'use the specification in order to determine what the
inventor meant by terms and phrases in the claims.' * * * While claims are not
necessarily limited by the written description, it is relevant that nothing in
the written description suggests that the driving surfaces can be anything but
flat." In NORTH AMERICAN VACCINE, INC. V. AMERICAN CYANAMID CO., 7 F.3d 1571,
1576-77 (Fed. Cir. 1993), the court noted that the written description
requirement of 35 U.S.C. ss. 112, P. 1 warranted a claim construction limited to
the disclosures in the specification. See also MODINE MANUFACTURING CO. V.
UNITED STATES INT'L TRADE COMM'N, 75 F.3d 1545, 1551 (Fed. Cir. 1996) ("when the
preferred embodiment is described in the specification as the invention itself,
the claims are not necessarily entitled to a scope broader than that
embodiment").
--------------------------------------------------------------------------------
"implantable non-automatic converting device" with the more general term
"cardioverting device." Ex. 14, '472 Pros. Hist., at CPI 005600-07.
-18-
<PAGE>
In the present case, however, both the deliberate use of broad language
in the claims and the prosecution history show a clear choice to write claims
that would apply to the entire heart, including the ventricles. To the extent
that the broad claim language raises issues of validity, those issues may be
addressed later in the case. They would not support an artificially narrowed
reading of the deliberately broad claim language applying to the entire heart.
The court therefore intends to define "cardioverting device" for the jury as "a
device capable of correcting high-rate arrhythmic heart conditions by applying
non-pacing electrical shocks to the heart. Such heart conditions include atrial
arrhythmias and/or ventricular arrhythmias." For essentially the same reasons,
the terms (1) "cardioverting a heart" and "cardioverting the heart" in Claim 18
of the '472 patent, and (2) "cardioverting device" in Claim 1 of the '191 patent
will be defined to include both atrial and ventricular cardioversion. See '472
Patent, col. 10, ll. 62-63; col. 12, LL. 6-8; '191 Patent, col. 8, L. 56.
B. '472 CLAIM 1: "STORAGE MEANS FOR STORING"
The second disputed phrase in Claim 1 of the '472 patent is "storage
means for storing." In addition to the standard hierarchy of intrinsic and
extrinsic interpretive resources, this phrase is the first of several elements
in the '472 patent that potentially brings into play a special subset of
interpretive rules under paragraph 6 of 35 U.S.C. ss. 112 ("ss. 112 P. 6").
Section 112 P. 6 provides:
An element in a claim for a combination may be expressed as a
means or step for performing a specified function without the
recital of structure, material, or acts in support thereof,
and such claim shall be construed to cover the corresponding
structure, material, or acts described in the specification
and equivalents thereof.
-19-
<PAGE>
Claims phrased under ss. 112 P. 6 are often called
"means-plus-function" or "step-plus-function" claims. In operation, ss. 112 P. 6
allows a patentee to state claims in broad, general language by stating the
"functions" of the invention, rather than by repeating the detailed structures
or materials (in apparatus claims) or detailed acts (in method claims) that
perform the claimed functions. A "means-plus-function" or "step-plus-function"
statement in a claim may be an economical way of expressing the more complex
structure or acts covered by the claim. The patentee may use ss. 112 P. 6
function statements so long as the "missing" detail appears in the
specification. See KEMCO SALES, INC. V. CONTROL PAPERS CO., 208 F.3d 1352, 1360
(Fed. Cir. 2000) (the duty to link structure to function is the "statutory quid
pro quo" for the convenience of employing ss. 112 P. 6). The relevant structural
details or relevant acts from the specification are then essentially
incorporated into the function claims. See MULTIFORM DESICCANTS, 133 F.3d at
1479 (discussing the form and purpose of claims containing functional
limitations written in the ss. 112 P. 6 "means-for" form).
The "cost" of using a ss. 112 P. 6 function statement, especially if
done unintentionally, is that the scope of the claim is restricted to the
particular structures or acts disclosed in the specification, as well as their
equivalents. See PERSONALIZED MEDIA COMMUNICATIONS, LLC V. INTERNATIONAL TRADE
COMM'N, 161 F.3d 696, 703 (Fed. Cir. 1998) ("ss. 112, P. 6 operates to restrict
claim limitations drafted in such functional language to those structures,
materials, or acts disclosed in the specification (and their equivalents) that
perform the claimed function.").(8)
-----------------------
(8)Structure in an accused device will be a ss. 112 P. 6 "equivalent"
if (1) it performs the identical function as the function stated in the claim,
and (2) it is otherwise insubstantially different with respect to structure as
the disclosed structure. See KEMCO SALES, 208 F.3d at 1364, citing ODETICS, INC.
V. STORAGE TECH. CORP., 185 F.3d 1259, 1267 (Fed. Cir. 1999); PENNWALT CORP. V.
-20-
<PAGE>
The word "means" is a generic description of an apparatus element, and
the implementation of such a concept is by structure or material. See O.I. CORP.
V. TEKMAR CO., 115 F.3d 1576, 1582-83 (Fed. Cir. 1997). The term "steps" refers
to the generic description of elements of a process, and the term "acts" refers
to the implementation of such steps. Thus, for apparatus claims,
means-plus-function interpretation rules apply if the claim is expressed as a
means for performing a specified function without also identifying in the claim
itself the specific material or structure that accomplishes that function. For
method claims, step-plus-function rules apply if the claim element is expressed
as a step for performing a specified function without stating in the claim
itself the more specific acts that explain how to accomplish the function. See
ID.
If ss. 112 P. 6 applies to a claim, a court construing the claim must
then (1) "construe the function recited in that claim," and (2) "determine what
structures [or acts] have been disclosed in the specification that correspond to
the means [or steps] for performing that function." KEMCO SALES, 208 F.3d at
1361. Sometimes, however, the threshold issue is whether ss. 112 P. 6 applies at
all. The Federal Circuit has established some general rules of thumb.
First, the specific language of the claim can create a presumption that
ss. 112 P. 6 either does or does not apply:
--------------------------------------------------------------------------------
DURAND-WAYLAND, INC., 833 F.2d 931, 934 (Fed. Cir. 1987) (EN BANC).
Significantly, the test developed for the doctrine of equivalents is not wholly
transferable to the ss. 112 P. 6 statutory equivalence context due to the
functional identity requirement. See ODETICS, 185 F.3d at 1267.
-21-
<PAGE>
[U]se of the word "means" creates a presumption that ss.112,
P. 6 applies, SEE YORK PRODS., INC. V. CENTRAL TRACTOR, 99 F.3d
1568, 1574 (Fed. Cir. 1996) ("In determining whether to apply
the statutory procedures of [ss. 112, P. 6], the use of the
word 'means' triggers a presumption that the inventor used
this term advisedly to invoke the statutory mandates for
means-plus-function clauses."), and . . . the failure to use
the word "means" creates a presumption that ss.112, P. 6 does
not apply, SEE [MAS-HAMILTON GROUP V. LAGARD, INC., 156 F.3d
1206, 1213 (Fed. Cir. 1998)]. These presumptions can be
rebutted if the evidence intrinsic to the patent and any
relevant extrinsic evidence so warrant.
PERSONALIZED MEDIA, 161 F.3d at 703-04 (footnotes omitted); see also KEMCO
SALES, 208 F.3d at 1361 (discussing the quoted language from PERSONALIZED MEDIA
with approval; "plastic envelop closing means" limitation invokes the
presumption and is in means-plus-function format). Similarly, if a claim drafter
uses "steps for" to express a method claim element, it is a signal that the
drafter intended to invoke ss.112 P. 6. See GREENBERG V. ETHICON ENDO-SURGERY,
INC., 91 F.3d 1580, 1583 (Fed. Cir. 1996).
Second, if an apparatus claim element itself arguably identifies some
structure, the test is whether one of skill in the art would understand the term
at issue to connote sufficiently definite structure. See PERSONALIZED MEDIA, 161
F.3d at 703-05 (finding that the term "digital detector" recited sufficient
structure to avoid ss. 112 P. 6; "Even though the term 'detector' does not
specifically evoke a particular structure, it does convey to one knowledgeable
in the art a variety of structures known as 'detectors.'"); GREENBERG V. ETHICON
ENDO-SURGERY, INC., 91 F.3d at 1583 (stating that the inquiry is whether the
term used as the name for structure "has a reasonably well understood meaning in
the art"). Where a claim recites a function but the claim itself also sets forth
sufficient structure or material to perform entirely the recited function, the
claim is not a means-plus-function
-22-
<PAGE>
claim even if it uses the term "means." See PERSONALIZED MEDIA, 161 F.3d at 704,
citing SAGE PRODUCTS, INC. V. DEVON INDUSTRIES, INC., 126 F.3d 1420, 1427-28
(Fed. Cir. 1997).
Third, in method claims, merely claiming a step without recital of a
function is not analogous to a means plus a function. See O.I. CORP. V. TEKMAR
CO., 115 F.3d at 1583 (holding that the step of "passing the analyte slug
through a passage . . ." was not subject to ss. 112 P. 6). Thus, claiming a
"step" by itself, or even a series of steps, does not invoke ss. 112 P. 6. See
ID. Under this rule, a patentee can define a method or process claim containing
steps that begin with a gerund such as passing, heating, reacting, transferring,
etc. without necessarily subjecting the claim to ss. 112 P. 6 limitations. See
ID.
Applying these rules to Claim 1 of the '472 patent, the parties
disagree as to whether ss. 112 P. 6 controls the element "storage means for
storing." St. Jude contends that "storage means for storing" is a
means-plus-function recital and that "storage means" therefore should be limited
to "a capacitor" - the structure disclosed in the specification that performs
the stated function. CPI initially asserts that ss. 112 P. 6 does not apply and
that there is no need for further interpretation of the phrase. Pl. Reply Br. at
37. Arguing in the alternative, and assuming that ss. 112 P. 6 does apply, CPI
offers the following construction: "The corresponding structure is a capacitor
and equivalents thereof. A combination of capacitors is the equivalent of a
single capacitor." Pl. Amd. Prop. Conc. of Law at 5.
The phrase "storage means for storing" is subject to ss. 112 P. 6. As
written in the claim, some unidentified "storage means" performs the function of
"storing energy to convert an abnormal
-23-
<PAGE>
cardiac rhythm to normal sinus rhythm." '472 Patent, col. 8, LL. 65-66. The
claim is stated in means-plus-function form. Because the claim uses the key
phrase "means for," it is presumed that the claim falls under ss. 112 P. 6. CPI
has not shown any basis for departing from the presumption in this instance. One
skilled in the art would not understand the broad term "storage means" to
connote sufficiently definite structure.
Because ss. 112 P. 6 applies, the court must identify the structure
disclosed in the specification that performs the function of "storing energy to
convert an abnormal cardiac rhythm to normal sinus rhythm." See KEMCO SALES, 208
F.3d at 1361. The court agrees with St. Jude that the capacitors disclosed in
the two embodiments of the device are the only structures that perform the
function at issue. See '472 Patent, Figs. 1 & 3; col. 7, ll. 44-64.
CPI has asked the court to include in the claim construction the
statement that a combination of capacitors is the equivalent of a single
capacitor. It is not appropriate to define as a matter of law at the stage of
claim construction the structures that may be "equivalents" of the disclosed
means. "Whether an accused device or method infringes a claim either literally
or under the doctrine of equivalents is a question of fact. Literal infringement
of a ss. 112, P. 6 limitation requires that the relevant structure in the
accused device perform the identical function recited in the claim and be
identical or equivalent to the corresponding structure in the specification."
CATERPILLAR INC. V. DEERE & CO., 224 F.3d 1374, 1379 (Fed. Cir. 2000) (internal
quotation and citation omitted); accord, IMS TECHNOLOGY, INC. V. HAAS
AUTOMATION, INC., 206 F.3d 1422, 1430 (Fed. Cir. 2000) ("Whether an accused
device or method infringes a claim with a ss. 112, P. 6 limitation, i.e.,
whether it performs the identical function with the same structure, materials,
or acts described in the specification or an
-24-
<PAGE>
equivalent thereof, is a question of fact."). The court therefore will not adopt
the portion of CPI's proposed construction stating that a "combination of
capacitors is the equivalent of a single capacitor." It is not possible to say
at this point that a reasonable jury would be required to conclude that multiple
capacitors are the equivalent of a single capacitor. The term "storage means" in
Claim 1 of the '472 patent will be defined as "a capacitor and equivalents
thereof."
C. '472 CLAIM 1: "DELIVERY ELECTRODE MEANS FOR DISCHARGING"
The third disputed phrase in Claim 1 identifies "delivery electrode
means for discharging the stored energy into the heart of a wearer of the
device." '472 Patent, col. 8, LL. 67-68. CPI asserts that ss. 112 P. 6 does not
apply to "delivery electrode means for discharging," while St. Jude contends
that the phrase is a means-plus-function statement and that the disclosed
structure is "an electrode that is implanted in the atrium of the patient's
heart." Def. Prop. Conc. of Law at 2.
The claim element is stated in means-plus-function form with "means
for" language, so the presumption is that ss. 112 P. 6 applies. CPI argues that
there is a basis for departing from the presumption in this instance because one
skilled in the art would understand the term "delivery electrode" to connote
sufficiently definite structure (i.e., an electrode) to perform the stated
function. See, e.g., PERSONALIZED MEDIA, 161 F.3d at 703-05 (holding that the
term "digital detector" recited sufficient structure to avoid ss. 112 P. 6;
claim did not use word "means"); MEDIACOM CORP. V. RATES TECHNOLOGY, INC., 2 F.
Supp.2d 17, 27 (D. Ma ss. 1998) (holding that "switch means operatively
connected to said first jack means for disconnecting said first telephone from
said network" was not
-25-
<PAGE>
a ss. 112 P. 6 means-plus-functION statement "because it describes the structure
that supports the disconnecting function (i.e. a switch or switches).").
The court disagrees that the "delivery electrode means" element recites
sufficient structural detail to overcome the presumption that ss. 112 P. 6
controls. In cases where the Federal Circuit has departed from the presumption
established by the use of "means for," the court has emphasized that the claim
language provided detail beyond some minimal statement of structure. See, e.g.,
ENVIRCO CORP. V. CLESTRA CLEANROOM, INC., 209 F.3d 1360, 1365 (Fed. Cir. 2000)
(finding that "second baffle means" rebuts the presumption that ss. 112 P. 6
applies because the term "baffle" itself imparted structure and because the
claim gave further location and formational details); RODIME PLC V. SEAGATE
TECHNOLOGY, INC., 174 F.3d 1294, 1303-04 (Fed. Cir. 1999) ("The claim also
recites the specific location and interconnection of each of these structural
sub-elements. . . . This detailed recitation of structure for performing the
moving function takes this claim element out of the scope of ss. 112, P. 6.");
COLE V. KIMBERLY-CLARK CORP., 102 F.3d 524, 531 (Fed. Cir. 1996) (finding that
the claim language described definite structure as well as the location and
extent of the structure). Further, in UNIDYNAMICS CORP. V. AUTOMATIC PRODUCTS
INT'L, LTD., the Federal Circuit adhered to the presumption established by use
of the term "means" and found that the claim element "spring means tending to
keep the door closed" invoked ss. 112 P. 6. 157 F.3d 1311, 1319 (Fed. Cir.
1998). The court distinguished COLE V. KIMBERLY-CLARK on the basis that the
claim in COLE had not only described definite structure but also described the
location and extent of the structure. See ID.
St. Jude's proposed construction, which requires the electrode to be
implanted in the atrium of the patient's heart, is also faulty. The function to
be performed - "discharging the stored energy
-26-
<PAGE>
into the heart of a wearer of the device" - is stated in terms broad enough to
include both atrial and ventricular therapies. A limitation requiring the
discharging end of the electrode to be implanted in the atrium would import
structural detail of the disclosed devices beyond what is required to perform
the recited function. See CHIUMINATTA CONCRETE CONCEPTS, INC. V. CARDINAL
INDUSTRIES, INC., 145 F.3d 1303, 1308 (Fed. Cir. 1998) (claim construction
properly omitted details of the embodiment that defined structure unrelated to
the recited function).
The use of an atrial catheter electrode is necessary to the disclosed
embodiments, but not necessary to the function recited in the claim. The claim
element is concerned more broadly with a means by which to transfer energy from
the device to any point in the heart where the electrical therapy is to be
delivered. See '472 Patent, col. 7, LL. 39-43 ("AND gate 82 switches the
discharge switch 84 to its conductive state, thereby discharging the storage and
discharge capacitor 78 through the heart 76 by way of a catheter 72 implanted in
or about the heart, as in the right atrium 74.").
The court intends to define "delivery electrode means" as "structure
identical or equivalent to a catheter-type electrode extending from the
implanted device to the heart, such that the point of discharge is located at
the point where the electrical therapy is to be delivered."
D. '472 CLAIM 1: "CHARGING MEANS FOR DELIVERING"
The fourth disputed phrase in Claim 1 indicates that a "charging means"
performs the function of "delivering to said storage means said energy to
convert said abnormal cardiac rhythm." '472 Patent, col. 9, LL. 4-6. St. Jude
contends that this element is controlled by ss. 112 P. 6 and
-27-
<PAGE>
proposes the following construction: "The 'charging means'. . . requires energy
to be transmitted from the physician's external console through the skin of the
patient to the implanted device." CPI responds that the word "charging" in the
claim language adds the structural limitation of a "charging circuit" and
that ss. 112 P. 6 therefore does not apply. In the alternative, CPI argues that,
even if ss. 112 P. 6 does apply, power inverter 52 in Figures 1 and 3 is the
structure that performs the stated function, or that, at the very least, the
court should adopt a claim construction that "identifies an external source and
an implanted battery as interchangeable energy sources for the
physician-operated embodiment specifically disclosed in the '472 patent." Pl.
Reply Br. at 41.
The ss. 112 P. 6 interpretive rules apply to the element "charging
means for delivering." The adjective "chargiNG" does not identify sufficient
structure to defeat the presumption raised by the use of the "means for"
language. The next step is to identify the disclosed structure that performs the
function of delivering energy to the storage means.
Both parties seem to agree that the "charging means" generally is
responsible for transferring energy from one location (an energy source) to the
storage means (i.e., the capacitor). The patent specification supports this
general construction. In the physician-operated embodiment shown in Figure 1,
energy is transferred from an energy source that is external to the skin to the
capacitor via a series of steps. The patent specification, discussing Figure 1,
states that "power inverter 52 and the associated circuitry . . . serves the
purpose of charging the storage capacitor at a predetermined energy level." '472
Patent, col. 5, LL. 56-60. In the patient-operated embodiment in Figure 3,
however, energy is transferred from an internal battery to the capacitor via
switch 118 and power inverter 52.
-28-
<PAGE>
The real dispute over the "charging means" language centers on whether
the language of Claim 1, viewed in its entirety, limits the supporting structure
for the "charging means" solely to the charging structure identified in the
physician-operated embodiment. St. Jude contends that the claim language applies
only to the "charging means" used in the physician-operated embodiment because
(1) the claim later states that PROGRAMMING COMMANDS designate the energy
magnitude that is to be used to treat the arrhythmia, and (2) only the
physician-operated embodiment uses external PROGRAMMING COMMANDS to designate
the energy level. The specification does not state that an internal battery is
interchangeable with the disclosed external energy source in Figure 1, so St.
Jude asserts that "the patent teaches that the type of energy source is not
optional." Def. Br. at 34 n.17.(9)
CPI's response is that one of ordinary skill in the field of implanted
cardioverters "would recognize that the implanted battery is interchangeable
with the external console as sources of energy for the physician-operated
embodiment covered by claim 1." Pl. Reply Br. at 41. Thus, according
-----------------------
(9)St. Jude's argument supposes that the patient-operated embodiment
(Fig. 3) has no direct application to Claim 1 because the cardioverting device
described in the claim is expressly stated to be an "an implantable externally
programmable cardioverting device." St. Jude is correct that Figure 3 does not
disclose an "externally PROGRAMMABLE" device and that, therefore, Figure 3 does
not disclose a device as described in Claim 1. The energy levels for
cardioversion in the patient-operated embodiment cannot be changed once the
device is implanted. The same is true for Claim 18, which indicates that "a
receiver for receiving CONTROL INFORMATION" is an essential component of the
implanted "package." The patient-operated embodiment has no such receiver.
-29-
<PAGE>
to CPI, the charging circuit in Figure 1 and the charging circuit in Figure 3
are interchangeable, disclosed structures which correspond to the "charging
means" recited in Claim 1.
CPI's argument about the "charging means" is more persuasive. Nothing
in the specification indicates that the PARTICULAR source of energy used to
cardiovert the heart is essential to the operation of an externally programmable
cardioverting device. In addition, the principle of claim differentiation
supports this view. Under the doctrine of claim differentiation, the general
rule is that "limitations stated in dependent claims are not to be read into the
independent claim from which they depend." KARLIN TECHNOLOGY, INC. V. SURGICAL
DYNAMICS, INC., 177 F.3d 968, 972 (Fed. Cir. 1999); see also TANDON CORP. V.
UNITED STATES INT'L TRADE COMM'N, 831 F.2d 1017, 1023 (Fed. Cir. 1987) ("To the
extent that the absence of such difference in meaning and scope would make a
claim superfluous, the doctrine of claim differentiation states the presumption
that the difference between claims is significant."). Dependent Claim 6 of the
'472 patent reads: "In the device of claim 1, wherein said receiver means
receives power signals generated from external to the skin of the wearer; said
device including utilizing means for utilizing said power signals as electrical
power necessary for the operation of the device." '472 Patent, col. 9, LL.
44-48. The added limit in Claim 6 of using power from outside the patient's skin
further indicates that Claim 1 should be construed more broadly to include
devices that do NOT have "means for utilizing said power signals as electrical
power necessary for the operation of the device."
The court intends to construe "charging means" as follows: "a power
inverter and the associated charging circuitry necessary to perform the function
of transferring energy from a power source to the storage means. The charging
means must be identical or equivalent to the power
-30-
<PAGE>
inverter and associated circuitry disclosed and described in either (a) the
physician-operated embodiment described in the '472 patent (Figure 1), or (b)
the patient-operated embodiment described in the '472 patent (Figure 3)."
-31-
<PAGE>
E. '472 CLAIM 1: "INITIATING MEANS FOR INITIATING THE DISCHARGE
OF CONVERTING ENERGY"
Claim 1 of the '472 patent states that the cardioverting device must
include "initiating means for initiating the discharge of converting energy into
the heart of the wearer after the stored energy has reached said predetermined
magnitude." '472 Patent, col. 9, LL. 10-13. The parties agree that the
"initiating means" claim element is subject to ss. 112 P. 6, but they disagree
on the structure to be associated with the stated function.
CPI contends that the specification teaches two different methods for
initiating the discharge of energy into the heart. First, the physician-operated
embodiment discloses a button located on the physician-controlled console. '472
Patent, Fig. 2, element 40. The physician presses the button to initiate the
discharge of the capacitor once the capacitor has been charged to the desired
level. '472 Patent, col. 4, LL. 43-45; col. 5, LL. 1-4. Second, the
patient-operated embodiment discloses a mechanism by which the implanted device
itself initiates the discharge of the stored energy when the capacitor is fully
charged and the heart is in the proper stage of the ventricular cycle. '472
Patent, Fig. 3, element 82. CPI claims that the initiating means in the
physician-operated device involves a manual procedure, while the initiating
means in the patient-operated device is structure that performs the function
automatically.
St. Jude's proposed construction of "initiating means" limits the
associated structure to a "manually operated triggering device, such as a
button." According to St. Jude, the specification clearly ties the push button
in Figure 2 to the stated function of initiating the discharge of energy. See
'472 Patent, col. 4, LL. 43-45. As far as the patient-operated embodiment, St.
Jude contends:
-32-
<PAGE>
"At most, the patient-initiated embodiment disclosed in the patent teaches a
system for continued operation with limited patient participation after an
initial trigger." Def. Surreply Br. at 12. Thus, according to St. Jude, nowhere
does the '472 patent teach "automatic" initiation.
The language of the recited function is the key to the construction of
this element. The initiating structure must initiate "the discharge of
converting energy into the heart of the wearer AFTER THE STORED ENERGY HAS
REACHED SAID PREDETERMINED MAGNITUDE." '472 Patent, col. 9, LL. 10-13 (emphasis
added). Thus, the focus is on what happens AFTER the capacitor has been charged
to a predetermined level. In the patient-operated device, the patient's magnet
is already in place at the point the capacitor reaches its full charge. In fact,
the magnet initiates the charging process. The structure that later initiates
the discharge, however, is not the magnet. The specification explains the
structure involved in the initiating process as follows:
[W]hen discharge capacitor 78 reaches the proper level of
charging, a "ready" signal is issued and is passed to AND
gate 82 via line 80. At the same time, the ventricular
catheter 126 or another appropriate sensing lead senses the
heart function, and a set of QRS synchronization pulses is
produced by circuit 132 and fed to AND gate 82 via line 56.
Upon the simultaneous occurrence of a "ready" signal
and a QRS pulse, AND gate 82 switches discharge switch 84 to
its conductive state and the discharge capacitor 78
discharges through the heart 76 of the patient via atrial
catheter 72.
'472 Patent, col. 7, L. 61 to col. 8, L. 5. This description indicates that "AND
gate 82" performs the function of initiating the discharge process upon
receiving signals from discharge capacitor 78 and the QRS circuit. The presence
of the magnet over the device is a necessary condition that must be fulfilled
before the "initiating" function is performed in the patient-operated
embodiment, but the magnet is not structure that accomplishes the stated
function. Therefore, the court rejects St. Jude's
-33-
<PAGE>
proposed construction, which would limit the definition of "initiating means" to
manually-operated triggering devices.
The court intends to define "initiating means" as follows: The accused
device contains "initiating means" as stated in Claim 1 of the '472 patent if it
contains structures identical or equivalent to (1) AND gate 82 as shown in
Figure 3 and described in the specification, or (2) the manually operated
discharge button 40 as shown in Figure 2 and described in the specification.(10)
F. '472 CLAIM 1: "STORED ENERGY FOR CONVERTING SAID ABNORMAL
CARDIAC RHYTHM"
The final paragraph of Claim 1 of the '472 patent states that the
cardioverting device must be capable of receiving programming commands from
external to the skin of the wearer. The programming commands received by the
device designate "a predetermined magnitude of stored energy for converting said
abnormal cardiac rhythm . . . ." '472 Patent, col. 9, LL. 16-20. St. Jude
contends that the source for the "stored energy" mentioned in the claim must be
external to the patient because only the physician-operated embodiment allows
programming of the amplitude of the shock.
-----------------------
(10)By adopting a construction of the term "initiating means" that does
not include a limitation to manually-operated devices, the court does not intend
to suggest that Claim 1 necessarily reaches a completely automatic device in the
sense that the device automatically DETECTS AND TREATS an arrhythmia without,
for example, a patient placing a magnet near the device or a physician using an
external console to control the delivery of shocks to the heart.
-34-
<PAGE>
As stated above in interpreting the term "charging means," the court
agrees with CPI that the '472 patent discloses that an external power source and
an internal battery are interchangeable sources of power for cardioversion. The
court does not anticipate defining "stored energy" or "programming commands" for
the jury beyond what is already stated in the claim.
G. '472 CLAIM 18: DISPUTED TERMS SIMILAR TO TERMS IN CLAIM 1
Claim 18 defines a method for electrically cardioverting a patient's
heart, although it has apparatus elements. The claim reads:
18. A method for electrically cardioverting a heart, the
method comprising the steps of:
implanting an electronic package beneath the skin of
a wearer, said electronic package including a
storage element for storing electrical energy to
convert an abnormal cardiac rhythm to normal sinus
rhythm, delivery electrodes for discharging said
stored energy into the heart of the wearer, a
receiver for receiving control information from
external to the skin of the wearer, said control
information designating a selected magnitude of
energy to be discharged through said delivery
electrodes into the heart of the wearer, and charge
control means responsive to said control information
for storing said selected magnitude of stored energy
in said storage element;
sensing an abnormal cardiac rhythm, wherein
cardioversion is required;
delivering said control information through the skin
of the wearer to cause the storage element to store
said selected magnitude of energy; and
electrically cardioverting the heart by discharging said
selected magnitude of stored energy through said delivery
electrodes into the heart of the wearer.
'472 Patent, col. 10, L. 62 to col. 12, L. 8.
-35-
<PAGE>
Several of the disputed terms in the method claim are identical to or
very similar to the disputed terms in apparatus Claim 1. However, even where the
language used in the method and apparatus claims is identical, the method claims
must be considered independently. It is possible that the same language will
have a different meaning, especially where, as is true here, some claim elements
are subject to ss. 112 P. 6:
We understand that the steps in the method claim are
essentially in the same language as the limitations in the
apparatus claim, albeit without the "means for"
qualification. However, even if we were to hold that the word
"passage" in the apparatus claims meets the section 112, P.
6, tests, we would not agree with Tekmar that the
"parallelism" of the claims means that the method claims
should be subject to the requirements of section 112, P. 6.
Each claim must be independently reviewed in order to
determine if it is subject to the requirements of section
112, P. 6. Interpretation of claims would be confusing indeed
if claims that are not means- or step-plus-function claims
were to be interpreted as if they were, only because they use
language similar to that used in other claims that are
subject to this provision.
O.I. CORP. V. TEKMAR CO., 115 F.3d at 1583-84. The court will dispose
of Claim 18 issues by reference to the disposition of Claim 1 issues
only where it is appropriate to do so.
1. '472 CLAIM 18: "A METHOD FOR ELECTRICALLY
CARDIOVERTING A HEART"
St. Jude contends that the method for "electrically cardioverting a
heart" defined in Claim 18 is limited to atrial cardioversion. CPI proposes a
construction that would include ventricular cardioversion. The parties agree
that the issues presented in interpreting the term "cardioverting" in Claim 1
and Claim 18 are substantially identical, and they cite identical evidence in
support of their arguments.
-36-
<PAGE>
As explained above with reference to Claim 1, the language of the
claims is not ambiguous. The patentees used the word "cardioverting" to include
both atrial and ventricular devices and processes despite the fact that the two
disclosed embodiments are atrial devices. The term "electrically cardioverting a
heart" for purposes of Claim 18 of the '472 patent means "applying non-pacing
electrical shocks to the heart to correct high-rate arrhythmic heart conditions.
Such heart conditions include atrial arrhythmias and/or ventricular
arrhythmias."
2. '472 CLAIM 18: "A STORAGE ELEMENT FOR STORING
ELECTRICAL ENERGY"
The first step defined in Claim 18 of the '472 patent is the step of
"implanting an electronic package beneath the skin of a wearer." The claim then
identifies various components of the electronic package, several of which are
nearly identical to the components identified in the apparatus Claim 1 and will
be interpreted similarly.
The "implanting" step of Claim 18 states that the electronic package
must include "a storage element for storing electrical energy to convert an
abnormal cardiac rhythm to normal sinus rhythm." '472 Patent, col. 10, LL.
65-67. The significant difference between this statement and the similar
statement in Claim 1 is the substitution of the word "element" for the word
"means." Because the claim language does not use the word "means" there is no
presumption that ss. 112 P. 6 applies. However, the element is stated in purely
functional terms, so ss. 112 P. 6 still controls. See MAS-HAMILTON GROUP V.
LAGARD, INC., 156 F.3d 1206, 1213-15 (Fed. Cir. 1998) (interpreting "lever
moving element" and "movable link member" under ss. 112 P. 6); accord, AL-SITE
CORP. V. VSI INT'L, INC., 174 F.3d 1308, 1318 (Fed. Cir. 1999) ("[W]hen it is
apparent that the element invokes purely
-37-
<PAGE>
functional terms, without the additional recital of specific structure or
material for performing that function, the claim element may be a
means-plus-function element despite the lack of express means-plus-function
language.").
The proper construction of "storage element" in Claim 18 is identical
to the construction provided for "storage means" in Claim 1 above. The term
"storage element" in Claim 18 will be defined as "a capacitor and equivalents
thereof."
3. '472 CLAIM 18: "DELIVERY ELECTRODES FOR DISCHARGING
SAID STORED ENERGY INTO THE HEART OF THE WEARER"
The element "delivery electrodes for discharging said stored energy
into the heart of the wearer" in Claim 18 recites another structural element
that must be included in the implanted "electronic package." As was the case for
the term "delivery electrode means" in Claim 1, St. Jude contends that the
"delivery electrodes" element in Claim 18 is a means-plus-function element and
that the specification limits the scope of the claim to electrodes implanted in
the atrium.
Although the phrase in Claim 18 omits the word "means," the element is
otherwise not different from the "delivery electrode means" element in Claim 1.
The phrase in Claim 18 also identifies a function, and it provides no more
illumination than the parallel element of Claim 1. The court sees no valid basis
for finding that "delivery electrode means" discloses less structure than the
phrase "delivery electrodes." The court finds that the element is subject to ss.
112 P. 6 and intends to define "delivery electrodes" as "structure identical or
equivalent to a catheter-type electrode
-38-
<PAGE>
extending from the implanted device to the heart, such that the point of
discharge is located at the point where the electrical therapy is to be
delivered."
-39-
<PAGE>
H. '472 CLAIM 18: "RECEIVER FOR RECEIVING CONTROL INFORMATION
FROM EXTERNAL TO THE SKIN OF THE WEARER, SAID CONTROL
INFORMATION DESIGNATING A SELECTED MAGNITUDE OF ENERGY TO BE
DISCHARGED THROUGH SAID DELIVERY ELECTRODES INTO THE HEART OF
THE WEARER"
The parties appear to agree that ss. 112 P. 6 applies to the phrase
"receiver for receiving." The unresolved isSUE is whether, as St. Jude contends,
the energy source must be external to the skin of the patient, or whether the
energy source may also be an internal battery.
The claim language and the specification both clearly indicate that the
"CONTROL INFORMATION designating a selected magnitude of energy" comes from an
external source (e.g., the physician's console), but the ENERGY SOURCE for
cardioversion may be either external or internal. The "receiver" claim language
does not imply any limit on where the energy source must be located. As
discussed above in relation to Claim 1, the disclosed embodiments teach two
interchangeable sources for the energy that will be discharged into the
patient's heart. The physician-operated embodiment discloses an external source.
The patient-operated embodiment discloses an internal battery. One skilled in
the art would readily understand that an internal battery could be used in a
device that receives external "control information designating a selected
magnitude of energy."
The court intends to adopt CPI's proposed construction of this disputed
claim element. Therefore, "a receiver for receiving control information" is the
circuitry inside the implanted cardioverter that receives the information sent
to the device for programming the energy level.
-40-
<PAGE>
I. '472 CLAIM 18: "CHARGE CONTROL MEANS RESPONSIVE TO SAID
CONTROL INFORMATION FOR STORING SAID SELECTED MAGNITUDE OF
ENERGY IN SAID STORAGE ELEMENT."
The final disputed claim element in the "electronic package" defined in
Claim 18 identifies "charge control means responsive to said control information
for storing said selected magnitude of energy in said storage element." '472
Patent, col. 11, LL. 6-8. St. Jude contends that ss. 112 P. 6 controls, and it
proposes that: "The 'charge control means' requires energy to be transmitted
from the physician external console through the skin of the patient to the
implanted device." Def. Br. at 37. CPI contends that ss. 112 P. 6 does not apply
and that "charge control means" should be interpreted identically to "charging
means" in Claim 1 of the '472 patent.
The court finds that ss. 112 P. 6 applies to the "charge control means"
claim element. The element uses the KEY word "means," and the claim element
recites a function without identifying sufficiently definite structure for
performing that function. The stated function is to control the charging of the
storage element (i.e., the capacitor) in a manner that is responsive to the
control information. The claim earlier defines the "control information" as
information received by the device from an external source that designates a
selected magnitude of energy for cardioversion. '472 Patent, col. 11, LL. 2-5.
Thus, the stated function is to charge the capacitor to the energy
level indicated by the programming commands received by the device. Essentially,
the function to be accomplished by the "charge control means" in Claim 18 is a
combination of the functions recited in two Claim 1 elements: (1) the "charging
means" element, and (2) the "determining means" element. However, the function
recited in the "charge control means" element of Claim 18 is even more specific
than
-41-
<PAGE>
the "determining means" element in Claim 1 because it explicitly references the
"control information" received from external to the skin of the wearer that
designates a selected magnitude of energy.
The structure associated with the function stated in the claim must be
capable of performing entirely the recited function. Only the physician-operated
embodiment is responsive to "control information" that selects the magnitude of
energy to be used for cardioversion. The cardioverting energy levels in the
patient-operated device are hard-wired and cannot be altered non-invasively
after the device is implanted. In other words, the patient cannot designate a
particular magnitude of energy prior to attempting cardioversion. The patient
can only progress through a series of predetermined energy levels during
repeated attempts at cardioversion. It is neither obvious to one skilled in the
art nor explained in the patent document how the "charge control means" of the
patient-operated device could be "responsive" to the external control
information described in Claim 18. For this reason, the structure associated
with "charge control means" is limited exclusively to the structure identified
and described in reference to the physician-operated embodiment and its
equivalents.
The structure associated with the function of the "charge control
means" in the physician-operated embodiment includes the power inverter (element
52), the comparator (element 100), and the associated circuitry. '472 Patent,
Fig. 1. When switched on, the power inverter delivers energy to the capacitor.
The comparator balances the charge building in the capacitor with the energy
control command. When the voltage across the capacitor equals the voltage
indicated by the energy control command, the comparator produces a "ready"
signal which is sent to the power inverter and
-42-
<PAGE>
turns the power inverter off. At this point, the charging operation is complete.
'472 Patent, col. 6, LL. 26-57. The power inverter delivers energy to the
capacitor, but the comparator ensures that the power inverter stops charging the
capacitor when the voltage reaches the selected magnitude. In this way, the
disclosed structure of the device is "responsive" to the external control
information.
Contrary to St. Jude's proposed construction, however, the ultimate
source of the energy used to charge the capacitor is in no way critical to
accomplishing the function of controlling the charging process to ensure that
the capacitor is charged to the voltage designated in the energy control
command. Again, the external energy source used in the physician-operated
embodiment and the internal battery used in the patient-operated embodiment are
interchangeable sources of the energy for cardioversion disclosed in the patent
document.
The court intends to define "charge control means" as used in Claim 18
of the '472 patent as follows: The "charge control means" are the power
inverter, comparator, and associated circuitry as disclosed in Figure 1 and the
written description of the '472 patent. The accused device infringes this
element of Claim 18 if it uses identical or equivalent structures to ensure that
the capacitor is charged to the magnitude of energy designated in the
programming commands received by the implanted device.
J. '472 CLAIM 18: "SENSING AN ABNORMAL CARDIAC RHYTHM, WHEREIN
CARDIOVERSION IS REQUIRED."
In contrast to the first several disputed elements in Claim 18, the
recited step of "sensing an abnormal cardiac rhythm, wherein cardioversion is
required" is actually a step in the method claim
-43-
<PAGE>
rather than a recitation of components. The parties dispute whether "sensing an
abnormal cardiac rhythm" is a step-plus-function element subject to ss. 112 P.
6. St. Jude argues that ss. 112 P. 6 controls and that the sensing step is
performed by human intervention in both disclosed embodiments of the invention.
Def. Br. at 38. CPI contends that the element recites an act, not subject to ss.
112 P. 6 and that the element should not be confined to "sensing" that involves
human judgment. Pl. Reply Br. at 47-48.
The ss. 112 P. 6 limitations apply to an element in a method claim
"only when steps PLUS FUNCTION without acts are present." O.I. CORP. V. TEKMAR
CO., 115 F.3d at 1583 (emphasis in original). Thus, the initial task is to
determine whether the contested element recites an act or a function. Judge
Rader has provided extensive comments on the often difficult-to-draw distinction
between acts and functions:
[C]laim elements without express step-plus-function language
may nevertheless fall within ss. 112, P. 6 if they merely
claim the underlying function without recitation of acts for
performing that function. Unfortunately, method claim
elements often recite phrases susceptible to interpretation
as either a function or as an act for performing a function.
Both acts and functions are often stated using verbs ending
in "ing." For instance, if the method claim element at issue
in this case had merely recited the "step of" "spreading an
adhesive tack coating," it would not have been clear solely
from this hypothetical claim language whether "spreading" was
a function or an act. In such circumstances, claim
interpretation requires careful analysis of the limitation in
the context of the overall claim and the specification.
In general terms, the "underlying function" of a
method claim element corresponds to WHAT that element
ultimately accomplishes in relationship to what the other
elements of the claim and the claim as a whole accomplish.
"Acts," on the other hand, correspond to HOW the function is
accomplished. Therefore, claim interpretation focuses on what
the claim limitation accomplishes, i.e., it's [sic]
underlying function, in relation to what is accomplished by
the other limitations and the claim as a whole. If a claim
element recites only an underlying function without acts for
performing it, then ss. 112, P. 6 applies even without
express step-plus-function language.
-44-
<PAGE>
SEAL-FLEX, INC. V. ATHLETIC TRACK AND COURT CONSTR., 172 F.3d 836, 849-50 (Fed.
Cir. 1999) (Rader, J., concurring) (emphasis in original).
The preamble of Claim 18 recites the overall purpose of the claimed
method and introduces a series of steps for accomplishing that purpose with the
words "steps of." Such a general statement of purpose in the preamble does not
constitute an associated function for each of the method steps that follow. See
O.I. CORP. V. TEKMAR CO., 115 F.3d at 1583. In addition, functions are more
likely to be introduced by the phrase "steps for" rather than "steps of." See
SEAL-FLEX, 172 F.3d at 850 (Rader, J., concurring). Thus, the language in the
preamble of Claim 18 suggests that ss. 112 P. 6 does not apply. However, the
language of the specific claim element in question - "sensing an abnormal
cardiac rhythm" - recites a step at a very abstract level. Upon encountering the
step of "sensing an abnormal cardiac rhythm," even one skilled in the art could
reasonably ask HOW does the device sense the abnormal cardiac rhythm? The
language of the disputed "sensing" element in this claim provides nowhere near
as much detail as the "passing" steps found to be acts in O.I. CORP. V. TEKMAR
CO. See 115 F.3d at 1579, 1583 ("passing the analyte slug through a passage
heated to a first temperature higher than abient, as the analyte slug passes
from the sparge vessel to the trap" is not a step-plus-function limitation). In
SERRANO V. TELULAR CORP., the Federal Circuit found that the step of
"automatically determining the last-dialed number of the telephone number dialed
on the telephone communications-type device" was an act and not a function. 111
F.3d 1578, 1583 (Fed. Cir. 1997). The "determining" step in SERRANO was actually
a sub-step to a more general step stated in the claim and explains a detailed
point in the claimed method that is simply not comparable to the generic step of
"sensing an abnormal cardiac rhythm."
-45-
<PAGE>
Analyzing the "sensing" limitation in the context of the overall claim
and the specification, the court concludes that the step recites a function
rather than an act, even though the element is not introduced by "step for"
language. First, the "sensing" step obviously is critical to the overall
process. Second, the rest of the language in Claim 18 does not aid construction
of the "sensing" step" by filling in details that would answer the critical
"how" question. Third, the specification discloses specific acts for
accomplishing the sensing function. In light of the need to answer the critical
question of HOW the patentee intended to accomplish the step of "sensing an
abnormal cardiac rhythm," the court concludes that the "sensing" step in Claim
18 is a step-plus-function element controlled by ss. 112 P. 6.
The specification expressly teaches two manual "sensing" methods. In
the physician-operated embodiment of Figure 1 and Figure 2, the external display
and control console receives an ECG signal through an input device. The
physician views a display of the ECG signal and determines the presence of an
abnormal cardiac rhythm. In the patient-operated embodiment, the patient is
taught to recognize the symptoms of arrhythmia based on sensing his or her
heartbeat. Once the patient senses an arrhythmia, he or she places the magnet
over the proper switch on the implanted device.(11)
-----------------------
(11)CPI claims that a second "automatic" sensing process takes place in
the patient-operated
-46-
<PAGE>
The court intends to define "sensing an abnormal cardiac rhythm" as
limited to the disclosed sensing methods of (1) displaying an ECG signal for
observation and interpretation by a physician, or (2) direct observation of the
heartbeat by the physician or patient, or (3) sensing methods equivalent to
method (1) or (2).
K. '472 CLAIM 18: "ELECTRICALLY CARDIOVERTING THE HEART BY
DISCHARGING SAID SELECTED MAGNITUDE OF STORED ENERGY THROUGH
SAID DELIVERY ELECTRODES INTO THE HEART OF THE WEARER."
The step of "electrically cardioverting the heart by discharging said
selected magnitude of stored energy through said delivery electrodes into the
heart of the wearer" is another disputed element of the method stated in Claim
18. However, unlike the step of "sensing an abnormal cardiac rhythm," the
"cardioverting" element recites the acts that accomplish the cardioverting
function. The clause "by discharging said selected magnitude of stored energy
through said delivery electrodes into the heart of the wearer" sufficiently
describes how the heart is cardioverted. Thus, ss. 112 P. 6 does
--------------------------------------------------------------------------------
device. According to CPI, the circuitry in the device "automatically" senses
that an abnormal cardiac rhythm is present "due to the expiration of the time
out period of timer 116 before the magnet is removed by the patient." Pl. Reply
Br. at 47. The court disagrees. The "sensing" done by the timer, if anything, is
sensing the elapse of the time delay and sensing that the magnet is still in
place. If the first shock to the heart corrects the arrhythmia, but the magnet
is left in place and the timer expires, another shock will be delivered to the
heart even though the patient is no longer experiencing arrhythmia.
-47-
<PAGE>
not control this element and there is no basis for limiting the scope of the
claim to the disclosures in the specification. Nonetheless, St. Jude renews its
argument that the patentee has at least implicitly limited the definition of the
word "cardioverting" to the treatment of atrial, and not ventricular,
arrhythmias.
To support the contention that "cardioverting," as used in a step of
the method claim, should be limited to atrial cardioversion, St. Jude cites the
same intrinsic evidence discussed above in Section II-A of this entry. St. Jude
also points out a few additional instances in the specification where the
description discusses atrial arrhythmias or the discharge of cardioverting
energy "in or about the heart, as in the right atrium." '472 Patent, col. 7, LL.
42-43; see also, e.g., col. 6, LL. 2-5 ("the discharge capacitor feeds directly
to a catheter 72 implanted in or about the atrium 74 of a heart"); col. 8, LL.
1-7 ("the discharge capacitor 78 discharges through the heart 76 of the patient
via atrial catheter 72.").
For the reasons discussed in detail above regarding Claim 1, the court
finds that the step of "cardioverting the heart" as used in Claim 18 is not
limited to atrial cardioversion.
III. CLAIM CONSTRUCTION OF THE '191 PATENT
The '191 patent was issued on February 25, 1986, and is closely related
to the '472 patent. The two patents disclose identical embodiments, and the
written descriptions track one another word-for-word with the exception of the
titles, the abstracts, and two statements of purpose that appear only in the
'472 patent. The claims in the two patents differ substantially, of course. CPI
-48-
<PAGE>
asserts that the '191 patent is "directed to the synchronization of a
cardioversion pulse with a repeatable characteristic of the ECG signal (such as
the R-wave)." Pl. Br. at 5. St. Jude describes the scope of the claimed
invention more narrowly: "The invention claimed here has to do with what is
called QRS synchronization, which is a treatment function that is only
applicable to atrial defibrillation." Def. Br. at 38.
The apparatus Claim 1 of the '191 patent reads:
1. A cardioverting device comprising:
detecting means for issuing an electrical signal
representing the actual ECG activity of the heart of
a wearer of the device;
storage means for storing energy to convert an
abnormal cardiac rhythm to normal sinus rhythm;
delivery electrode means for discharging the stored
energy into the heart of the wearer;
switch means for controlling the discharge of the
stored energy into the heart of the wearer;
charging means for delivering to said storage means
said energy to convert the abnormal cardiac rhythm;
first monitoring means for monitoring the operation
of said storage means and issuing a first signal
when said storage means has stored a predetermined
amount of energy;
second monitoring means for monitoring the ECG
signal produced by said detecting means and for
detecting a preselected repeatable characteristic of
the ECG signal, said monitoring means further
including means for issuing a second signal each
time said second monitoring means detects said
preselected repeatable characteristic of the ECG
signal;
third monitoring means for monitoring the ECG signal
produced by said detecting means for activating said
charging means in the presence of abnormal cardiac
rhythm in need of correction; and
-49-
<PAGE>
actuating means connected to said first and second
monitoring means and requiring the simultaneous
presence of said first and second signals at the
time the stored energy is to be delivered to the
heart of the wearer, said actuating means for
actuating said switching means.
'191 Patent, col. 8, L. 56 to col. 9, L. 23.
-50-
<PAGE>
A. '191 CLAIM 1: DISPUTED LANGUAGE SIMILAR TO THE LANGUAGE IN
CLAIM 1 OF THE '472 PATENT
1. '191 CLAIM 1: "A CARDIOVERTING DEVICE"
The dispute over the scope of the word "cardioverting" reappears in
Claim 1 of the '191 patent. As discussed above in Section II-A, the court
rejects St. Jude's proposed construction, which would limit the claim to an
atrial device.
2. '191 CLAIM 1: OTHER ELEMENTS CONSTRUED IDENTICALLY TO
THEIR '472 CLAIM 1 COUNTERPARTS
The parties generally agree that the following elements appearing in
Claim 1 of the '191 patent present interpretation issues identical, or nearly
identical to those presented in the construction of disputed terms in Claim 1 of
the '472 patent: (1) "storage means for storing;" (2) "delivery electrode means
for discharging;" and (3) "charging means for delivering to said storage means
said energy." The court has independently considered the claim language,
relevant intrinsic evidence, and arguments of the parties in reaching a
conclusion with respect to construction of these elements in the '191 patent.
The court intends to define each of these elements in a manner identical to the
manner in which the corresponding elements in Claim 1 of the '472 patent have
been defined above. Thus, for the sake of simplicity, the court simply refers
back to the reasoning and claim construction as stated in Sections II-B, II-C,
and II-D.
-51-
<PAGE>
B. '191 CLAIM 1: "THIRD MONITORING MEANS"
The final dispute over the language in Claim 1 of the '191 patent
concerns the element that identifies a "third monitoring means for monitoring
the ECG signal produced by said detecting means for activating said charging
means in the presence of abnormal cardiac rhythm in need of correction." Both
sides agree that the element is in means-plus-function format, but they disagree
as to the proper interpretation of the element under ss. 112 P. 6. By separate
order today, THE court is scheduling a further hearing on this element.
IV. CLAIM CONSTRUCTION OF THE '288 PATENT
The third patent in suit, the '288 patent, was issued October 4, 1983.
It relates to a device capable of detecting abnormal heart activity, selecting
the appropriate therapy, and then executing the therapy so as to treat the
determined condition. Operations carried out by the implantable heart stimulator
include cardiac pacing, cardioversion, and automatic defibrillation. '288
Patent, Abstract.
The parties' claim construction disputes relate to Claim 1, a method
claim, and Claim 10, an apparatus claim. The claims read:
1. A method of heart stimulation using an implantable heart
stimulator capable of detecting a plurality of arrhythmias and
capable of being programmed to undergo a single or multi-mode
operation to treat a detected arrhythmia, corresponding to
said mode of operation the method comprising the steps of:
(a) determining a condition of the heart from among a
plurality of conditions of the heart;
-52-
<PAGE>
(b) selecting at least one mode of operation of the
implantable heart stimulator which operation includes
a unique sequence of events corresponding to said
determined condition; and
(c) executing said at least one mode of operation of said
implantable heart stimulator thereby to treat said
determined heart condition.
'288 Patent, col. 21, LL. 9-23.
10. An implantable heart stimulator capable of monitoring and
detecting a plurality of arrhythmias, and capable of being
programmed to undergo a single or multi-mode of operation
corresponding to a respective arrhythmia to treat
automatically the detected arrhythmia, said stimulator
comprising:
determining means for determining the occurrence of one of a
plurality of conditions of the heart;
selecting means responsive to said determining means for
selecting at least one mode of operation of said implantable
heart stimulator corresponding to a respective one of said
plurality of conditions for automatically treating said
determined conditions; and
executing means for executing a sequence of events defined by
said at least one mode of operation, whereby to treat said
determined condition.
'288 Patent, col. 22, LL. 10-26. The terms and phrases used in these two claims
overlap. The court first analyzes a disputed phrase that appears in the
preambles of both Claim 1 and Claim 10, then proceeds to the apparatus elements
of Claim 10, and then returns to Claim 1 to construe disputed terms in the
method steps.
A. '288 CLAIM 1 & '288 CLAIM 10: "SINGLE OR MULTI-MODE OPERATION"
Claim 1 of the '288 patent refers to an implantable heart stimulator
"capable of being programmed to undergo a single or multi-mode operation to
treat a detected arrhythmia." CPI proposes that the term "multi-mode operation
to treat a detected arrhythmia" be construed to mean:
-53-
<PAGE>
"two or more different modes of therapy (e.g., antitachy pacing and
cardioversion) capable of being used in sequence to treat a single arrhythmia
(e.g., tachycardia)." Pl. Amd. Prop. Conc. of Law at 1. St. Jude objects to
CPI's definition because it includes unnecessary examples and because the phrase
"capable of being used in sequence" is claimed to be inaccurate, or at least
imprecise. St. Jude offers the following as the proper construction:
The phrase "multi-mode operation to treat a detected
arrhythmia" as used in claims 1 and 10 of the '288 patent
means two or more different modes of therapy capable of being
used individually to treat a single arrhythmia.
Def. Prop. Conc. of Law at 8.
To begin by defining the term "mode" as used in Claim 1, the patent
specification reveals that the operating modes of the device include various
treatment modes, or therapies, that can be applied to the heart in the event of
an arrhythmia.(12) Each type of therapy, or mode, involves some form of
electrical stimulation of the heart. The specification identifies the following
treatment modes: ventricular fixed-rate pacing, atrial fixed-rate pacing,
ventricular demand pacing, bifocal pacing, automatic defibrillation,
cardioversion, and various automatic ventricular tachycardia control operations.
'288 Patent, col. 4, LL. 21-27; col. 4, L. 65 to col. 5, L. 3.
Referring again to the claim language itself, the device is said to be
"capable of being programmed to undergo a single or multi-mode operation to
treat a detected arrhythmia." The plain
-----------------------
(12)Besides the various treatment modes, other operating modes include
the "automatic patient warning" feature and the "direct memory access" mode.
'288 Patent, col. 4, ll. 67-68; col. 5, ll. 5-8.
-54-
<PAGE>
meaning of this language is that the device can be programmed to treat any
particular arrhythmia using either ONE mode of operation, or MORE THAN ONE mode
of operation. If the device is programmed to treat an arrhythmia using one mode
of operation, it will "undergo a single . . . mode operation." If the device is
programmed to treat an arrhythmia using more than one mode of operation, it will
"undergo a . . . multi-mode operation."
The specification provides a clear example of "multi-mode operation" in
explaining the automatic ventricular tachycardia control operations:
In this mode, any combination and/or sequence of the
following sub-modes can non-invasively be selected
(programmed) by the attending physician: ventricular
overdrive pacing, ventricular coupled pacing, automatic
cardioversion, and rapid atrial pacing. Any or all of these
can be selected, so that, if the first response is not
effective in controlling ventricular tachycardia, the next
response is activated. That is, initially, a list associated
with the various modes can be developed; then, the doctor can
revise the list depending on the patient's reaction to
treatment.
'288 Patent, col. 5, LL. 33-43.(13) The specification further explains that in
executing such automatic ventricular tachycardia control operations, the device
automatically proceeds from one response mode to the next. '288 Patent, col. 5,
LL. 50-52. This specific example is consistent with the more general description
of the invention that appears in the patent document. See '288 Patent, col. 7,
LL. 7-12 ("The implantable heart stimulator and method involve . . . the
choosing of AT LEAST ONE mode of treatment for treating the condition.")
(emphasis added). Together, the claim language and the
-----------------------
(13)Another example of "multi-mode operation," closely associated with
dependent Claim 8, involves a method for treating the heart when the device
detects the absence of a natural R-wave. '288 Patent, col. 21, L. 55 to col. 22,
L. 6. The absence of an R-wave could indicate either an asystole (treatable by
pacing), or life-threatening ventricular fibrillation. Under such conditions,
the device first executes a pacing treatment. If the pacing therapy does not
restore a forced R-wave, the device then attempts defibrillation. '288 Patent,
col. 2, L. 66 to col. 3, L. 5.
-55-
<PAGE>
specification provide strong support for CPI's proposed construction of
"multi-mode operation to treat a detected arrhythmia."
St. Jude's characterization of CPI's proposed construction as an
improper "limitation" on the claim has no merit. According to St. Jude, the
specification and the prosecution history provide no support for claiming that
"multiple modes" could be used only in sequence. Def. Br. at 44. Under this
view, which is reflected in St. Jude's preferred construction, the device has
more than one treatment mode that could be used to treat each specific heart
condition (thus, multiple modes), but a single mode is selected from among the
multiple possibilities and programmed as the individual mode that will treat a
given arrhythmia. Such individually selected modes, defendants argue, would not
be executed in sequence and, thus, an "in sequence" limitation would be
improper. ID. at 44-45 & n.22.
St. Jude may well be correct that a single mode of treatment can be
programmed to treat a given arrhythmia even though the device is capable of
executing different modes to treat that same arrhythmia. However, this
possibility is already accounted for in the claim language that refers to
programming a device to undergo a "single" mode operation. Multi-mode operation,
as taught by both the claim language and the specification, is different. It
involves programming the device to UNDERTAKE more than one treatment mode to
treat a single arrhythmia, especially if the first mode is not successful. St.
Jude's preferred construction would effectively re-write the language of the
claim to read "a heart stimulator providing at least one treatment mode for each
specific heart condition and capable of being programmed to undergo the single
available mode, or, if applicable, one of the
-56-
<PAGE>
multiple available modes to treat the detected arrhythmia." That interpretation
is contrary to the claim language and the written description.
St. Jude offers a proposed alternate construction in an attempt to save
at least part of its preferred construction:
The phrase "multi-mode operation to treat a detected
arrhythmia" as used in claim 1 of the '288 patent means two
or more different modes of therapy capable of being used
individually or together in sequence to treat a single
arrhythmia.
Def. Br. at 41. The court rejects this construction because it is unnecessarily
complex and confusing. The possibility that a device may offer more than one
treatment mode for a single arrhythmia but may be programmed to undertake only
one of those modes is accounted for by the fact that the claim language already
allows a device to be programmed for single mode operation. Thus, St. Jude's
construction of "multi-mode operation" to encompass two or more modes "capable
of being used individually" repeats what is already stated in the claim.
St. Jude's final argument on this language is that it would be improper
for the court to include the examples of treatment modes and heart conditions
that plaintiffs have selected and included in their claim construction. The
court agrees that using examples is unlikely to be necessary. By the end of the
trial, the jurors should be able to identify for themselves (at least with the
help of counsel) appropriate examples of treatment modes and different types of
arrhythmia. The court, therefore, intends to adopt plaintiffs' proposed
construction of "multi-mode operation" with the exception of the parenthetical
examples. This interpretation of the language in the preamble of
-57-
<PAGE>
Claim 1 of the '288 patent will also apply to the disputed parallel language in
the preamble of Claim 10 of the '288 patent.
-58-
<PAGE>
B. '288 CLAIM 10: "DETERMINING MEANS FOR DETERMINING THE
OCCURRENCE OF ONE OF A PLURALITY OF CONDITIONS OF THE HEART"
The first apparatus element in Claim 10 identifies "determining means
for determining the occurrence of one of a plurality of conditions of the
heart." The parties agree that ss. 112 P. 6 governs this language. They do not
agree on the structures that perform the functions of detecting various heart
conditions (e.g., normal heart rhythm, ventricular fibrillation, low-rate
tachycardia, and super-ventricular tachycardia) and distinguishing them from one
another.
An understanding of two types of detection circuitry is essential
background information to the parties' dispute over the "determining means"
element of the '288 patent. First, there is rate detection circuitry. A rate
detector is capable of determining whether the heart rate is above or below a
set threshold rate. Thus, if the threshold rate is set at 50 beats per minute, a
rate circuit's output tells the device that the heart rate is either less than
50 beats per minute or greater than 50 beats per minute. It does not return an
exact measurement of the heart rate. In other words, if the threshold rate is 50
beats per minute, the rate circuit cannot differentiate between 75, 100, or 200
beats per minute. It can only tell that the rate is greater than 50 beats per
minute. Kroll Decl. P. 6. However, by using a combination of two or more rate
detectors, a device can differentiate among various ranges of heart rates. For
example, if one rate detector were set at 50 beats per minute and another at 150
beats per minute, one could determine when the heart rate is (1) less than 50
beats per minute, (2) between 50 and 150 beats per minute, or (3) greater than
150 beats per minute. The greater number of rate detectors used, the greater
number of heart rate ranges that can be distinguished.
-59-
<PAGE>
A second type of detection circuitry is based on probability density
function (PDF) analysis of the ECG voltage. PDF circuitry determines the
fraction of time, on the average, that the ECG signal spends between two
amplitude limits. For a normal heart condition, the voltage stays near zero most
of the time and jumps up only at the start of the heartbeat (seen as a blip on
the patient monitor). When a heart is fibrillating, however, the voltage
fluctuates chaotically between positive and negative extremes. The PDF circuitry
essentially uses the PDF measurements to "profile" the condition of the heart.
See Ex. 121, '493 Patent, col. 3, LL. 14-24 (discussed below); Kroll Decl. P. P.
4-6.
The diagrams and the written description of the '288 patent identify a
"dedicated cardiac state evaluation circuit 34." '288 Patent, Fig. 2A, element
34; col. 9, L. 59 to col. 10, L. 18. Circuit 34 generates binary outputs which
are then analyzed to determine the condition of the heart. Each combination and
permutation of binary outputs corresponds to a particular heart condition. The
device is programmed to associate each particular heart condition with a
treatment regimen. It is possible to generate the binary outputs described in
the specification using a combination of rate and PDF circuitry in circuit block
34. However, it is also possible to use multiple rate circuits, without any PDF
circuitry, to detect the various heart arrhythmias. These alternative possible
means for detecting the condition of the heart give rise to the parties' dispute
over the "determining means" element.
St. Jude argues that the "determining means" of Claim 10 "requires a
structure that utilizes, at least in part, a PDF analysis of the ECG signal for
performing the function of determining the occurrence of one of a number of
possible conditions of the patient's heart." Def. Br. at 53. This
-60-
<PAGE>
construction would exclude "determining means" based on the use of multiple rate
detectors WITHOUT PDF circuitry. St. Jude claims that this is the proper
construction because the patent specification does not disclose that heart rate
alone could be used. CPI contends that the structure corresponding to
"determining means" is EITHER rate detection circuitry OR PDF circuitry. In
CPI's view, the fact that the specification refers to each type of detection
circuitry is more important than the fact that it also discloses them as being
used together.
Under ss. 112 P. 6 , of course, the court or other readers must turn to
the specification to learn what structure performs the function of determining
the heart's condition. The critical section of the specification describes both
the function and structure of the dedicated cardiac state evaluation circuit 34:
Dedicated cardiac state evaluation circuit 34 also generates,
in response to detection of particular cardiac states,
corresponding outputs indicating the occurrence of the
particular state, that is to say, output FIB (indicating
fibrillation), output TACHY (indicating tachycardia), and
output BRADY (indicating bradycardia). The latter three
outputs are provided to input selector 36.
More specifically, the dedicated cardiac state
evaluation circuit 34 comprises CIRCUITRY SIMILAR TO THE
HEART RATE CIRCUITRY CONTAINED IN THE ARRHYTHMIA DETECTION
SYSTEM DISCLOSED IN COPENDING APPLICATION SER. NO. 175,670
FILED ON AUG. 5, 1980 AND FIBRILLATION DETECTION CIRCUITRY AS
IN PAT. NO. 4,184,493 of Langer et al.
'288 Patent, col. 9, L. 59 to col. 10, L. 8 (emphasis added). The quoted
excerpt, read in light of the two public documents incorporated by reference,
shows that circuit block 34, the disclosed "determining means," uses both rate
and PDF detection circuitry.
-61-
<PAGE>
Patent application Ser. No. 175,670 was a parent application to Pat.
No. 4,475,551 ("the '551 patent") and is incorporated by reference into the
written description of circuit 34. The '551 patent discloses an arrhythmia
detection system that uses rate detection circuitry in conjunction with PDF
analysis to eliminate a problem with "false positives" that occurred when PDF
analysis, used alone, failed to distinguish between fibrillation and high rate
tachycardia, on the one hand, and low rate tachycardia, on the other hand. Ex.
122, '551 Patent, col. 2, LL. 24-40, 43-60. The false positives caused devices
to deliver a defibrillating shock to the heart when it was not appropriate to do
so. ID. The '551 patent discloses two specific types of rate detecting circuits.
'551 Patent, Figs. 2 & 5. Used in conjunction with PDF circuitry, these rate
circuits are designed to distinguish more accurately among various arrhythmias.
The second document incorporated by reference into the '288 description
of circuit block 34 describes how PDF analysis is a superior means of detecting
ventricular fibrillation. '493 Patent, col. 2, L. 67 to col. 3, L. 16 ("The
inventive detector enjoys operation independent from the concepts of QRS
detection and heart rate calculations to maximize accuracy. . . . The inventive
[ventricular fibrillation] detector depends . . . upon . . . the principle of
probability density function."). The '493 patent describes solely the use of PDF
circuitry as a means of detecting ventricular fibrillation.
The significant point to draw from the '551 and '493 patents is that
both documents disclose means for detecting arrhythmias that include the use of
PDF circuitry. Neither discloses structure for detecting and differentiating
among abnormal heart conditions WITHOUT the use of PDF circuitry. That fact
weighs in favor of a construction of "determining means" that requires PDF
analysis, as St. Jude contends.
-62-
<PAGE>
CPI counters with two arguments to bolster its favored construction of
"determining means," which would allow for solely rate-based detection. CPI
first contends that the '288 patent's reference to the rate detection circuitry
disclosed in the '551 patent indicates that the inventors "disclosed multiple
ways for achieving the results." However, the '551 patent contains no language
suggesting either that PDF analysis is an optional component of the disclosed
arrhythmia detection system, or that heart rate analysis is independently
sufficient to perform the determining function. In fact, the '551 patent
document refers to the inventive use of rate detection as "a 'backup' technique
by means of which high rate tachycardia is treated by issuance of a
defibrillating shock to the patient." '551 Patent, col. 2, LL. 37-40. In the two
disclosed embodiments of the '551 patent, the rate circuits are shown to
"backup" PDF circuits. '551 Patent, Figs. 1 & 4. Moreover, in describing the
structure of dedicated cardiac state evaluation circuit 34, the '288
specification uses the conjunction "and" to state that circuit 34 comprises
circuitry similar to both the '551 patent AND the '493 patent. This language
gives no indication that rate circuitry and PDF circuitry are interchangeable
alternatives.
CPI's second argument is based on the prosecution history, including
the fact that the patent examiner cited prior art that used rate detection
circuitry and the fact that a patent term extension was granted based on a
device that uses rate-based detection. While the prosecution history supports
CPI's argument that rate-based detection is part of the '288 patent's disclosed
arrhythmia detection system, it is not sufficient to overcome the fact that the
only structures disclosed in the '288 patent document also use PDF analysis.
Having elected to phrase the claim in means-plus-function form,
-63-
<PAGE>
CPI cannot use the prosecution history to broaden the claim beyond what is
disclosed in the specification.
The court intends to define the term "determining means," as used in
Claim 10 of the '288 patent, as follows:
The '288 patent specification discloses a "dedicated cardiac
state evaluation circuit 34" to perform the function of
determining the occurrence of one of a plurality of
conditions of the heart. The dedicated cardiac state
evaluation circuit, in turn, is comprised of both heart rate
circuitry and probability density function (PDF) circuitry.
Therefore, "determining means" requires an arrhythmia
detection structure that is identical or equivalent to the
disclosed use of both heart rate circuitry and PDF circuitry.
The parties' dispute as to whether the disclosed structure either forecloses or
allows an arrhythmia detection system that uses only rate-based circuits is an
equivalency argument they will have to make to the finder of fact.
C. '288 CLAIM 10: "EXECUTING MEANS FOR EXECUTING A SEQUENCE OF
EVENTS DEFINED BY SAID AT LEAST ONE MODE OF OPERATION, WHEREBY
TO TREAT SAID DETERMINED CONDITION"
Both parties agree that ss. 112 P. 6 controls this claim. The parties'
dispute over "executing means" requires the court to identify the disclosed
structure that performs the stated function of "executing a sequence of events
defined by said at least one mode of operation, whereby to treat said determined
condition."
The "executing" function occurs after the device has identified the
arrhythmia that is present in the heart and after it has matched the arrhythmia
to the appropriate treatment sequence. The various treatment sequences are
stored as programs in program memory 44 and may involve a
-64-
<PAGE>
single-mode operation or a multi-mode operation. The patent specification
indicates that microprocessor 40 "responds to successive op codes from the
program memory 44 so as to execute the program corresponding to the desired
treatment (pacing, cardioversion, defibrillation, and so forth)." '288 Patent,
col. 12, LL. 61-65.
CPI argues that because microprocessor 40 executes the program
corresponding to the desired treatment, microprocessor 40 is the structure
associated with the "executing means" element. However, the claim language
indicates that the structure executes a sequence of events "whereby to treat
said determined condition." '288 Patent, col. 22, LL. 24-26. Thus, after the
device has completed the executing function, the claim indicates that the heart
should have received the treatment (if appropriate). Microprocessor 40 alone
cannot perform the entire "executing" function as stated in the claim. It is
part of the executing process, but additional structure is involved in executing
the sequence of events defined by the selected mode (or modes) of operation.
"Output stage 22" is further structure disclosed in the specification
that is essential to the "executing" function. '288 Patent, Figs. 1 & 5. Output
stage 22 includes the following structure: inverter 62, pulse generator 64,
atrial pacer drive circuit 66, ventricular pacer drive circuit 68, and patient
warning circuit 70. '288 Patent, col. 17, LL. 12-16. Output stage 22 receives
control outputs generated by, for example, microprocessor 40, and responds by
performing the tasks indicated by the control outputs. See, e.g., '288 Patent,
col. 17, LL. 17-32 (explaining how the output stage responds when it receives
the "START DEFIB" signal generated by microprocessor 40); col. 10, LL. 36-54
(describing the sequence of events that is initiated in response to detection of
a ventricular
-65-
<PAGE>
fibrillation condition). Because output stage 22 is structure necessary to
perform the "executing" function stated in the claim, the court rejects CPI's
proposed construction of this claim language.(14)
-----------------------
(14)CPI's proposed construction is also faulty because it identifies
only one of two microprocessors responsible for generating control outputs that
control the release of energy into a patient's heart. The specification teaches
a preference for the use of dual processors for executing various treatment
programs. '288 Patent, col. 4, L. 3 to col. 5, L. 9. Thus, microprocessor 40 has
a counterpart, microprocessor 56. Microprocessor 40 generates control outputs
such as "START DEFIB" (indicating the need for defibrillation), "AP1"
(indicating the need for atrial pacing), and "VEP1" (indicating the need for
ventricular pacing). '288 Patent, col. 14, L. 59 to col. 15, L. 10.
Microprocessor 56 generates outputs including "AP2" (indicating the need for
atrial pacing) and "VP2" (indicating the need for ventricular pacing). '288
Patent, col. 15, LL. 61-68. Which element controls the atrial or ventricular
pacing depends on the particular type of pacing to be performed. As explained in
the specification:
[T]he microprocessor 40 (FIG. 3A) operates in conjunction
with the output latch 52 to implement atrial and ventricular
pacing involving long-term, relatively simple procedures.
Conversely, the microprocessor 56 (FIG. 4) handles atrial and
ventricular pacing involving short-term, relatively more
complicated procedures.
'288 Patent, col. 17, L. 59 to col. 18, L. 5.
-66-
<PAGE>
St. Jude's proposed construction of this element reads as follows:
The "executing means" of claim 10 of the '288 patent requires
the execution of a sequence of events defined by the selected
mode of operation without regard to the patient's history and
includes the acts of charging a capacitor from an energy
source, such as a battery, and applying the accumulated
charge to the patient's heart in order to treat the
determined heart condition.
Def. Br. at 54. The court rejects this construction for three reasons. First, it
fails to link the function stated in the claim with its associated structure as
disclosed in the specification, which is the point of interpretation under ss.
112 P. 6. Rather than defining the structure, St. Jude's construction focuses on
acts - a construction more appropriate for a method claim. Second, the phrase
"without regard to the patient's history" adds a limitation that is unrelated to
the "executing means" element. As the claim language itself indicates, selecting
the appropriate treatment and the criteria upon which that decision is based is
a function separate from executing the treatment thereby selected. Third, the
claim language does not limit the "sequence of events" performed in the
executing stage to the steps of charging a capacitor and applying the charge to
the heart. Executing the mode (or modes) of operation identified with a
particular detected heart condition may involve more than the ultimate event of
applying a charge to the heart. For example, the specification indicates that
when the device detects ventricular fibrillation, one of the events that is
performed prior to applying a defibrillating shock to the heart is that the
pacing circuits are shut down. '288 Patent, col. 10, LL. 36-54.
The court intends to define the "executing means" element of Claim 10
by explaining the recited function and by identifying the structure that the
specification associates with that function:
-67-
<PAGE>
The function of the "executing means" in Claim 10 of the '288
patent is to perform the sequence of events associated with
each mode of operation that has been selected to treat the
identified arrhythmia.
The "executing means" disclosed in the '288 patent are the
following structures: (1) the microprocessors and associated
circuitry that translate programming associated with the
desired treatment into output command signals, and (2) the
structures comprising output stage 22 that respond to the
command signals and perform the desired treatment, as
diagramed in Figure 5 of the '288 patent and described in the
specification.
The accused devices infringe the "executing means" element if
they include identical or equivalent structure for performing
the stated function.
D. '288 CLAIM 1: "DETERMINING A CONDITION OF THE HEART FROM AMONG
A PLURALITY OF CONDITIONS OF THE HEART"
Returning now to Claim 1 of the '288 patent, the first method step
recited is the step of "determining a condition of the heart from among a
plurality of conditions of the heart." The court must determine whether ss. 112
P. 6 applies to this method step, and if so, whether the specification limits
the claim to determining the condition of the heart by using, at least in part,
probability density function (PDF) analysis of the ECG signal. The court finds
that ss. 112 P. 6 controls this claim element and that the element is limited to
detecting and distinguishing among arrhythmias by analyzing the outputs of rate
circuitry and PDF circuitry.
CPI argues that because Claim 1 of the '288 patent uses "steps of"
rather than "steps for" to introduce the three recited method steps, there is a
presumption that ss. 112 P. 6 does not apply. See SEAL-FLEX, 172 F.3d at 850
(Rader, J., concurring). CPI further contends that the language of the
"determining" claim element recites an act and not a function. The court does
not agree.
-68-
<PAGE>
The claim element uses extremely broad language. A simple question
arises: If the step of "determining a condition of the heart" is not limited by
the disclosures, how is it limited at all? CPI asserts in its brief: "The step
of 'determining a condition of the heart' carries no limitations in the claim
language as to the manner or way in which the condition is detected, and none
can be properly read into the claim language." Pl. Br. at 22. However, allowing
CPI to claim all possible methods of detecting heart arrhythmia sweeps too
broadly. The court is mindful that not all claims using gerunds should be
construed as functions. Nonetheless, comparing the "determining step" at issue
here to the claim elements that avoided ss. 112 P. 6 in O.I. CORP. V. TEKMAR CO.
and SERRANO V. TELULAR CORP., the court finds that CPI needed to remove at least
one level of abstraction from its claim. For example, if the step were phrased
in terms of "determining a condition of the heart by analyzing the output
signals generated by heart status detection circuitry to distinguish among
various conditions of the heart," the element would come much closer to stating
HOW the function of determining a condition of the heart is performed. Although
patentees may wish to state claims as broadly as possible, they run the danger
of reaching the boundaries established by ss. 112 P. 6. "Determining a condition
of the heart" crosses the line.
The court intends to construe the claim element as follows:
"'Determining a condition of the heart from among a plurality of conditions of
the heart' means detecting the current condition of the heart and
differentiating among various arrhythmias by analyzing the outputs generated by
a cardiac state evaluation circuit comprising heart rate circuitry and PDF
circuitry." CPI is free to pursue as an equivalency argument its contention that
a person of skill in the art would "know that evaluation
-69-
<PAGE>
circuit 34, broadly described in the '288 patent, could be configured to provide
the FIB, TACHY and BRADY outputs without using PDF." See Pl. Reply Br. at 17.
E. '288 CLAIM 1: "SELECTING AT LEAST ONE MODE OF OPERATION OF THE
IMPLANTABLE HEART STIMULATOR WHICH OPERATION INCLUDES A UNIQUE
SEQUENCE OF EVENTS CORRESPONDING TO SAID DETERMINED CONDITION"
The second step recited in Claim 1 is the step of "selecting at least
one mode of operation of the implantable heart stimulator which operation
includes a unique sequence of events corresponding to said determined
condition." St. Jude contends that the claim language dictates the following
limitation:
The step of "selecting at least one mode . . .[corresponding]
to said determined condition" of claim 1 of the '288 patent
requires that the selection of a mode of operation be based
on the currently determined condition of the heart without
regard to any previously determined condition of the heart.
Def. Prop. Conc. of Law at 9. CPI contends that the "selecting step" is an act,
not a function, and that St. Jude's proposed narrowing limitation is not
warranted by the language of the claim.
St. Jude's proposed construction of the claim language is derived from
the decision criteria involved in "selecting at least one mode of operation."
According to St. Jude, the '288 patent "discloses a system in which the
treatment mode is totally independent of history and is a function only of the
current detected condition." Def. Br. at 52.(15) The court agrees with St.
Jude's contention
-----------------------
(15)St. Jude bases its construction of the "selecting" element
primarily on an amendment to the claim language made during the prosecution of
the patent that added the phrase "unique sequence of events." See Def. Br. at
51-52, citing Ex. 123, '288 Pros. Hist., at 2, 8-9. The court does not fully
agree with St. Jude's analysis of the prosecution history. Had the claim
language or the written
-70-
<PAGE>
that the currently determined condition of the heart is the only variable that
affects the step of "selecting."
The language of the "selecting" step states that the device selects an
operation (consisting of at least one mode) "corresponding to said determined
condition" of the heart. The phrase "corresponding to" does not by itself
foreclose the possibility that the device considers variables in addition to the
currently determined condition of the heart. However, the remainder of the claim
language and the written description indicate that "corresponding to" should be
interpreted to indicate that the selection of an operation is based solely on
the currently determined condition of the heart.
First, the claim language states that the selected operation
corresponds to "said determined condition." The determined condition, as defined
through the determining step in Claim 1, is the result of an evaluation of the
current condition of the heart. The evaluation process involves using rate and
PDF circuitry to detect the presence of various arrhythmias and to differentiate
those arrhythmias from one another. Nothing other than assessing the current
condition of the heart is involved in the determining step.
--------------------------------------------------------------------------------
description suggested that the step of "selecting at least one mode" was a
function of a variable in addition to the determined condition of the heart, the
phrase "unique sequence of events" would not limit the claim as suggested by St.
Jude.
-71-
<PAGE>
Second, the written description explains how the selecting step is
accomplished without ever suggesting that any additional variable affects the
selection process. The "at least one mode of operation" is selected by matching
the output of the "determining" step (i.e., a current heart condition in need of
treatment) to the corresponding treatment. In greater detail, the matching
process involves programming the device so that a particular treatment,
consisting of one or more modes, is associated with each detected heart
condition. A section of program memory contains the instructions for carrying
out the sequence of events necessary to execute each treatment operation. Then,
when a particular heart condition is detected, the device selects the proper set
of instructions (i.e., the unique sequence of events of the treatment operation)
by matching the determined heart condition to the area of the program memory
that contains the program for treating that heart condition. '288 Patent, col.
12, LL. 11-65; Fig. 3B. At the step of selecting the treatment mode, the only
relevant variable is the currently determined heart condition.
In summary, if the patentee intended to claim a method of selection
involving criteria other than the currently determined condition of the heart,
the claim language and the patent specification fail to provide adequate notice
of this intent. See ATHLETIC ALTERNATIVES, INC. V. PRINCE MANUFACTURING, INC.,
73 F.3d 1573, 1581 (Fed. Cir. 1996) ("Where there is an equal choice between a
broader and narrower meaning of a claim, . . . we consider the notice function
of the claim to be best served by adopting the narrower meaning."). The court
intends to define the "selecting" step in method Claim 1 as follows:
The step of "selecting at least one mode of operation of the
implantable heart stimulator which operation includes a
unique sequence of events corresponding to said determined
condition" involves matching the currently determined heart
condition to the unique set of instructions that have been
programmed to treat the
-72-
<PAGE>
detected condition. The treatment operation selected by the device is
determined exclusively by the currently determined condition of the
heart.(16)
F. '288 CLAIM 1: "EXECUTING SAID AT LEAST ONE MODE OF OPERATION
OF SAID IMPLANTABLE HEART STIMULATOR THEREBY TO TREAT SAID
DETERMINED HEART CONDITION."
The last claim element in need of construction is the step of
"executing said at least one mode of operation of said implantable heart
stimulator thereby to treat said determined heart condition." St. Jude asserts
that the claim is stated in functional language subject to ss. 112 P. 6 and
provides the following proposed construction:
The step of "executing said at least one mode . . . [to]
treat said determined heart condition" of claim 1 of the '288
patent requires that a capacitor be charged from an energy
source, such as a battery, with the accumulated charge then
applied to the patient's heart in order to treat the
determined heart condition.
Def. Prop. Conc. of Law at 9. CPI contends that the "executing" element of Claim
1 is not subject to the step-plus-function rules of construction and that the
step should be construed to mean "performing the programmed operation for the
particular detected heart arrhythmia in order to treat it." Pl. Prop. Conc. of
Law at 3.
-----------------------
(16)The court acknowledges that the physician may consider factors
other than the currently determined condition of the heart when programming a
device. However, at the point where a device ITSELF detects an arrhythmia and
selects a treatment mode to execute, no other variables are at work.
-73-
<PAGE>
Regardless of whether this claim element is treated as an act or a
function, the court finds that defendants' proposed construction portrays an
incomplete picture of the executing process by placing undue emphasis on the
acts of charging a capacitor and applying the charge to the heart. As explained
in the discussion of Claim 10, the executing process involves executing the
program corresponding to the desired treatment. Several discrete events often
make up the entire treatment operation. For example, the specification explains
in detail all of the steps involved in executing the treatment associated with
ventricular fibrillation. In addition to building up a charge and issuing a
shock to the patient's heart, the device shuts down the pacing circuits, checks
the treatment parameters stored in a parameter memory, and determines whether or
not the pulse generator is synchronized. See '288 Patent, col. 10, LL. 37-63.
Because the step of "executing said at least one mode of operation"
involves performing multiple events which differ from one treatment mode to the
next, the court does not find it appropriate to catalogue all possible events,
or some subset of events, that are part of the "executing" process. Neither the
claim language nor the specification emphasizes particular events over others.
The material aspect of the executing step is that the device performs the
programmed operation that was specifically selected to treat the determined the
condition of the heart. By executing the appropriate programmed operation, the
device treats the heart.
Assuming that ss. 112 P. 6 governs this element, the court is required
to specify the disclosed act (or acts) that performs the step of "executing said
at least one mode of operation." CPI's proposed construction adequately defines
the disclosed act. Therefore, the court intends to interpret the executing step
as follows:
-74-
<PAGE>
"Executing said at least one mode of operation" means
performing the programmed operation that has been designated
to correspond to the particular heart arrhythmia in order to
treat it.
This construction adequately indicates that "said at least one mode of
operation" is executed by performing the programmed sequence of events
associated with the selected operation.
CONCLUSION
The court intends to interpret the disputed elements of the '472, '191,
and '288 patents as indicated in this Entry.
Date: November 29, 2000
-----------------------------------------
DAVID F. HAMILTON, JUDGE
United States District Court
Southern District of Indiana
-75-
<PAGE>
Copies to:
James Hughes Jay G. Taylor
Sommer & Barnard Ice Miller
111 Monument Circle One American Square
4000 Bank One Tower Box 82001
Indianapolis, IN 46204 Indianapolis, Indiana 46282
David T. Kasper Jeffrey M. Olson
Locke Reynolds, LLP Lyon & Lyon
201 North Illinois Street 633 West Fifth Street, Suite 4700
Suite 1000 Los Angeles, California 90071
P.O. Box 44961
Indianapolis, IN 46244-0961
Timothy J. Malloy
McAndrews Held Malloy, Ltd.
Northwest Atrium Center
34th Floor
500 West Madison Street
Chicago, IL 60661
John R. Schaibley, III
Baker & Daniels
300 North Meridian Street
Suite 2700
Indianapolis, IN 46204
Dennis J. Block
Cadwalader Wickersham & Taft
100 Maiden Lane
New York, NY 10038
Michael Rackman
Gottlieb Rackman & Riesman
270 Madison Avenue
8th Floor
New York, NY 10016
Dennis R. Salmon
Gibson Dunn & Crutcher
1530 Page Mill Road
Palto Alto, CA 94304
-76-
