Medtronic, Inc. v. Guidant Corporation

Error: Bad annotation destination United States Court of Appeals for the Federal Circuit 05-1515 MEDTRONIC, INC., Plaintiff-Appellant, v. GUIDANT CORPORATION, GUIDANT SALES CORPORATION and ELI LILLY & COMPANY, Defendants-Appellees, and MIROWSKI FAMILY VENTURES L.L.C., Defendant-Appellee.

Kenneth C. Bass, III, Sterne, Kessler, Goldstein & Fox , P.L.L.C, of Washington, DC, argued for plaintiff-appellant. With him on the brief was Jon E. Wright.

Arthur I. Neustadt, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., of Alexandria, VA, for Mirowski Family Ventures L.L.C., argued for all defendants- appellees. With him on the brief for Guidant Corporation, et al. were J. Michael Jakes, Kathleen A. Daley, and Naveen Modi, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P, of Washington. Of counsel for Guidant Corporation, et al. was Kara F. Stoll.

Appealed from: United States District Court for the District of Delaware

Chief Judge Sue L. Robinson United States Court of Appeals for the Federal Circuit 05-1515 MEDTRONIC, INC., Plaintiff-Appellant, v. GUIDANT CORPORATION, GUIDANT SALES CORPORATION AND ELI LILLY & COMPANY, Defendants-Appellees, and MIROWSKI FAMILY VENTURES L.L.C., Defendant-Appellee.

__________________________ DECIDED: October 12, 2006 __________________________

Before MICHEL, Chief Judge, SCHALL, and DYK, Circuit Judges.

Opinion for the court filed by Circuit Judge SCHALL. Concurring-in-part and dissenting- in-part opinion filed by Circuit Judge DYK.

SCHALL, Circuit Judge.

This is a patent case. Medtronic, Inc. (“Medtronic”) is a manufacturer of medical

devices. It filed a declaratory judgment action in the United States District Court for the

District of Delaware against Guidant Corporation, Guidant Sales Corporation, Eli Lilly & Company (“Eli Lilly”), and Mirowski Family Ventures L.L.C. In the action, Medtronic

alleged that claims 15-26 of U.S. Reissue Patent No. 38,119 (“the RE’119 patent”), a re-

issue of U.S. Patent No. 4,928,688 (“the ’688 patent”), are invalid by reason of violation

of the rule against recapturing surrendered subject matter. The RE’119 patent claims a

method and a pacemaker apparatus. Both relate to a “procedure for pacing of the heart

in a particular way so as to improve its contraction pattern, and thereby augment the

movement of blood through the heart.” RE’119 patent, col. 3, ll. 33-35. Mirowski Family

Ventures L.L.C. and Eli Lilly are, respectively, the assignee and exclusive licensee of

the patent. Guidant Corporation is a medical device manufacturer that was formed in

1994 when Eli Lilly divested certain assets, while Guidant Sales Corporation is a wholly

owned subsidiary of Guidant Corporation. For ease of reference, we refer to the four

defendants as “Guidant.”

Medtronic now appeals from the final judgment of the district court, following a

bench trial, that the RE’119 patent is not invalid. See Medtronic, Inc. v. Guidant Corp., 378 F. Supp. 2d 503 (D. Del. 2005). We affirm.

BACKGROUND I.

A.

The heart is made up of four chambers: two atria and two ventricles. Electrical

stimulations (depolarizations) within the chambers cause contractions within the heart

that result in pumping. The electrical activity arises in the right atrium and is eventually

transmitted to the ventricles. The period of time from depolarization of the atria to

depolarization of the ventricles is called the “A-V delay period.”

05-1515 2 Dr. Morton Mower is the inventor named on the RE’119 patent. His invention

involves a method and apparatus for treating ventricular asynchrony, a condition in

which a person has a defect in his or her heart ventricles. The defect causes the

ventricles to contract at different times. This results in the loss of effectiveness in the

pumping of blood. The method of the RE’119 patent works through a pacemaker

device invented by Dr. Mower which either conditionally or unconditionally paces the

two ventricles of the heart to cause simultaneous ventricular contractions. The

“conditional embodiment” of the invention requires sensing a depolarization in a first

ventricle, then waiting for a predetermined period of time to sense a depolarization in

the second ventricle. If no depolarization is sensed in the second ventricle, the device

stimulates, or “paces” the second ventricle with an electrical pulse. This embodiment of

the invention is called “conditional” because the delivery of pacing pulses depends on

the analysis of the cardiac signals. In the “unconditional embodiment,” depolarization is

sensed in either ventricle and, as soon as depolarization in one ventricle is sensed, both

ventricles are immediately paced. In the “unconditional embodiment,” one ventricle will

be paced twice, once naturally and once by the device.

In the invention’s conditional embodiment, there are two apparatuses to sense

electrical activity (“sensing electrodes”). There is one sensing electrode in each

ventricle. In addition, there is at least one pacing electrode to pace the second

ventricle. In the unconditional embodiment, there may be only one sensing electrode,

as once a depolarization is sensed in one ventricle, the other ventricle is immediately

paced. However, there are always two pacing electrodes, so that both ventricles may

be paced at the same time.

05-1515 3 B.

In the late 1980s, Dr. Mower asked Ron Cohn to prepare a patent application for

his invention. On October 30, 1987, Cardiac Pacemakers, Inc. (now a wholly owned

subsidiary of Guidant Corporation), where Dr. Mower was employed, forwarded Mr.

Cohn’s draft application to attorney Thomas Nikolai to prepare a final application. On

December 3, 1987, Mr. Nikolai asked Dr. Mower to review the draft application,

explaining that he had added the concept of a “window of coincidence”—a delay

between sensing and pacing.

On August 23, 1988, Mr. Cohn, pursuant to instructions from Dr. Mower,

forwarded Dr. Mower’s comments to Mr. Nikolai, advising him that the essence of Dr.

Mower’s invention was “a bi-ventricular pacer [that] continually senses the activity of

both the left and right ventricles, and when activity is sensed in either ventricle the

device immediately electrically paces the other or both ventricles.” With respect to Mr.

Nikolai’s concern about a “window of coincidence,” Mr. Cohn stated that to have a delay

between sensing and pacing would undermine the purpose of the invention, which he

said was to cause a simultaneous contraction of the ventricles. On August 31, 1988,

Mr. Nikolai responded to Mr. Cohn’s letter with a letter to Dr. Mower, stating that he was

“puzzled” about how the invention could sense the depolarization of one ventricle and

then decide whether to pace the other ventricle without a delay period.

On September 9, 1988, Dr. Mower explained to Mr. Nikolai that while the

mechanism would in some cases stimulate a ventricle that was in fact contracting

normally, that was not a problem because “the artificial stimulus will fall harmlessly into

05-1515 4 the intrinsic depolarization.” Mr. Nikolai then amended the specification to include a

description of the unconditional embodiment.

C.

On January 23, 1989, U.S. Patent Application No. 07/299,895 (“the ’895

application”) was filed with the Patent and Trademark Office for Dr. Mower’s invention.

As filed, the ’895 application had twenty-two claims, including six independent claims

(claims 1, 7, 15-17, and 19). Pertinent to this case, claims 1, 7, 15, and 16 of the ’895

application stated:

1. A method for improving the hemodynamic efficiency of a sick heart comprising the steps of: (a) detecting respective cardiac signals originating in the left and right ventricles of the heart; (b) analyzing said cardiac signals and the absence thereof in an electronic control circuit; (c) providing electrical pulses from a stimulating circuit controlled by said control circuit for effecting substantially simultaneous contraction of both ventricles.

7. An atrial-coupled bi-ventricular pacemaker for implantation or external use comprising atria and ventricular sensing means for detecting cardiac signals, a control circuit connected to said sensing means to analyze the cardiac signals and provide a control signal, a stimulating circuit for effecting simultaneous contraction of both ventricles in response to the control signal of the control circuit after a pre-determined A-V delay period.

15. A method for effecting simultaneous contraction of both left and right ventricles of a heart for improving hemodynamic efficiency comprising the steps of: separately sensing cardiac signals from both left and right ventricles; and stimulating at least one ventricle substantially simultaneously with the contraction of at least one other ventricle.

16. A method of effecting simultaneous contraction of both left and right ventricles of a heart for improving hemodynamic efficiency comprising the steps of:

05-1515 5 sensing the cardiac signals of the atria and separately sensing the cardiac signals of both the left and right ventricles; and stimulating at least one ventricle simultaneously with the contraction of at least one other ventricle after a predetermined A-V period.

The specification included the following language directed towards the unconditional

embodiment:

It is also contemplated that when a ventricular depolarization signal is sensed in one or the other of the ventricles, that a stimulating pulse may also be immediately delivered, on an unconditional basis, to both ventricles, via the implanted leads 13 and 15, thus resulting in a coordinated contraction of both ventricles.

On June 9, 1989, the examiner issued a first office action, allowing claims 15 and

16 but rejecting the remaining twenty claims. Independent claims 1 and 7 and

dependent claims 4-6 and 12-14 were rejected as anticipated by U.S. Patent No.

4,378,020 (“Nappholz”). The examiner asserted that Nappholz showed “all of the

structure of the above claims.” At the same time, the examiner rejected dependent

claims 2, 3, 8, and 9 as obvious in view of Nappholz and U.S. Patent No. 4,774,950

(“Cohen”). The examiner asserted that Cohen showed “a means to sense a cardiac

signal from the left or right ventricles. It is deemed to have been obvious to use Cohen

with the pacemaker in Nappholz et al in order to more efficiently and effectively pace

and sense the heart.” The examiner explained, however, that “[t]he prior art does not

show means to sense and stimulate both ventricles in a selective or alternate manner.”

The examiner suggested that dependent claims 10 and 11 and independent claims 17

and 19, as well as dependent claims 18 and 20-22, would be allowed if their form was

corrected.

05-1515 6 Mr. Nikolai responded on June 16, 1989, by canceling claim 6, by adding several

claims, and by amending certain claims. Mr. Nikolai added independent claim 23 and

dependent claims 24-27, all directed to the pacemaker apparatus. At the same time, he

amended limitation (c) of claim 1 to read as follows: “providing electrical pulses from a

stimulating circuit controlled by said control circuit to one, the other or both ventricles as

required for effecting substantially simultaneous contraction of both ventricles.”

(Amendment underlined). At the same time, Mr. Nikolai amended the first clause of

claim 7 to read as follows: “An atrial-coupled bi-ventricular pacemaker for implantation

or external use comprising [atria] atrial and ventricular sensing means for detecting

cardiac signals originating in the atrium and both ventricles. . . .” (Amendment

underlined, removal bracketed). Mr. Nikolai distinguished the prior art from independent

claims 1 and 7 and dependent claims 12-14 by arguing:

[I]t is clear that the method being claimed involves detecting the respective cardiac signals originating in the left and the right ventricles of the heart. After analyzing those cardiac signals (or the absence thereof) in an electronic control circuit, electrical pulses are provided from a stimulating circuit to one, the other or both ventricles for effecting substantially simultaneous contraction of both ventricles. Clearly, Nappholz does not teach this method. The Nappholz patent describes a . . . pacemaker having a single atrial electrode and a single ventricular electrode . . . . Thus, the device of that patent is incapable of picking up ventricular depolarization signals from both ventricles.

(Emphasis in original).1 Mr. Nikolai further argued that claims 7 and 12-14 of the ’895

application were distinguishable over Nappholz because, unlike Nappholz, they called

for “sensing cardiac signals originating in the atrium and in both ventricles and then

stimulating both ventricles in a fashion such that simultaneous contraction of the 1 As far as dependent claims 4 and 5 were concerned, Mr. Nikolai stated that claims 4 and 5 further defined and restricted the method of claim 1 and that since claim 1 was allowable over the prior art, they were, too.

05-1515 7 ventricles occur[s] after a predetermined A-V delay period.” Mr. Nikolai argued that

dependent claims 2, 3, 8, and 9 of the ’895 application were not obvious in light of

Nappholz and Cohen because Nappholz disclosed a pacemaker that sensed and

selectively paced an atrium and sensed and selectively paced a ventricle, while Cohen

had electrodes in the ventricles that paced but did not sense. He urged that the two

references did not suggest the idea of placing sensing electrodes in both the left and right ventricles and providing a control circuit capable of detecting the depolarization signals from both the left and right ventricles and to then provide control signals to a stimulating circuit that is used to stimulate one, the other or both ventricles whereby substantially simultaneous contraction of both ventricles and improved hemodynamic efficiency results.

(Emphasis in original).

The examiner responded on September 6, 1989, allowing dependent claims 4

and 15-22, but rejecting all other pending claims. Claims 1-3 and 5 were rejected as

obvious in view of U.S. Patent No. 4,088,140 (“Rockland”) on the ground that the

method of claims 1-3 and 5 would be “within the scope of the skilled artisan when

utilizing the Rockland . . . invention.” Claims 7-9 and 12-14 were rejected as anticipated

in view of Rockland on the ground that “Rockland . . . shows all of the basic structure of

the above claims.” Claims 10, 23, and 25-27 were rejected as being obvious in view of

Rockland and U.S. Patent No. 3,937,226 (“Funke”) because it would be “an obvious

engineering design choice . . . to connect the ventricular electrodes in series, as shown

by Funke.” Finally, claims 11 and 24 were rejected as being obvious in view of

Rockland and Funke and further in view of an additional patent (“McCorkle”) because

“[i]t would have been obvious to one of ordinary skill in the art to use McCorkle with

05-1515 8 Rockland et al and Funke in order to more efficiently and accurately pace/sense

ventricular depolarizations.”

Mr. Nikolai responded by amending certain claims and canceling claims 4, 7-14,

and 25-27. He amended claim 1 to add the following to limitation (c) of the claim:

said step of analyzing including providing a control signal from said control circuit to said stimulating circuit for producing an electrical stimulating pulse to one or both ventricles in response to the absence of a detected cardiac signal from one or both ventricles within a time interval which is a small fraction of the pulse width of a detected cardiac signal.

Mr. Nikolai contended that, after this amendment, claim 1 and claims 2, 3, and 5, which

depended directly or indirectly from claim 1, were allowable. Mr. Nikolai argued that

claim 23 was not obvious in light of Rockland and Funke because Rockland failed “to

disclose a pacer apparatus having circuitry for analyzing cardiac signals originating in

the right and left ventricles for selectively providing stimulating or pacing pulses only to

the right ventricle if a normal cardiac signal is missing there or to the left ventricle if the

left ventricle is not producing normal heart activity in the left ventricle.” Because claim

24 depended from claim 23, Mr. Nikolai asserted that it too was not obvious.

On December 5, 1989, the examiner and Mr. Nikolai conducted a telephone

interview. After the interview, the examiner made an examiner’s amendment for “minor

wording changes” to put claims 15, 16, and other claims “in condition for allowance.”

The Notice of Allowability issued on December 11, 1989. After the amendment, claims

15 and 16 of the ’895 application read as follows:

15. A method for effecting simultaneous contraction of both left and right ventricles of a heart for improving hemodynamic efficiency comprising the steps of: separately sensing for the presence of cardiac depolarization signals from both left and right ventricles;

05-1515 9 determining whether said cardiac depolarization signals are simultaneously present in both the left and right ventricles; and stimulating at least one ventricle substantially simultaneously with the contraction of at least one other ventricle in the event that said cardiac depolarization signals are determined not to be simultaneously present in both ventricles.

16. A method of effecting simultaneous contraction of both left and right ventricles of a heart for improving hemodynamic efficiency comprising the steps of: sensing the cardiac signals of the atria and separately sensing the cardiac depolarization signals of both the left and right ventricles; determining whether said cardiac depolarization signals are simultaneously present in both the left and right ventricles; stimulating at least one ventricle simultaneously with the contraction of at least one other ventricle after a predetermined A-V period in the event that said cardiac depolarization signals are determined not to be simultaneously present in both ventricles.

(Examiner’s amendment emphasized). As can be seen, whereas before the examiner’s

amendment claims 15 and 16 claimed Dr. Mower’s unconditional embodiment, after the

amendment they claimed only the conditional embodiment.

On May 29, 1990, the ’688 patent issued to Dr. Mower. Claims 1-3, 5, and 15-24

of the ’895 application issued as, respectively, claims 1-14 in the ’688 patent.

D.

On May 29, 1992, pursuant to 35 U.S.C. § 251 , Mr. Cohn, on behalf of Dr.

Mower, sought reissue of the ’688 patent with existing claims 1-14 and new claims 15-

24. Claims 15-24 of the application were directed to the unconditional embodiment. Dr.

Mower’s reissue declaration stated that he had “claimed less than [he] had a right to

claim in the patent” as the claims inadvertently did not include the unconditional

05-1515 10 embodiment.2 He suggested that the embodiment was disclosed in the specification,

that it might be implicitly covered by the claims, but that it was not explicitly claimed.

On April 8, 1993, the examiner rejected all claims in the reissue application. The

examiner rejected new claims 15-24 pursuant to 35 U.S.C. § 112 , first paragraph,

stating that the specification did not support the invention. He explained that in the

specification, “it is mentioned that both ventricles are immediately stimulated,” but in

claims 15-24, “it is claimed that one or both ventricles are immediately stimulated.”

(Underlining in original).

Mr. Cohn amended claims 15, 16, 19, and 20 to more explicitly claim the

unconditional embodiment and argued that the specification did describe the invention.

The examiner then allowed reissue claims 1-18 and 20-24, but rejected claim 19. The

examiner asserted that claim 19 was obvious in light of U.S. Patent No. 4,624,260

(“Baker”) and Rockland and obvious in light of Baker and Funke. Mr. Cohn responded

by arguing that claim 19 was not obvious in light of the prior art because neither Baker

nor Rockland taught pacing in both ventricles followed by an A-V delay period. He also

added two claims, claims 25 and 26, to distinguish Baker, Rockland, and Funke.

The RE’119 patent issued on May 20, 2003. The RE’119 patent has 26 claims.

Claims 1-14 of the RE’119 patent are identical to claims 1-14 of the ’688 patent. Of the

remaining claims (which are new), claims 15, 19, 22, and 25 are independent.

2 Because of repeated objections from the Examiner, Dr. Mower eventually submitted five reissue declarations.

05-1515 11 II.

A.

On August 29, 2003, Medtronic filed a declaratory judgment action against

Guidant, alleging that claims 15-26 of the RE’119 patent are invalid because the

unconditional embodiment and the embodiment with only one sensing electrode were

improperly recaptured. The unconditional embodiment appears in claims 15-26. Claim

15 of the RE’119 patent is representative. It states:

15. A method for improving the hemodynamic efficiency of a heart comprising the steps of: detecting a cardiac depolarization signal originating from a first ventricle; immediately and unconditionally stimulating both ventricles for effecting a coordinated contraction of both ventricles when a cardiac depolarization signal originating from the first ventricle is detected. RE’119 patent, claim 15. The embodiment requiring only one sensing electrode

appears in at least claims 15, 16, 25, and 26 of the RE’119 patent.3 Representative

claim 15, for example, is broad enough to include a device with one sensing electrode

because it only requires “detecting a cardiac depolarization signal originating from a first

ventricle.”

Medtronic urged that both the unconditional embodiment and the embodiment

with only one sensing electrode were recaptured because they were claimed in the 3 The district court found that the RE’119 patent is “broad enough to include a device with one sensing electrode,” as claim 15 of the RE’119 patent claims a device with only one ventricular sensing electrode because “it requires only ‘detecting a cardiac depolarization signal originating from a first ventricle. . . .’” Medtronic, 378 F. Supp. 2d at 517-18 . Medtronic asserts that claims 15, 16, and 22-26 of the RE’119 patent claim the embodiment with only one sensing electrode. Guidant does not appear to dispute that claims 15, 16, 25, and 26 claim the embodiment with only one sensing electrode, but it asserts that claims 22-24 of the RE’119 patent require sensing from both ventricles. It is not necessary, for the reasons discussed below, for this court to decide whether claims 22-24 require sensing from both ventricles.

05-1515 12 original claims and amended during prosecution, or they were surrendered via

argument during prosecution. Specifically, Medtronic asserted that claims 1, 7, 15, and

16 of the ’895 application cover the unconditional embodiment, but were amended to

cover only the conditional embodiment. As far as the embodiment with one sensing

electrode was concerned, Medtronic argued that the embodiment, which it asserted

appears in claims 15-18 and 22-26 of the RE’119 patent, was surrendered during

prosecution.

In November 2004, the district court held a three-day bench trial. Medtronic

argued that there was no error during the prosecution of the ’895 application that would

justify reissuing the patent under 35 U.S.C. § 251 . Guidant responded that the error

was attorney error resulting from Mr. Nikolai’s failure to understand the technology.

In its decision rendered after trial, the district court ruled that the RE’119 patent

did not improperly recapture subject matter that was surrendered during prosecution.

Medtronic, 378 F. Supp. 2d 503 . It rejected Medtronic’s argument that Dr. Mower

surrendered the unconditional embodiment and any embodiment with only one sensing

electrode, agreeing with Guidant that the original claims of the ’895 application did not

include the unconditional embodiment and that Dr. Mower did not surrender a device

that senses depolarizations in only one ventricle. Id. at 515-19 .

The court first determined that the unconditional embodiment was not

surrendered by amendment. Id. at 515-16 . The court found that the claims of the ’895

application that originally included the unconditional embodiment were claim 15 of the

’895 application, which became claim 5 of the ’688 patent, and claim 16 of the ’895

application, which became claim 6 of the ’688 patent. Id. The court noted that, at the

05-1515 13 end of prosecution, the examiner narrowed the two claims to exclude immediate and

unconditional pacing. Id. at 516 . The court reasoned that neither claim 15 nor 16 of the

’895 application was rejected as anticipated over prior art and that the addition of the

conditional limitation to the claims, when they became claims 5 and 6 of the ’688 patent,

were wording changes, as characterized by the examiner, so the recapture rule did not

apply to the reissue claims of the RE’119 patent that include the unconditional

embodiment—claims 15-26 of the RE’119 patent. Id.

The court next found that the unconditional embodiment was not surrendered by

argument. Id. at 517 . The court determined first that the distinction over Nappholz

made by Mr. Nikolai during prosecution was “directed towards the fact that Nappholz

only discloses one electrode, not whether Nappholz immediately and unconditionally

paces both ventricles.” Id. Next, the court found Mr. Nikolai distinguished Cohen

because Cohen “did not have electrodes that could both sense and pace, and not

because of the way it paced the ventricles.” Id. Addressing the distinction that Mr.

Nikolai drew over Rockland, the court stated that “Rockland described a device that

paced a plurality of sites over a predetermined time period,” while “the unconditional

embodiment immediately paces the ventricles and, therefore, has no predetermined

time period.” Id.

The court also found that the embodiment with only one sensing electrode—

specifically, the embodiment represented by claim 15 of the RE’119 patent—was not

surrendered during prosecution by amendment. Id. The court determined that claim 15

of the RE’119 patent “claims a device with only one ventricular sensing electrode (as it

requires only ‘detecting a cardiac depolarization signal originating from a first ventricle’)

05-1515 14 and two pacing electrodes (as it paces both ventricles unconditionally).” Id. at 517-18 .

The claims of the ’895 application, which issued in the ’688 patent, however, did not

include an embodiment with only one sensing electrode: “[a]ll of the claims of the ’895

application refer to some means of sensing in both the right and left ventricles.” Id. at

517 (emphases in original). The court concluded that “[b]ecause the claims of the ’895

application did not include an embodiment without two sensing electrodes, the patentee

did not surrender subject matter [relating to just one sensing electrode] via an

amendment during prosecution.” Id. at 518 .

Finally, the district court determined that the embodiment with only one sensing

electrode, which is claimed in claim 15 of the RE’119 patent, was not surrendered by

argument. Id. The court first considered arguments made to distinguish the claimed

invention over Nappholz. Id. During prosecution of the ’895 application, Dr. Mower

distinguished Nappholz on the ground that it did not have two sensing electrodes and

two pacing electrodes. Id. The court noted that, in distinguishing Nappholz, Mr. Nikolai

had stated that “the Nappholz device was ‘incapable of picking up ventricular

depolarization signals from both ventricles and for ultimately providing stimulation to

both ventricles,’ which was characteristic of the invention of the ‘688 patent.” Id. The

district court reasoned that, “[a]ssuming that these statements are sufficient to surrender

subject matter during prosecution, the surrendered subject matter, i.e., a pacemaker

with one ventricular pacing electrode, does not appear in the reissue claims.” Id. The

court pointed out that the device of claim 15 of the RE’119 patent explicitly requires

pacing in both ventricles and that therefore the claim “does not recapture the subject

matter allegedly relinquished to distinguish Nappholz, as the Nappholz device only

05-1515 15 allowed for one pacing electrode.” Id. With respect to arguments made over Cohen,

the court explained that Cohen was distinguished because it only had electrodes that

paced and did not sense depolarizations. Id. “Such an embodiment,” the court stated,

“is not included in the reissue claims, which require at least one electrode that can both

sense and pace.” Id. Finally, the district court turned to the argument that was made

during prosecution to distinguish Rockland. The court noted that Mr. Nikolai had

distinguished Rockland from the invention claimed in the ’895 application on the ground

that it did not have analyzing circuitry and that it paced the heart over a predetermined

time period at a plurality of points upon sensing depolarization. Id. The court

determined that because the reissue claims require immediate and unconditional pacing

of only the ventricles upon depolarization, “they do not include the embodiment

disclosed in Rockland because they do not include a predetermined time period or

pacing at more than two points.” Id. Based upon its analysis, the district court ruled

that, by claiming an embodiment with only one sensing electrode, the RE’119 patent did

not recapture material that was surrendered by argument during prosecution of the ’895

application. Id.

After judgment was entered, Medtronic filed a timely notice of appeal. We have

jurisdiction pursuant to 28 U.S.C. § 1295 (a)(1).

DISCUSSION I.

Pursuant to 35 U.S.C. § 251 , a patentee may obtain reissue of a patent if the

patent is, through error “without any deceptive intention, deemed wholly or partly

inoperative or invalid, . . . by reason of the patentee claiming more or less than he had a

05-1515 16 right to claim in the patent . . . .” 35 U.S.C. § 251 ; see also 37 C.F.R. § 1.175 . “In

considering the ‘error’ requirement, we keep in mind that the reissue statute is ‘based

on fundamental principles of equity and fairness, and should be construed liberally.’”

Hester Indus., Inc. v. Stein, Inc., 142 F.3d 1472, 1479 (Fed. Cir. 1998) (citation omitted).

We have stated that “[a]n attorney’s failure to appreciate the full scope of the invention

is one of the most common sources of defects in patents,” and is generally sufficient to

justify reissuing a patent. In re Wilder, 736 F.2d 1516, 1519 (Fed. Cir. 1984); see also

Hester, 142 F.3d at 1479-80 ; In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997);

Mentor Corp. v. Coloplast, Inc., 998 F.2d 992, 995 (Fed. Cir. 1993); Scripps Clinic &

Res. Found. v. Genentech, Inc., 927 F.2d 1565 , 1575 (Fed. Cir. 1991). It is not

necessary that the error be unavoidable or that the error could not have been

discovered by the patentee through proper communication with the prosecuting

attorney. Wilder, 736 F.2d at 1519 .

Reissue proceedings, however, cannot be used to obtain subject matter that

could not have been included in the original patent. Under the “recapture” rule, the

deliberate surrender of a claim to certain subject matter during the original prosecution

of the application for a patent “made in an effort to overcome a prior art rejection” is not

such “error” as will allow the patentee to recapture that subject matter in a reissue.

Clement, 131 F.3d at 1468-69 . Thus, the recapture rule prevents a patentee from

regaining, through reissue, subject matter that was surrendered during prosecution of

the original patent in an effort to obtain allowance of the original claims. Pannu v. Storz

Inst., Inc., 258 F.3d 1366, 1371 (Fed. Cir. 2001); see also Hester, 142 F.3d at 1479 -80

05-1515 17 (“[A] surrender is not the type of correctable ‘error’ contemplated by the reissue

statute.”).

A surrender can occur by argument as well as by amendment. Hester, 142 F.3d

at 1480-84 (noting the statement in Clement that “‘[t]o determine whether an applicant

surrendered particular subject matter, we look to the prosecution history for arguments

and changes to the claims made in an effort to overcome a prior art rejection’” (quoting

Clement, 131 F.3d at 1469 ) (emphasis added in Hester, 142 F.3d at 1480 )). We stated

in Hester that, like prosecution history estoppel, “unmistakable assertions made to the

Patent Office in support of patentability” “can give rise to a surrender for purposes of the

recapture rule.” Id. at 1482 .

“We apply the recapture rule as a three-step process: (1) first, we determine

whether, and in what respect, the reissue claims are broader in scope than the original

patent claims; (2) next, we determine whether the broader aspects of the reissue claims

relate to subject matter surrendered in the original prosecution; and (3) finally, we

determine whether the reissue claims were materially narrowed in other respects, so

that the claims may not have been enlarged, and hence avoid the recapture rule.” N.

Am. Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1349 (Fed. Cir. 2005)

(citing Clement, 131 F.3d at 1471 ); see also Pannu, 258 F.3d at 1371 (citing Hester, 142 F.3d at 1482-83 ; Clement, 131 F.3d at 1470 ).

Determining whether the claims of a reissued patent violate 35 U.S.C. § 251 is a

question of law, which we review de novo. Pannu, 258 F.3d at 1370 . The legal

conclusion of whether an applicant has met the statutory requirements of 35 U.S.C.

05-1515 18 § 251 is based on underlying findings of fact, which we sustain unless they are clearly

erroneous. Clement, 131 F.3d at 1468 .

II.

A.

Medtronic contends first that claims 15 through 26 of the RE’119 patent are

invalid because they recapture the unconditional embodiment. Medtronic asserts that

this embodiment was surrendered both by amendment and by argument during

prosecution of the ’895 application.

1.

Medtronic argues that claims 1, 7, 15, and 16 of the ’895 application, as filed,

covered the unconditional embodiment and that, during prosecution, their scope was

limited to the conditional embodiment. It argues that claims 15 through 26 of the

RE’119 patent improperly recapture the unconditional embodiment. Guidant responds

that the recapture rule does not apply to claims 15-26 of the RE’119 patent because, as

filed, claims 1, 7, 15, and 16 of the ’895 application were directed to the conditional

embodiment. It urges that the district court correctly held that the unconditional

embodiment was not surrendered by amendment.

The first issue is whether the claims at issue, in this case claims 1, 7, 15, and 16

of the ’895 application,4 ever disclosed the unconditional embodiment. See N. Am.

Container, 415 F.3d at 1349 . If they did, the second issue is whether the unconditional

embodiment was surrendered during prosecution. See id. If it was, the final question is 4 As seen above, claims 1, 15, and 16 of the ’895 application issued as, respectively, claims 1, 5, and 6 in the ’688 patent. Claim 7 of the ’895 application was cancelled during prosecution.

05-1515 19 whether the RE’119 claims were materially narrowed in other respects so that the

claims may not have been enlarged and thus avoid the recapture rule. See id.

“Whether amendments made during reexamination enlarge the scope of a claim

is a matter of claim construction.” Hockerson-Halberstadt, Inc. v. Converse Inc., 183

F.3d 1369, 1373 (Fed. Cir. 1999). “‘A claim of a reissue application is broader in scope

than the original claims if it contains within its scope any conceivable apparatus or

process which would not have infringed the original patent. A reissue claim that is

broader in any respect is considered to be broader than the original claims even though

it may be narrower in other respects.’” Id. at 1374 (quoting Tillotson, Ltd. v. Walbro

Corp., 831 F.2d 1033 , 1037 n.2 (Fed. Cir. 1987)); see also Pannu, 258 F.3d at 1371

(stating that a reissue claim that does not include a limitation present in the original

claims is broader than the original claim).

We agree with the district court and Guidant that independent claims 1 and 7 of

the ’895 application as filed, and the claims that depended from them, claims 2-6 and 8-

14, did not disclose the unconditional embodiment. See Medtronic, 378 F. Supp. 2d at

516 n.22. As the district court recognized, these claims as filed required the processing

of signals, while in the unconditional embodiment, the device does not analyze or

process any signals because it immediately and unconditionally stimulates the

ventricles. Claim 1 of the ’895 application as filed required that the device “analyz[e]

said cardiac signals and the absence thereof,” while claim 7 of the application as filed

was limited to a device with a “control circuit connected to said sensing means to

analyze the cardiac signals and provide a control signal.” Claims 1 and 7 of the ’895

application never covered the unconditional embodiment. Because claims 1 and 7 of

05-1515 20 the ’895 application as filed did not include the unconditional embodiment, the recapture

rule does not apply with respect to those claims.

We agree with the district court and Medtronic that claims 15 and 16 of the ’895

application as filed did include the unconditional embodiment. Claims 15 and 16 of the

’895 application as filed disclosed a method for effecting simultaneous contraction of

both left and right ventricles. In claim 15, one step was “stimulating at least one

ventricle substantially simultaneously with the contraction of at least one other

ventricle.” Claim 15 clearly covered the unconditional embodiment because it

immediately paced. In claim 16 as filed, one step was “stimulating at least one ventricle

simultaneously with the contraction of at least one other ventricle after a predetermined

A-V period.” While there was a delay in claim 16, there was no analysis step. Both

claims described a device that paces at least one ventricle after the contraction of at

least one ventricle, so the claims as filed were directed to a device that immediately

paces the ventricles—i.e., the unconditional embodiment.

Because claims 15 and 16 did include the unconditional embodiment, we must

consider whether the unconditional embodiment was surrendered during prosecution.

We agree with the district court and Medtronic that after the examiner’s amendment—

characterized as making “minor wording changes”—claims 15 and 16 no longer covered

the unconditional embodiment. After the examiner’s amendment, claim 15 of the ’895

application as issued (claim 5 in the ’688 patent) had the additional limitations of

“determining whether said cardiac depolarization signals are simultaneously present in

both the left and right ventricles; and stimulating at least one ventricle substantially

simultaneously with the contraction of at least one other ventricle in the event that said

05-1515 21 cardiac depolarization signals are determined not to be simultaneously present in both

ventricles.” ’688 patent, claim 5 (examiner’s amendment emphasized). Claim 16 of the

’895 application as issued (claim 6 in the ’688 patent) had the additional limitations of

“determining whether said cardiac depolarization signals are simultaneously present in

both the left and right ventricles; stimulating at least one ventricle simultaneously with

the contraction of at least one other ventricle after a predetermined A-V period in the

event that said cardiac depolarization signals are determined not to be simultaneously

present in both ventricles.” Id., claim 6 (examiner’s amendment emphasized). With the

addition of the language “determining whether said cardiac depolarization signals are

simultaneously present in both the left and right ventricles,” claims 15 and 16 of the ’895

application as issued no longer covered immediately pacing both ventricles—i.e.,

unconditional pacing.

While claims 15 and 16 of the ’895 application did cover the unconditional

embodiment as filed, and while they were amended so that they no longer covered that

embodiment, that alone does not mean that the unconditional embodiment was

surrendered. This court has recognized that whether recapture applies “‘necessarily

depends upon the facts in each case and particularly on the reasons for the

cancellation.’” Mentor, 998 F.2d at 995 (quoting In re Willingham, 282 F.2d 353, 357

(C.C.P.A. 1960)). When we consider whether subject matter was “surrendered,” we

look at whether there was a deliberate withdrawal or amendment in order to secure the

patent, as this kind of deliberate action is not the inadvertence or mistake that reissue is

meant to remedy. See Clement, 131 F.3d at 1468-69 ; Mentor, 998 F.2d at 995 .

05-1515 22 In this case, there was no deliberate surrender of subject matter to obtain

allowance of the claims. As discussed above, an attorney’s failure to appreciate the full

scope of the invention is a common source of defects in patents and has been found to

be sufficient to justify reissuing a patent. See Hester, 142 F.3d at 1479-80 ; Clement, 131 F.3d at 1468 ; Mentor, 998 F.2d at 995 ; Scripps, 927 F.2d at 1575; Wilder, 736 F.2d

at 1519 . It is clear from the prosecution history that neither the examiner nor the

prosecuting attorney, Mr. Nikolai, considered the unconditional embodiment a part of

the invention. The fact that Mr. Nikolai thought the claims were directed to the

conditional embodiment alone is demonstrated by his correspondence with the inventor

and with the examiner. The fact that the examiner thought that the claim was to the

conditional embodiment alone is demonstrated by the examiner’s amendment he made

to add “minor wording changes.” This is the kind of inadvertence or mistake that the

reissue doctrine was meant to remedy.

Further, there is no evidence that the unconditional embodiment could not have

been included in the original patent. There is also no evidence that the unconditional

embodiment was deliberately surrendered in an effort to overcome a prior art rejection.

In fact, there was no prior art rejection, or any rejection at all. Thus, the examiner’s

amendment was not prompted by a rejection. We agree with the district court that

because claims 15 and 16 were not amended over prior art, and because the

amendments to the claims were made as clarifying amendments, there was no clear

admission that the unconditional embodiment was not patentable. For this reason, the

reissue rule does not apply with respect to these claims.

05-1515 23 Thus, we agree with the district court that claims 15 through 26 of the RE’119

patent are not invalid for recapturing the unconditional embodiment by amendment.

2.

Medtronic also argues that the unconditional embodiment in claims 15-26 of the

RE’119 patent was surrendered by argument. Guidant responds that Medtronic has not

shown a clear and unmistakable surrender as Hester requires.

We agree with the district court that Dr. Mower did not surrender the

unconditional embodiment through arguments made during prosecution. Mr. Nikolai

distinguished claims 1 and 7 of the ’895 application, and their dependent claims, which

were directed to the conditional embodiment, on the ground that Nappholz only

disclosed a single atrial electrode and a single ventricular electrode and thus was

unable to sense and pace both ventricles, which is what is claimed in claims 15 and 16

of the RE’119 patent. Thus, Mr. Nikolai did not distinguish Nappholz one the grounds

that Nappholz immediately and unconditionally paced both ventricles.

Mr. Nikolai also distinguished the rejected dependent claims 2, 3, 8, and 9 of the

‘895 application, which were directed to the conditional embodiment, from Cohen on the

ground that Cohen had electrodes in the ventricles that paced but did not sense. In the

unconditional embodiment in claims 15-26 of the RE’119 patent, however, there is at

lease one sensing electrode in a ventricle. Thus, Mr. Nikolai did not clearly and

unmistakably surrender the unconditional embodiment.

Medtronic also points to the arguments made by Mr. Nikolai with respect to

rejected claim 23 of the ’895 application in support of its argument that the unconditional

embodiment was surrendered by amendment. Mr. Nikolai distinguished Rockland

05-1515 24 because it could not selectively analyze and, instead, described a device that paced

over a predetermined time interval. The unconditional embodiment, on the other hand,

may immediately pace after a depolarization is sensed in one ventricle. Thus, Mr.

Nikolai did not clearly and unmistakably surrender the unconditional embodiment.

Thus, we agree with the district court that claims 15 through 26 of the RE’119

patent are not invalid for recapturing the unconditional embodiment by argument.

B.

Medtronic argues that claims 15, 16, and 22-26 of the RE’119 patent are invalid

because they recapture the embodiment with only one sensing electrode. According to

Medtronic, this embodiment was surrendered by amendment and argument during

prosecution of the ’895 application.

1.

Medtronic asserts that claim 7 of the ’895 application as filed covered sensing in

a single ventricle as well as sensing in both ventricles, and was amended to surrender

sensing in only one ventricle. According to Medtronic, claim 7 covered sensing in a

single ventricle because the term “ventricular sensing means” encompassed sensing in

either one ventricle or in both ventricles. Second, it asserts that claims 15, 16, and 22-

26 of the RE’119 patent improperly recapture the embodiment with only one sensing

electrode that was surrendered during prosecution. Guidant responds that the district

court correctly held that the embodiment with only one sensing electrode was not

surrendered by amendment because original claim 7 required sensing from both

ventricles and Medtronic’s arguments do not apply to reissue claims 22-24 because

they require sensing from both ventricles.

05-1515 25 The first issue we must address is whether claim 7 of the ’895 application ever

disclosed the “sensing of electrical activity in only one ventricle” embodiment. See N.

Am. Container, 415 F.3d at 1349 . If it did, the second issue is whether that subject

matter was surrendered during prosecution. Id. If it was, the final question is whether

reissue claims were materially narrowed in other respects so that the claims may not

have been enlarged to avoid the recapture rule. Id.

We agree with the district court that claim 7 in the ’895 application as filed did not

include an embodiment with only one sensing electrode. Medtronic is incorrect that

claim 7 of the ’895 application as filed covered sensing in a single ventricle as well as

sensing in both ventricles. The claim refers to a “bi-ventricular pacemaker,” indicating

that sensing is done in both ventricles. The claim uses the term “detecting cardiac

signals,” indicating that several sensing electrodes would be used. While one could

argue that the term “signals” as used means signals over time, instead of multiple

signals at the same time, later in the claim the singular term “signal” is used to describe

the control signal of the control circuit. If the term “signals” referred to one single source

of a signal over time, the claim would use “signals” again later when referring to the

control signal. The addition of the language “originating in the atrium and both

ventricles” does not narrow the scope of the claim, as it was always directed to sensing

in both ventricles. In fact, the addition of this language after “detecting cardiac signals”

demonstrates even more clearly that there are signals, and not a signal, which require

multiple sensing electrodes.

05-1515 26 Thus, we agree with the district court that claims 15, 16, and 22-26 of the RE’119

patent are not invalid for recapturing the embodiment with only one sensing electrode

by amendment.

2.

Medtronic also argues that the embodiment with only one sensing electrode in

the reissue claims was surrendered by argument. Guidant responds that the district

court correctly held that this embodiment was not surrendered by argument.

As discussed above, if the claims of a reissue patent violate the recapture rule,

the claims are invalid, see N. Am. Container, 415 F.3d at 1349 , and surrender can occur

by way of amendments or arguments, see Hester, 142 F.3d at 1480-81 . The district

court held that the embodiment with only one sensing electrode was not surrendered by

argument. Medtronic, 378 F. Supp. 2d at 518 . With respect to Nappholz, the court

recognized, that during prosecution of the ’895 application, Mr. Nikolai distinguished

Nappholz because Nappholz did not have two sensing electrodes and it also did not

have two pacing electrodes. Id. The court determined that, “[a]ssuming that these

statements are sufficient to surrender subject matter during prosecution,” the

surrendered subject matter—a pacemaker with one ventricular pacing electrode—did

not appear in the reissue claims because claim 15 of the RE’119 patent “explicitly

requires pacing in both ventricles.” Id. The court concluded that “[t]his does not

recapture the subject matter allegedly relinquished to distinguish Nappholz, as the

Nappholz device only allowed for one pacing electrode. Therefore, claim 15 is

materially narrowed and would have been patentable over Nappholz.” Id.

05-1515 27 We see no error in the district court’s ruling with respect to the arguments made

to distinguish Nappholz. As the court noted, Mr. Nikolai’s argument with respect to

Nappholz was based on the proposition that Dr. Mower’s invention was distinguishable

over, and narrower than, Nappholz because it required two sensing electrodes. As

indicated above, when a reissue claim, while broader in certain respects than the

original patent claim, is materially narrowed in other respects, the recapture rule does

not apply. See N. Am. Container, 415 F.3d at 1349 . The district court’s ruling with

respect to Mr. Nikolai’s arguments relating to Nappholz recognizes this rule.

Moreover, further support for the district court’s ruling lies in the fact that the

statements regarding Nappholz made during prosecution of the ’895 application were

not unmistakable assertions in support of patentability over the embodiment with a

single sensing electrode. Mr. Nikolai distinguished Nappholz from the conditional

embodiment on the ground that Nappholz had only a single atrial electrode and a single

ventricular electrode and thus was unable to sense and pace both ventricles.5 In the

unconditional embodiment claimed in the RE’119 patent, there may be only one sensing

electrode, as once a depolarization is sensed, both ventricles are immediately paced, 5 Mr. Nikolai distinguished Nappholz because it is clear that the method being claimed involves detecting the respective cardiac signals originating in the left and the right ventricles of the heart. After analyzing those cardiac signals (or the absence thereof) in an electronic control circuit, electrical pulses are provided from a stimulating circuit to one, the other or both ventricles for effecting substantially simultaneous contraction of both ventricles. Clearly, Nappholz does not teach this method. The Nappholz patent describes a . . . pacemaker having a single atrial electrode and a single ventricular electrode . . . . Thus, the device of that patent is incapable of picking up ventricular depolarization signals from both ventricles. (Emphasis in original).

05-1515 28 but there are two pacing electrodes in the ventricles, unlike Nappholz. We do not think

Mr. Nikolai’s statements about Nappholz’s single ventricular sensing electrode (which

were made in the context of distinguishing Nappholz from Dr. Mower’s conditional

embodiment) are unmistakable assertions in support of patentability distinguishing it

from the embodiment with only one sensing electrode. That is because the statements

were not made in the context of distinguishing Nappholz and the claimed invention

based on the number of sensing electrodes, but rather in the context of distinguishing

Nappholz from the conditional embodiment. In other words, we cannot say that the

statement was an unmistakable assertion in support of patentability that invalidates the

reissue patent claims covering the embodiment with only one sensing electrode.

As discussed above, Mr. Nikolai distinguished Cohen from his invention of the

ground that Cohen had electrodes in the ventricles that paced but did not sense. This

distinction is not relevant to the embodiment with only one sensing electrode, as Cohen

cannot sense. Finally, as far as Rockland is concerned, Mr. Nikolai distinguished

Rockland on the ground that it could not selectively analyze and, instead, described a

device that paced over a predetermined time interval. This distinction is also irrelevant

to the embodiment with only one sensing electrode, as that embodiment does not

require a predetermined time period.

Thus, we agree with the district court that claims 15, 16, and 22-26 of the RE’119

patent are not invalid for recapturing the embodiment with only one sensing electrode

because that embodiment was previously surrendered by argument.

05-1515 29 CONCLUSION In sum, we affirm the district court’s determination that claims 15-26 of the

RE’119 patent are not invalid. We do so because we agree with the district court that

neither the unconditional embodiment nor the embodiment with only one sensing

electrode, both of which were covered by those claims, was surrendered by amendment

or argument during prosecution of the ’895 application.

COSTS Each party shall bear its own costs.

AFFIRMED

05-1515 30 United States Court of Appeals for the Federal Circuit 05-1515 MEDTRONIC, INC., Plaintiff-Appellant, v. GUIDANT CORPORATION, GUIDANT SALES CORPORATION and ELI LILLY & COMPANY, Defendants-Appellees.

and MIROWSKI FAMILY VENTURES L.L.C., Defendant-Appellee.

DYK, Circuit Judge, concurring-in-part and dissenting-in-part.

I join the majority’s opinion insofar as it holds that claims 15, 16 and 22-26 of the

RE’119 patent did not impermissibly recapture the embodiment with only one sensing

electrode. I dissent insofar as the majority holds that the reissue patent’s claims 15-26,

which claim the unconditional embodiment, did not violate the recapture rule, because I

believe they impermissibly recapture the unconditional embodiment.

The recapture rule provides that an applicant may not regain, through reissue,

subject matter that was deliberately surrendered during prosecution of the original

patent in order to avoid a prior art rejection. In re Clement, 131 F.3d 1464, 1468 (Fed.

Cir. 1997). The recapture rule involves a three-step process: “(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original

patent claims; (2) next, we determine whether the broader aspects of the reissue claims

relate to subject matter surrendered in the original prosecution; and (3) finally, we

determine whether the reissue claims were materially narrowed in other respects, so

that the claims may not have been enlarged, and hence avoid the recapture rule.” N.

Am. Container, Inc., v. Plastipak Packaging, Inc., 415 F.3d 1335, 1349 (Fed. Cir. 2005).

Only a deliberate surrender of subject matter during prosecution will trigger application

of the recapture rule; an inadvertent surrender will not. Kim v. Conagra Foods, Inc., ---

F.3d ---, 2006 WL 2773237, at *7 (citing cases). The majority agrees that the claims

originally claimed the unconditional embodiment, that they were narrowed to exclude

the unconditional embodiment, that they were broadened during reissue to again cover

the unconditional embodiment, and that they were not materially narrowed during

reissue in other respects. But the majority further holds that there was no deliberate

surrender. I respectfully disagree.

In considering whether a deliberate surrender of subject matter has occurred, we

ask whether an objective observer viewing the prosecution history would conclude that

such a deliberate surrender happened in order to avoid an obstacle to patentability.

Kim, 2006 WL 2773237, at *7 . The surrender issue is a question of law. N. Am.

Container, 415 F.3d at 1349 . In my view, the timing and content of Mr. Nikolai’s

statements regarding claim 23, and of the examiner’s amendments to claims 15 and 16,

lead to the conclusion that Medtronic deliberately surrendered the unconditional

embodiment during prosecution of the original patent.

05-1515 2 It is clear, and the majority agrees, that claims 15 and 16, as originally drafted,

covered the unconditional embodiment of the invention as well as its conditional

embodiment. It is undisputed that, after the examiner’s amendment to claims 15 and

16, those claims no longer covered the unconditional embodiment. The examiner’s

statements made at the time of the amendment of claims 15 and 16—characterizing the

language changes as “minor wording changes”—on their face do not demonstrate a

concern with patentability. However, it is quite clear that the amendments were not, in

fact, minor wording changes, and the examiner stated that the amendments were

necessary in order to put claims 15 and 16 “in condition for allowance.” In light of the

prosecution history, the amendments to claims 15-16, in my view, were plainly directed

to patentability.

Claim 23 of the ‘895 application originally included both the conditional and

unconditional embodiments, as did the original language of claims 15 and 16. On

September 6, 1989, the examiner rejected claim 23 as obvious in light of the Rockland

and Funke prior art. Mr. Nikolai’s statements designed to overcome the rejection of

claim 23 were clearly directed towards patentability. In his September 26, 1989,

response to the examiner, Mr. Nikolai distinguished the prior art on the basis that

Rockland could not “analyz[e] cardiac signals” and “selectively . . . stimulat[e] or pac[e]”

one ventricle, in other words, that the prior art did not disclose the conditional

embodiment. Claim 23 was then amended to add language limiting it to the conditional

embodiment.1 Based on these representations as to the prior art and the amendment

1 The language of claim 23 is below. Language that was added in September is indicated by underscoring, and language that was deleted is in brackets: 05-1515 3 limiting the scope of claim 23 to the conditional embodiment, the claim eventually was

allowed as claim 13 of the ’688 patent (with minor additional language changes).

A few weeks after Mr. Nikolai’s statements concerning claim 23 and the

amendment to that claim, on December 5, 1989, the examiner similarly amended claims

15 and 16 to require “determining whether . . . signals . . . are simultaneously present,”

the very analysis function that Mr. Nikolai referred to in his claim 23 statement. The

language of claims 15 and 16 was also amended, as the language of claim 23 had been

amended, to make clear the conditional nature of the ventricle stimulation. Given this

sequence of events, I think it is clear that the examiner’s amendment to claims 15 and

16—which the majority agrees resulted in the elimination of the unconditional

embodiment and the limitation of the those claims to the conditional embodiment—was

made to avoid the same prior art that had caused claim 23’s original rejection. In other

words, an objective observer, viewing the prosecution history, would conclude that the

unconditional embodiment was deliberately surrendered to avoid a prior art rejection of An atrial-coupled, bi-ventricular pacemaker for implantation or external use comprising atrial and ventricular sensing means for detecting cardiac signals, said sensing means including first and second ventricular electrodes connected in series for sensing and stimulating the right and the left ventricles, respectively, and an atrial electrode adapted to be disposed in an atrial chamber for detecting cardiac signals of the atria, all of said electrodes being connected to separate ECG amplifier means for amplifying the sensed signals; a control circuit coupled to said ECG amplifier means for analyzing the cardiac signals picked up by said sensing means and providing a control signal; and a stimulating circuit [for effecting simultaneous contractions of both ventricles in response to said control signal following a predetermined A-V delay period] for producing an electrical stimulating pulse to the left ventricle in the absence of a detected cardiac signal from the left ventricle, or to the right ventricle in the absence of a detected cardiac signal from the right ventricle, or to both ventricles in the absence of detected cardiac signals from both ventricles to effect substantially simultaneous contraction of both ventricles after a predetermined A-V delay period. 05-1515 4 claim 23, and an analogous prior art problem in claims 15 and 16. Under these

circumstances, the recapture of the unconditional embodiment in the reissue patent was

improper.

05-1515 5