Appendix — Cox-Uphoff Corp. v. Mentor Corp.

S/ | 7 ee Cea

R Va j 523 BUTS 4 Dp”

IN THE MAR 14 1990

Supreme Court of the Unite States. sew.

OCTOBER TERM. 1989

COX-UPHOFF CORPORATION and

COX-UPHOFF INTERNATIONAL,

Petitioners,

Vv.

MENTOR CORPORATION;

LINDA RADOVAN WILLIAMSON,

as executrix of the Estate of CHEDOMIR RADOVAN:

HILTON BECKER, M.D.; and BEVERLEY ANNE BECKER;

Respondents.

APPENDIX TO

PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

JOHN J. CAVANAUGH

77 West Washington Street

Chicago, Illinois 60602

(312) 346-1200

Counsel of Record for

Petitioners

Of Counsel:

ARTHUR A. OLSON, JR.

DONALD A. PETERSON

RICHARD P. BEEM

NEUMAN, WILLIAMS,

ANDERSON & OLSON

77 West Washington Street

Chicago, Illinois 60602

(312) 346-1200

March 14, 1990

Pandick Midwest, Inc., Chicago @ (312) 733-6000

I

TABLE OF CONTENTS

APPENDIX TO PETITION FOR CERTIORARI

(Appendix Bound Separately)

Page

Opinion of the United States Court of Appeals For

The Federal Circuit Decided November 9, 1989 A-1

District Court Judgment on The Verdict Dated

ii se i teeestee tae aicncdenrncacenstbesinscesicnece: A-4,5

Order Of The United States District Court For the

Central District Of California Granting Defen-

dant’s Motion For Judgment Notwithstanding

The Verdict Dated January 27, 1989.00.00... A-6

District Court Findings of Fact And Conclusions

of Law Dated February 27, 1989.................cccee00 A-12

District Court Judgment Granting The Judgment

Notwithstanding The Verdict Dated February

ye RNR R Sn EIN AMES AE ns ee A-48

District Court Order Denying Defendant’s Motion

To Amend Findings of Fact And Conclusions Of

Law, And Granting Defendant’s Motion For A

New Trial Dated April 24, 1989... A-50

Federal Circuit Judgment Reversing The District

Court Granting of Judgment Notwithstanding

The Verdict Dated November 9, 1989................ A-52

Federal Circuit Order Denying The Petition For

Rehearing By The Panel Dated December 14,

PPI ic vciansiicansasiovidueauisiads seiuciesmelaiainactaniateaaictiialt debdiniwésntis A-53,54

Federal Circuit Order Denying The Suggestion For

Rehearing In Banc Dated January 8, 1990.......... A-56,57

Defendant’s Motion For Judgment Notwithstand-

ing The Verdict And Alternative Motion For New

PUREE CE TOT Dy Fie eceseseccencsinccceressrsereess A-58

Defendant’s Motion To Amend The Findings of

Fact And Conclusions Of Law Dated March 17,

il

TABLE OF CONTENTS TO APPENDIX (Cont'd)

Page

28 U.S.C. § 2071—Rule-Making Power Generally. A-98

28 U.S.C. §2072—Rules of Procedure And Evi-

GENCE; POWET 00 PYCRCTIVG .......2.0.cccccrccsensonescacssesees A-99

Federal Rules Of Civil Procedure: Rule 50(b),(c)—

Motion For A Directed Verdict And For Judg-

ment Notwithstanding The Verdict..................... A-99

Federal Rules Of Civil Procedure: Rule 59(b)—

New Trials; Amendment of Judgments ............... A-100

A-|

Note: This opinion has not been prepared for publication in

a printed volume because it does not add significantly to the

body of law and is not of widespread legal interest. It is a

public record. It is not citable as precedent. The decision will

appear in tables published periodically.

United States Court of Apprals

for the Federal Circuit

89-1302, -1348, -1472

MENTOR CORPORATION,

LINDA RADOVAN WILLIAMSON,

as executrix of the Estate of CHEDOMIR RADOVAN;

HiL_TON Becker, M.D.; AND

BEVERLEY ANNE BECKER,

Plaintiffs-Appellants,

v.

Cox-UPHOFF CORPORATION AND

Cox-UPHOFF INTERNATIONAL,

Defendants/Cross-Appellants.

DECIDED: November 9, 1989

Before RICH, MAYER, and MICHEL, Circuit Judges.

PER CURIAM.

DECISION

The judgment notwithstanding the verdict in favor of

Cox-Uphoff entered by the United States District Court for

the Central District of California, No. CV 87-561 1-JWC(Tx)

(Jan. 30, 1989), is reversed, and the case is remanded with

A-2

instructions that the district court enter judgment on the jury

verdict in its entirety and issue a permanent injunction

pursuant to it. The findings of fact and conclusions of law

supporting the judgment NOV, as well as the conditional

order of a new trial, are vacated. Cox-Uphoff’s cross-appeal

from the district court’s order denying its motion to amend

findings of fact and conclusions of law is dismissed, and Cox-

Uphoff will pay Mentor’s attorney fees incurred in responding

to the cross-appeai. Mentor will have its costs.

OPINION

“The district court focused on evidence in support of

{[Cox-Uphoffs] contentions, rather than on evidence in sup-

port of the jury’s findings. That approach constitutes revers-

ible legal error, particularly where, as here, it involves a

virtual disregard of substantial evidence on which the jury

could reasonably have reached a contrary determination.”

Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d

1565, 1572 (Fed. Cir. 1986). We agree with Mentor that

substantial evidence exists in the record to support the jury’s

findings; that is all Mentor need show to convince us that the

trial judge erred in granting Cox-Uphoff JNOV. /d. at 1571.

Not only did the district court disregard the findings of

the jury and the supporting record evidence, but it also

supplied a defense that Cox-Uphoff chose not to pursue and

that accordingly was not tried: the invalidity of the Becker

patent under section 102(b). The failure of Cox-Uphoffs

counsel to acknowledge. indeed its reliance on, the district

court’s error is disingenuous.

As for the cross-appeal. this court twice before has ad-

dressed the timeliness of Cox-Uphoffs post-judgment

motion. See Orders dated April 3. 1989, and May 23, 1989.

In the April 3 order we clearly stated that the motion, filed

March 17, 1989, was untimely because not filed within ten

days of entry of the final judgment on February 28, 1989.

A-3

See Fed. R. Civ. Pro. 59. Therefore. we dismiss Cox-Uphoff's

frivolous cross-appeal and award attorney fees in favor of

Mentor.

The district court’s conditional grant to Cox-Uphoff of

a new trial in response to this untimely motion 1s of no effect.

The ten day time period provided in Rule 59 is mandatory

and jurisdictional and cannot be extended in the discretion

of the district court. See Fiester v. Turner, 783 F.2d 1474,

1476 (9th Cir. 1986); Scott v. Younger, 739 F.2d 1464, 1467

(9th Cir. 1984).

A-4

UNITED STATES DistTrRiICT COURT

CENTRAL DISTRICT OF CALIFORNIA

MENTOR CorPoRATION, etal, |

eee ENTERED

Plaintif. OCT. 4, 1988 |.

P | CV87-5611-JWC for ER

aoe CORPORATION, JUDGMENT ON THE

VERDICT

Defendant. J} (For Plaintiff)

This cause having been tried by the Court and a Jury,

before the Honorable JESSE W. CURTIS, Judge presiding,

and the issues having been duly tried and the Jury having

duly rendered it’s verdict; now, therefore, pursuant to the

verdict,

IT IS ORDERED, ADJUDGED AND DECREED that

the plaintiffis) MENTOR CORPORATION, et al., have and

recover of and from the defendant(s) COX-UPHOFF COR-

PORATION, et a/., the sum of $486,000.00 as to the Becker

Patent, together with costs, taxed in the sum of

Clerk, U.S. District Court

Dated: October 3, 1988

By SHIRLEY C. FRACT

Deputy Clerk

CV 49 (3/87) JUDGMENT ON THE VERDICT

(For Plaintiff)

A-5

UNITED STATES District COURT

CENTRAL DISTRICT OF CALIFORNIA

MENTOR CORPORATION, etal, |

one ENTERED

Plaintiff, OCT. 4, 1988

o | CV87-5611-JWC for ER

pat CORPORATION, JUDGMENT ON THE

” VERDICT

Defendant. | (For Plaintiff)

This cause having been tried by the Court and a Jury,

before the Honorable JESSE W. CURTIS, Judge presiding,

and the issues having been duly tried and the Jury having

duly rendered it’s verdict; now, therefore, pursuant to the

verdict,

IT IS ORDERED, ADJUDGED AND DECREED that

the plaintiff(s) MENTOR CORPORATION, et al., have and

recover of and from the defendant(s) COX-UPHOFF COR-

PORATION, e¢ al., the sum of $204,000.00 as to the Radovan

Patent, together with costs, taxed in the sum of

Clerk, U.S. District Court

Dated: October 3, 1988

By SHIRLEY C. FRACT

Deputy Clerk

CV 49 (3/87) JUDGMENT ON THE VERDICT

(For Plaintiff)

A-6

UNITED STATES DistRICT COURT

CENTRAL DisTRICT OF CALIFORNIA

MENTOR CORPORATION, ef al., )

Plaintiff, NO. CV 87-5611-JWC (Tx)

y MEMORANDUM AND

| ORDER GRANTING

DEFENDANTS’ MOTION

FOR JUDGMENT N.0.V.

Cox-UPHOFF CORPORATION,

et al.,

Defendants.

This court has before it defendants’ motion for judgment

n.O.V. in this patent case in which the jury rendered a verdict

in favor of the plaintiffs, holding plaintiffs’ patents valid

and infringed by the defendants, and awarding substantial

damages.

Plaintiffs’ claims are based upon two patents. The earliest

is the Radovan patent No. 4,217,889, filed August 19, 1980,

entitled “Flap Development Device and Method of Progres-

sively Increasing Skin Area.” The second patent filed Febru-

ary 17, 1987, will be known as the Becker patent after its

inventor Hilton Becker. This patent is No. 4,643,733 and is

entitled “Permanent Reconstruction Implant and Method of

Performing Human Tissue Expansion.”

The basic tissue expander was discussed in an article in

“Plastic and Reconstructive Surgery” for February 1959,

which defines the tissue expander as a balloon that is flexible

in all directions when expanded by a tube passing through

the skin. This publication discloses the production of skin

expansion by the gradual inflation of a subcutaneous balloon

which was well known before the Radovan patent was issued

and, therefore, constitutes prior art. The one problem en-

countered in the use of this balloon-type tissue expander was

that it exerted localized pressure unevenly on the portion of

A-7

the body underlying the tissue expander. The Radovan patent

No. 889 claims to overcome this problem by a nonextensible

base along with a slack cover as illustrated in Figure 2 of the

Radovan patent drawings.

The patent describes a tissue expander having a base

that is substantially nonextensible, either inflexible or stiffly

flexible, thereby causing its area shape to be retained. The

stiffness of the base prevents excessive localized forces from

being exerted beneath the base or against underlying muscle.

Plaintiffs accuse the defendants of infringing claims

23-27, 29 and 30-31 of the Radovan patent No. 889, which

reads as follows:

Claim 23. A device to progressively increase skin

area over a prolonged period of time after surgical

implantation, comprising: a highly expandable skin

stretching chamber joined in flow communication

with a substantially less expandable puncture cham-

ber; said skin stretching chamber having a shape

retaining base that is substantially stiffer than a

flexible cover of the skin stretching chamber for

controlling the shape of such skin stretching chamber

during progressive enlargement; and the skin stretch-

ing chamber is collapsible to a volume substantially

less than one half of its inflatable volume for inser-

tion under a section of skin, whereby the skin stret-

ching chamber can be progressively enlarged by

periodic hypodermic injections through the skin into

the puncture chamber.

The other claims allege to have been infringed are all depen-

dent claims; consequently, Claim 23 is controlling.

The defendants manufacture a versafil tissue expander

line which consists of a balloon flexible in all directions when

expanded by a tube passing through the skin, both the design

and performance of which come within the teachings of prior

art, except the plaintiffs’ claim that the device has a shape

A-8

retaining base that is substantially stiffer than the flexible

cover for controlling the shape of the skin stretching chamber.

The defendants manufacture and sell versafil tissue expanders

that have a “backing” and unbacked expanders, but only the

back expanders are alleged to infringe Claim 23.

The precise issue, therefore, is does the versafil expander

have a shape retaining base that is substantially stiffer than

a flexible cover of the skin stretching chamber. Witness

Paulson testified that the backed versafil tissue expanders

consists of an injection port (a “less expanable puncture

chamber”), an all silk silicone envelope (a “skin stretching

chamber”) on to which a piece of silicone sheeting is bonded.

This sheeting has approximately the same hardness or duro-

meter reading as the envelope. Neither the sheeting nor the

envelope would be considered to be either rigid or stiff. The

shape of either the inflated or uninflated versafil expanders

are not determined by the sheeting bonded to one side of the

envelope, but by the shape of the mandrel on which the

envelope is cast. Hence, the versafil expanders do not have

a “shape retaining base that is substantially stiffer than the

flexible cover.”

In clinical use a versafil expander is inflated with sheeting

by “periodic hypodermic injections through the skin into the

puncture chamber.” Inflated expanders illustrated in Figures

4-13 in the Radavon patent all have perfectly flat bases, and

inflated versafil expanders, on the other hand, have both

the envelope and the sheeting extended. On the versafil

expanders the sheeting bonded to one side of the envelope is

there for the purpose of hiding cosmetic flaws in the envelope

and to make the tissue expander a little easier to insert into

the surgical pocket. It 1s also apparent to both those who

use and to those who design tissue expanders that a tissue

expender is still clinically functional without a nonextensible

or shape retaining base.

A physical examination of the two devices demonstrates

clearly the mgidity of the base of the Radavon device which

A-9

must be substantial in order to distribute the pressure evenly

over the base in order to effect the result that Radavon

claims. Whereas, the base of a versafil expander base is not

substantially stiffer than the flexible cover of the stretching

chamber and does not produce the result that the Radavon

patent claims.

I hold, therefore, that although the Radavon patent is

valid, given the presumption of validity and the insufficiency

of the evidence in the record to overcome such presumption,

the versafil device does not infringe Claims 23-27, 29-31 of

the Radavon patent 889.

BECKER PATENT

The plaintiffs also complain that the defendants have

infringed Claims 1, 2. 3, 4, 7 and 8 of the Becker patent.

Defendants answer that the patent in its entirety is invalid

as it does not present a patentable combination under 35

U.S.C. §103.

In December 1982, Dr. Becker presented a publication

entitled “Breast Reconstruction Using an Inflatable Breast

Implant With Detachable Reservoir,” which article was re-

vised in June 1983, shortly after his application for patent

was filed. In this publication he evaluates his discovery as

follows:

-

. the standard Heyer-Schulte type inflatable

breast implant has been modified to enable a reser-

voir to be attached and detached at a side filling

valve. The breast implant, therefore, functions ini-

tially as a tissue expander and then remains in

position as a permanent once the reservoir 1s

removed.”

Page 678 of Exh. 223.

In this publication Dr. Becker admits Claim | shows a

combination of the “standard Heyer-Schulte type implant”

A-10

which is prior art with a means of injecting the saline solution

into the implant by way of “a reservoir” of a type shown.

This reservoir is shown in the Radavon Patent 889 and is

therefore prior art.

As late as July 1987, Dr. Becker was still publishing how

he came about producing his Permanent Tissue Expander.

On page 519 of Exh. 206, he states as follows: “This concept

was initially achieved by attaching an injection dome to the

free end of the filling tube that is commonly used to inflate a

saline-inflatable implant.” This acknowledged substitution

is not a patentable combination under 35 U.S.C. § 103.

It appears that the patent examiner was of this opinion

when he initially reyected the Becker patent application claims

based upon the combination of the Heyer-Schulte implants

in combination with the Radavon 889 patent. During the

process, however, he came up with other reasons for rejecting

the patent application which was apparently amended to

satisfy these later objections. However, the examiner’s origi-

nal opinion that the application did not present a patentable

combination was lost in the shuffle and was not again

considered.

In his publication heretofore referred to, Dr. Becker

describes his advance in the art as follows:

Since first described the inflatable breast implant

has undergone several changes. Initially, the filling

tubes were fixed to the implant, the newer implants

now have selfsealing valves with detachable filling

tubes by attaching a reservoir to the filling tube a

regular inflatable breast implant is converted into a

tissue expander.

On page 678. he states: “Over a period of twenty months,

twenty-five cases representing twenty-three patients with a

total of thirty-four breasts have been operated on using this

implant.” Since the last revision of the article is stated to

have been made June 27, 1983, less than four months after

A-1]

the Becker application filing date, by his admission, the

alleged invention was in wse more than one year prior to the

application of the filing date and therefore is barred under

35 U.S.C. § 103.

I therefore hold that the Becker patent is invalid as it

consists of an unpatentable combination of prior art concepts,

and that the patented device was in use for more than one

year prior to the application for patent.

Judgment shall therefore be for the defendants and

against the plaintiffs. defendants to prepare and file proposed

findings of fact and conclusions of law.

DATED: January 27, 1989

Jesse W. CurTIS

JESSE W. CURTIS

United States District Judge

A-12

IN THE UNITED STATES DistRICT COURT

FOR THE CENTRAL DISTRICT OF CALIFORNIA

MENTOR CORPORATION. eral, }

Plaintiffs. No. CV 87-561 1-JWC (Tx)

- FINDINGS OF FACT AND

Cox-UPHOFF CORPORATION. CONCLUSIONS OF LAW

Defendant. |

€.

This cause having been tried by the Court and a Jury,

before the Honorable Jesse W. Curtis. Judge Presiding, during

the period September 13 through 22, 1988. The Jury rendered

a verdict in favor of the plaintiffs, holding plaintiffs’ patents

valid and infringed by the defendant, Cox-Uphoff Corpora-

tion,* and awarding substantial damages and Judgments were

entered on the verdicts.

Defendant moved for Judgment N.O.V. pursuant to

F. R. Civ. P. 50(b) to have the Judgments set aside in

accordance with the defendant's motion for a directed verdict.

The Court having heard the testimony and having examined

the proofs offered by the respective parties did. on January

30, 1989, grant defendant’s motion for Judgment N.O.V. and

ordered that Judgment be entered for the defendant and

against th= plaintiffs.

* Plaintiffs obtained a default judgment against Cox-Uphoff In-

ternational. one of the originally named defendants. However,

there is no evidence that Cox-Uphoff International continues to

exist or that if it does it has any rights or obligations pertaining to

the subject matter of this case. Consequently. these findings of fact

and judgment are intended to relate to the defendant Cox-Uphoff

Corporation only.

A-13

Accordingly, the Court makes its Findings of Fact anu

Conclusions of Law as follows:

FINDINGS OF FACT

It is true that:

I. General Background

Introduction

1. Plaintiff, Mentor Corporation (Mentor), is a Minne-

sota corporation, having its principal place of business in

Goleta, California.

2. Plaintiff, Linda Radovan Williamson is the executrix

of the Estate of Chedomir Radovan and is an individual with

her domicile and residence in the State of Illinois.

3. Plaintiff, Hilton Becker, M.D., is a resident of Palm

Beach, Florida.

4. Plaintiff, Beverly Anne Becker, is the wife of the

plaintiff, Dr. Hilton Becker, and is a resident of Palm Beach,

Florida.

5. Cox-Uphoff Corporation (Cox-Uphoff), is a Califor-

nia corporation, having its principal place of business in

Carpenteria, California.

6. Cox-Uphoff International, is a Nevada corporation,

having an address in Carpenteria, California.

7. This action was originally brought by the, plaintiff,

Mentor Corporation (Mentor), against the defendant Cox-

Uphoff International, for infringement of U.S. patents

4,217,889 (’889) and 4,643,733 (’733) on August 25, 1987.

The Complaint was first amended to add the Cox-Uphoff

Corporation, a California corporation, as a party defendant.

Cox-Uphoff International is not conducting any business of

any kind. Cox-Uphoff Corporation defended the lawsuit.

A-14

8. U.S. patent 4,217,889 was granted on August 19,

1980, in the names of Chedomir Radovan and Rudolf R.

Schulte as joint patentees. The ’889 patent was based on an

application bearing Serial No. 723,338 that was originally

filed in the U.S. Patent and Trademark Office on September

15, 1976. The original application was abandoned, in favor

of a continuation application bearing Serial No. 926,484 on

July 20, 1978.

9. U.S. patent 4,643,733 was granted on February 17,

1987, in the name of Hilton Becker as the sole patentee. The

‘733 patent was based on a patent application bearing Serial

No. 481,912 filed in the U.S. Patent and Trademark Office

on April 4, 1983.

10. The joint patentee Chedomir Radovan is deceased.

The second amendment to the Complaint added the executrix

of the Estate of the joint patentee Radovan as a party plaintiff,

representative of the ownership interest of the deceased

patentee of the ‘889 patent. The plaintiff-executrix is Linda

Radovan Williamson. The ownership interest of the other

joint patentee, Schulte. is owned by the plaintiff, Mentor, as

a result of succeeding to an assignment of Schulte’s entire

right, title and interest executed by Schulte to the Heyer-

Schulte Corporation.

11. The Becker ’733 patent is the subject of an exclusive

license from Becker to Mentor. The title to the ‘733 patent

is in the names of Dr. and Mrs. Hilton Becker as tenants in

the entirety. Dr. and Mrs. Becker have been added to the

Complaint as party plaintiffs upon agreement of Mentor and

Cox-Uphoff, and they were added as party plaintiffs by the

Court’s Pre-Trial Conference Order.

12. Dr. Chedomir Radovan exclusively licensed his

rights under his patent application Serial No. 723,338 on

December 14, 1976. to Heyer-Schulte Corporation. Mentor

has succeeded to Heyer-Schulte’s patent rights under the

Radovan license agreement.

A-15

13. While the Becker patent application, Serial

No. 481.912. was pending in the U.S. Patent and Trademark

Office, Dr. Becker entered into an exclusive license agreement

for the manufacture, use and sale of the subject matter of the

Becker patent application and any patent granted thereon on

June 3, 1985 (Ex. 274). ;

14. All the parties with an ownership interest in U.S.

patents 4,643,733 and/or 4,217,889, the two patents in suit,

have been joined as parties plaintiff. The party plaintiffs are

collectively referred to herein as “Mentor.”

15. The Schulte-Radovan patent 4,217,889 was granted

with 31 claims for a flap development device and method of

progressively increasing skin area. Of the 31 claims, Mentor

accused the defendants of infringing claims 23-27, 29, and

30-31 by the manufacture, use and sale of the “Versafil”

backed tissue expanders. The defendants’ unbacked tissue

expanders were not alleged to infringe the claims of the ‘889

patent.

16. The Becker patent 4,643,733 was granted on Febru-

ary 17, 1987, with 8 claims for a permanent reconstruction

implant and method of performing human tissue expansion.

Mentor has complained that the defendants have infringed

claims 1, 2, 3, 4. 7 and 8 of the eight claims of the Becker

patent by the manufacture, use and sale of their RDL-Xpand

reverse double lumen mammary prosthesis.

RADOVAN-SCHULTE PATENT 4,217,889

17. The Radovan-Schulte patent claims cover an expan-

sion device for implementation beneath the skin and sub-

cutaneous layer to cause the surface area of the skin which

overlays the device to be stretched for providing a flap to be

used in reconstructive surgery. The device comprises an

envelope with a substantially non-extendable base and a

cover. The cover is flexible and when the device is in an

unexpanded condition. the cover is slack. The device is

A-16

highly expandable in response to fluid conveyed between the

cover and the non-extensible base. The base causes the

device to expand away from the non-extensible base or

unidirectionally. (The base does not respond to the fluid by

expanding.) The device is expanded by the provision of a

reservoir coupled to a conduit and the inside of the thus

defined envelope. Fluid such as a saline solution is injected

into the envelope by a hypodermic needle piercing the reser-

voir and injecting the fluid therein and into the fill tube,

thereby into the envelope. When the device is implanted

below the skin, the needle pierces the reservoir through the

overlying skin. The conduit or fill tube of the expansion

device may be coupled to the envelope by means of a connec-

tor coupled to the envelope and the reservoir-fill tube combi-

nation to permit the reservoir and fill tube to be disconnected

as a unit from the expansion device at the connector. The

device includes a normally closed check valve to permit fluid

to be introduced into the envelope and maintained therein.

18. The Radovan-Schulte tissue expander as disclosed

in the ‘889 patent is restricted to a unidirectional, highly

expansible device due to its substantial non-extensible base,

as illustrated by the progressive expansion of the device in

Figures 4-7 of the ‘889 patent drawings wherein the device

is illustrated below the tissue to be expanded.

The History of Radovan-Schulte Patent Applications

19. The record reveals the applicants admitted before

the Patent and Trademark Office upon the filing of their

patent application the prior development of a tissue expander

in the form of a balloon that was flexible in all directions, as

noted in column 1. lines 43-56, of the ‘889 patent with

reference to the February. 1957. publication of Dr. Neumann

in “Plastic and Reconstructive Surgery.”

20. The 1957 publication of Dr. Neumann disclosed to

the art a basic tissue expander in the form of a balloon that

is flexible in all directions when expanded by a tube passing

A-17

through the skin. The Neumann publication discloses the

production of skin expansion by the gradual inflation of

a subcutaneous balloon which was well-known before the

Radovan et al patent application was filed in the Patent and

Trademark Office and therefore constitutes prior art. One

problem encountered in the use of this balloon type tissue

expander was that it exerted localized pressure unevenly on

the portion of the body underlying the tissue expander as the

Radovan et al ‘889 patent discusses in column 1], lines 50-

55.

21. The Radovan et al ‘889 patent claims to improve

over the Neumann balloon-type tissue expander for overcom-

ing the problem of exerting localized forces unevenly on

the portion of the body underlying the tissue expander by

providing a tissue expander having a non-extensible base

along with a slack cover as illustrated in Figure 2 of the

Radovan patent drawings.

22. The ’889 patent describes a tissue expander having

a base that 1s substantially non-extensible, either inflexible or

stiffly flexible, thereby causing its area shape to be retained.

The stiffness of the Radovan base prevents localized forces

from being exerted beneath the base or against underlying

muscle.

23. The highly expandable chamber results from the

patented embodiment by having “slack” in the cover to avoid

stretching the material. This is produced by the cover having

random wrinkles and to expand unidirectionally, as illus-

trated in Figures 2-7 of the ‘889 patent. The fully distended

condition of the patented tissue expander is illustrated in

Figure 7 of the patent drawings.

24. The arguments of Radovan’s patent counsel before

the Patent and Trademark Office, in distinguishing over the

prior art. stated that the claimed device has a substantially

non-extensible base and a flexible cover with a variable

external size. In addition. the base was characterized as

A-18

including a “substantially stiffer shape retaining base...”

These arguments resulted in the granting of the claims in the

‘889 patent.

Il. Validity of the 4,217,889 Patent

A. Scope and Content of Prior Art

25. The references before the Patent and Trademark

Office were as follows:

(a) The structure of the Neumann balloon-type

tissue expander was described in the February, 1957,

publication of “Plastic and Reconstructive Surgery,” Vol.

19. No. 1, pp. 124-130 in an article entitled “The Expan-

sion of an Area of Skin by Progressive Distention of a

Subcutaneous Balloon” as described hereinabove and

the problems experienced with the balioon-type tissue

expander.

(b) The patent examiner cited the following U.S.

patents showing various aspects of the Radovan et al

claimed structures:

3.538.917 11/1970 Selker

3.665.520 53/1972 Perras et al

3,744,063 7/1973 McWhorter et al

3.831.583 8/1974 Edmunds, Jr. et al

3.852.833 12/1974 Koneke et al

3.863.622 2/1975 Buuck

3.934.274 1/1976 Hartley, Jr.

None of the aforementioned patents discloses the

claimed tissue expander of the Radovan patent. namely,

an expander having a substantially non-extensible base for

Causing its area shape to be retained.

26. The following additional references. not before the

Patent Office. were relied on by the defendant at the trial to

further show the state of the art:

ee

A-19

(a) Sanders. et al—U.S. Patent 3.919.724

The patent discloses an injection port that works

like the port or reservoir in the Radovan-Schulte patent.

The patent includes a radio-opaque valve to increase or

decrease the amount of fluid within the flexible container

from a fluid source. The Sanders’ container 1s totally

collapsible during insertion. Embodiments are also dis-

closed with a similar valve for remote inflation.

(b) Boone—U:S. Patent 3,600,718

This patent discloses an injection port that allows

ain implanted shell to be inflated with saline. A sealing

gel is used through which the inflation stem 12 passes.

The shell is provided with reinforcing material 13 fixed

to the back of the shell.

(c) McGhan—U:S. Patent 3,852,832

This patent discloses a prosthesis which is fillable

with a gel or saline through a “Bronx cheer” type of filler

valve. The patent also discloses a prosthesis with a

relatively less flexible back area relative to the front.

(d) Perras—U.S. Patent 3,681,787

This patent discloses a breast prosthesis that permits

the injection of a gel after it is implanted. The breast

prosthesis includes a base surrounded with a solid non-

extensible rubber rim 22.

(e} Koken—Japanese Patent 2320/72 and Registra-

tion 956.809

This patent discloses an implantable device that can

be inflated after it is installed within the body. The

disclosed prosthesis includes a soft elastic membrane and

a flat back with a brim extending in a direction outwardly

of the back.

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(f) Legun—French Patent 2,199,266

This patent discloses a sac that can be inflated with

isotonic saline solution after being implanted by use of

a hypodermic needle through the tissue.

(g) Lynch—U:5S. Patent 3,383,902

This patent discloses an implantable prosthesis

having two lumens that permits the addition of material

after implantation.

(h) Arion—U.S. Patent 3.860.969 and Mohl et al—

U.S. Patent 3.663.968

Both of these U.S. patents disclose implantable

prostheses with a chamber constructed of two separate

materials for the front and back walls.

(i) Schulte—U.S. Patent 3,310,051

This patentee. Schulte. is the same Rudolph Schulte

who is a joint patentee in the Radovan-Schuite tissue

expander patent in issue in the litigation.

This Schulte patent discloses a surgically implant-

able reservoir having a front wall and a rear wall of

different thicknesses. It appears that due to the relative

differences in thicknesses between the two walls, the

second wall would be inherently more flexible than the

rear wall.

(j) Heimlich—U.S. Patent 3,605,749 and Schiff—

U.S. Patent 3.656.873

Each of these U.S. patents discloses surgical devices

incorporating a check valve similar to that disclosed in

the Radovan-Schulte patent. In the Heimlich patent, the

element 17 is the valve. In the Schiff patent, the valve

is illustrated in Figure 3 as elements 34 and 36.

These patents establish the use of stiff-backed bases for

prostheses of various configurations.

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B. Prior Art, Contrasted to the Claims of the 4,217,889 Patent

27. The Hartley, Jr.. patent 3.934.274 and the Perras et

al patent 3,665,529 were relied on by the patent examiner as

examples of implantable prostheses and were distinguished

over by counsel that neither taught expansion of the prosthesis

after implantation without surgical re-entry.

28. The Sanders et al patent 3,919,724 disclosed a device

that was totally collapsible. except for the valve, during

insertion, but was not considered by the patent examiner.

29. The Perras et al U.S. patent 3,681,787 disclosed a

breast prosthesis with a solid non-extensible rubber rim but

was not considered by the patent examiner.

30. None of the prior art patent seferences taught or

specifically suggested the use of a tissue expander, as con-

trasted to prior art prostheses of Finding No. 26, having a

base that is substantially non-extensible, either inflexible or

stiffly flexible. thereby causing its area shape to be retained.

The stiffness of the Radovan expander base prevents excessive

localized forces from being exerted beneath the base or against

underlying muscle in a tissue expander. Radovan and Schulte

addressed this problem of the prior art balloon-type tissue

expanders.

C. Mentor-Dow License (Exhibit 309)

31. Mentor asserted the ‘889 patent against the Dow

Corning Corporation (Dow) of Midland. Michigan. Dow

advised Mentor of their claim of file wrapper estoppel in the

Radovan et al file history. Exhibit 285. This is the same

position as the defendants found to be true.

32. Mentor granted Dow a non-exclusive license under

the ‘889 patent to make. use and seli tissue expanders of a

special type. Mentor and Dow agreed royalties were due

Mentor provided the Dow tissue expanders have a base which

is reinforced such that the base does not stretch throughout

its area.

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D. The Level of Ordinary Skill in the Art

33. Based on the prior art patent teachings and know-

ledge of tissue expanders of various designs, the level of

skill required to design a tissue expander would require the

application of the level of skill associated with a medical

doctor practicing tissue expansion and breast reconstruction.

The doctor should have a familiarity with human physiology

and the mechanical properties and biocompatability of

synthetic polymers.

E. The Non-Obviousness of the 4,217,889 Patent

34. The Court is of the opinion that none of the prior

art, either cited by the Patent Office or the additional art

cited by the defendant, would lead one skilled in the art to

use a tissue expander having a substantially non-extensible

base as claimed immediately prior to the filing of the original

Radovan et al patent application on September 15, 1976.

III. Infringement

A. The Accused “Versafil” Exnander

35. Cox-Uphoff manufactures, uses and sells tissue

expanders that are sold as the “Versafil” tissue expanders.

The “Versafil” tissue expanders are produced with “backing”

and unbacked expanders. Only the backed expanders were

accused to infringe.

36. The defendants’ backed “Versafil” tissue expanders

are constructed of two layers forming a flat envelope with the

base and cover overlying one another in a flat condition when

empty (“zero volume”) and have an opening in the base.

The opening includes a normally closed valve that opens in

response to the insertion of a fill tube therein. The opposite

end of the fill tube is adapted to receive a fluid such as air or

a Saline solution to rapidly introduce the fluid into the

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envelope to expand it. The fill tube is removable and when

removed, it allows the valve to close again. The envelope

can be continuously expanded by means of a reservoir-fill

tube combination connected to the envelope. Hypodermic

injections introduce fluid into the reservoir for periodic

expansion of the envelope.

37. The defendants’ “Versafil” tissue expander comprises

a balloon flexible in all directions when expanded by a tube

passing through the skin, both the design and performance

of which come within the teachings of the prior art.

38. The defendants established that the “backed”

“Versafil” tissue expanders include an injection port (a “less

expandable puncture chamber”), and an all silicone envelope

(a “skin stretching chamber”) onto which a piece of silicone

sheeting is bonded. This silicone sheeting has approximately

the same hardness or durometer reading as the envelope.

Neither the sheeting nor the envelope would be considered

to be either rigid or stiff. The shape of either the inflated or

uninflated “Versafil” tissue expanders are not determined by

the sheeting bonded to one side of the envelope, but by the

shape of the mandrel on which the envelope is cast.

39. The defendants further established that in clinical

use, a “Versafil” tissue expander is inflated with saline by

“periodic hypodermic injections through the skin into the

puncture chamber.”

40. The inflated tissue expanders illustrated in Figures

4-13 in the Radovan et al ‘889 patent all have perfectly flat

bases.

41. The inflated “Versafil” tissue expanders of the defen-

dants have both the envelope and the sheeting extended.

42. The defendants also established that on the “Ver-

safil” tissue expanders. the sheeting bonded to one side of the

envelope is there for the purpose of hiding cosmetic flaws in

the envelope and to make the tissue expander a little easier

to insert into the surgical pocket.

A-24

‘

43. It is apparent to both those who use and to those

who design tissue expanders that a tissue expander is still

clinically functional without a non-extensible or shape-retai-

ning base.

44. The Radovan-Schulte patent in suit, No. 4,217,889,

is directed to a flap development device or tissue expander

as defined by apparatus claims that have been accused as

being infringed, namely, claims 23-27 and 29. Apparatus

claim 23 of said patent reads as follows:

Claim 23. A device to progressively increase skin area

over a prolonged period of time after surgical implanta-

tion, comprising:

(a) a highly expandable skin stretching chamber

joined in flow communication with a substantially

less expandable puncture chamber;

(b) said skin stretching chamber having a shape

retaining base that 1s substantially stiffer than a

flexible cover of the skin stretching chamber for

controlling the shape of such skin stretching chamber

during progressive enlargement; and

(c) the skin stretching chamber is collapsible to a

volume substantially less than one half of its inflat-

able volume for insertion under a section of skin,

whereby the skin stretching chamber can be progres-

sively enlarged by periodic hypodermic injections

through the skin into the puncture chamber.

Apparatus claims 24 through 27 and 29 are all dependent

claims and dependent on claim 23. Claim 23 is controlling.

45. The Radovan-Schulte patent in suit No. 4,217,889

is also directed to a method of progressively increasing skin

area. The method claims that have been accused as being

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infringed are claims 30 and 31. Method claim 30 of said

patent reads as follows:

Claim 30. A method of progressively increasing skin

area over a prolonged period of time, comprising the

steps of:

(a) placing beneath the skin a device that includes

a highly expandable skin stretching chamber joined

in flow communication to a substantially less ex-

pandable puncture chamber, said skin stretching

chamber having a base that is substantially stiffer

than a flexible cover of the skin stretching chamber,

and such skin stretching chamber 1s collapsible to a

volume substantially less than one half of its inflat-

able volume for insertion under a section of skin;

and

(b) progressively enlarg:ng the skin stretching cham-

ber by periodic hypodermic injections through the

skin into the puncture chamber.

Method claim 31 is a dependent claim that is dependent on

claim 30 and therefore method claim 30 1s controlling. Both

method claims 30 and 31 include the structural feature of the

tissue expander defined in claim 23. namely, a tissue expander

(“a device”) “having a base that is substantially stiffer than a

flexible cover of the skin stretching chamber”.

B. Infringement

46. A-physical examination of the Mentor tissue ex-

panders demonstrates. clearly. the rigidity of the base element

thereof must be substantial in order to distribute the fluid

pressure within the chamber evenly over the base in order to

effect the result of the Radovan et al patent claims.

47. A physical examination of the base of the accused

“Versafil” tissue expander demonstrates that the base 1s not

substantially stiffer than the flexible cover of the stretching

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chamber and therefore does not have a “shape retaining base”

to effect the result of Radovan patent claim 23, element (b),

as recited in Finding 23.

C. Vexatious or Unjustified Infringement Claim

48. Prior to the initiation of the litigation and during

the pre-trial proceedings in the litigation, Mentor did not

specifically apply the Radovan et al patent claims to the

Cox-Uphoff accused tissue expanders. Typical of Mentor’s

discovery responses are the Mentor Answers to Interrogato-

ries 1, 2 and 4 as late as March 11, 1988, Exhibit 271,

concerning the infringement claim. The response to Interrog-

atory No. | was supplemented by Exhibit 276, but not the

response to Interrogatory No. 2. It is incredible that a patent

owner could assert infringement of patent claims without

revealing the application of the patent claims to a defendant’s

accused structures. long after commencing the litigation.

49. Mentor’s Memorandum of Contentions of Fact and

Law submitted in June, 1988, discussed the issue of infringe-

ment of the Radovan patent claims and the willful infringe-

ment of Cox-Uphoffs “stiff-backed” tissue expander as being

“literally” covered by the accused patent claims in broad,

general terms. A “detailed description” indicating the alleged

representation of the manner the patent claims were infringed

was attached to Mentor’s Memorandum as Exhibit “C”.

The critical aspects of the patent claims were supported by

conclusionary statements, such as the following statement as

to patent claims 23:

“The CUI chamber has a shape retaining base that

is reinforced with fabric mesh and 1s substantially

stiffer than the flexible cover of the stretching

chamber.... The base controls the shape of the

stretching chamber during enlargement.”

50. Mentor’s expert patent witness testified on infringe-

ment. without reference to the prior art and the validity of

—

|

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the patent claims, other than the presumption of patent

validity, and applied them literally without any limitations

as to the proper legal interpretation of the patent claims in

the broad fashion represented in Finding No. 48. At no

time was any proof submitted that the Cox-Uphoff tissue

expanders were (1) flexible in all directions when expanded,

(2) nor that the sheeting in the base of the “backed” Versafil

expanders is rigid or stiff, (3) the base of the “Versafil”

expander is substantially stiffer than the flexible cover of the

stretching chamber to provide a “shape retaining base” as the

Radovan patent claims.

BECKER PATENT 4,643,733

51. The Becker ’733 patent discloses a single lumen

mammary implant that is claimed to function in the capacity

of a tissue expander capable of multi-directional expansion

and capable of being expanded by percutaneous fluid injec-

tions or delayed filling into a reservoir or port connected by

an attachable-detachable fill tube with the implant. When

the implant is within the body, it may be periodically inflated

by means of hypodermic injections through the body and

into the reservoir for expanding the implant without the need

for additional surgical re-entry. The completely expanded

implant may have the reservoir and fill tube detached from

the implant upon opening the body, and the detached implant

maintained in the body permanently. The implant per se,

including the valving. therefore, is based on the permanent

breast prosthesis of Heyer-Schulte, the admitted prior art, as

noted in the original Becker patent application as filed in the

Patent and Trademark Office and now in the patent in column

2. lines 50-61, of the ‘733 patent. The Radovan ‘889,

discussed hereinabove. was admitted to be prior art by Dr.

Becker in his patent application as originally filed and now

in his patent in column 2, lines 22-29.

The History of the Becker 4,643,733 Patent Application

52. The Becker patent application as filed in the Patent

and Trademark Office on April 4. 1983. was marked up by

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the applicant Becker. beginning with the title and through

the Declaration executed by Hilton Becker on March 22,

1983. The marked-up application deleted certain matters

and substituted other language therefor and added certain

matters. The Declaration (that was previously executed) was

similarly marked up. All the markings were initialed by the

applicant and dated 3/23/83 in the margins of the application

papers as filed in the Patent Office: see Exhibit 140.

An unmarked. unexecuted copy of the Becker patent

application, Exhibit 219. reveals the language deleted from

the application as filed in the PTO. A significant change

reveals that the term “a delayed filling” was substituted fro

the blocked out words “subcutaneous expander” throughout

the specification, patent claims, Declaration, and verified

statement (declaration) claiming small entity status 37 CFR

1.9(f) and 1.27(b)—independent inventor.

53. The Declaration executed by the applicant Becker

was in the usual form and included the acknowledgment of

the duty to disclose information of which the applicant

was aware and material to the examination of the patent

application. The applicant Becker testified at the trial that

he discussed this “duty to disclose” with his then patent

attorney (decreased prior to issuance of the patent in suit)

and he understood his “duty to disclose.”

54. Priorto any examination of the Becker patent appli-

cation by the Patent Office, the applicant’s counsel attempted

to comply with the “duty to disclose” by filing a “Statement

Under 37 C.F.R.41.56” identifying certain information that

may be material to the examination of the patent application.

The statement included a listing of the prior art and copies

of each of the identified items. This information includes

the prior work of Radovan disclosed in the patent specifi-

cation, namely, the Radovan et al ‘889 patent and Dr. Rado-

van’s prior publication and the Heyer-Schulte prior devices.

See column 1, lines 22-62. of the ’733 patent.

ee

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55. The ’733 patent specification includes the material

of the original application directed to the problem of the

prior art implants, namely, the requirement for “two major

surgical procedures.” The first procedure required the inser-

tion and use of a tissue expander for expanding the breast

tissue and then removing the expander and substituting a

permanent implant in the position of the expanded tissue;

column 1, line 63, to column 2, line 8, of the ‘733 patent.

56. The ’733 patent claims to eliminate the need for

two surgical steps by requiring only a single major surgical

procedure. This was accomplished by the provision of “a

singular device which functions both as an expander and as

a permanent implant.” The implant is gradually expanded

by percutaneous injections into the implanted reservoir for

tissue expansion purposes. Upon completion of the expan-

sion procedure, the reservoir and filling tube can be detached

from the implant and removed from the body through a

single small incision; column 2, lines 11-23, of ’733 patent.

57. All of the original patent application claims were

identically descriptive of the tissue expander of the admitted

prior art, namely, the Radovan ’889 patent, and Radovan

publications as recited in Finding No. 55.

58. Patent examiner Ronald L. Frinks, a primary exam-

iner, examined the Becker application and the prior art,

including the prior art cited by the applicant and made all of

the prior art of record in the Becker patent application. All

of the original, principal Becker patent application claims

were rejected by Examiner Frinks as unpatentable under 35

USC 103 over the teachings in either the citation of the

Dow Corning publication or the Heyer-Schulte “Inflatable

Mammary Prosthesis” publication in view of the teachings

of the Radovan et al ‘889 patent. The examiner indicated it

was an obvious expedient of choice to provide an attached

reservoir on the detachable fill tubes to facilitate percutaneous

injection fillings after implantation as the ’889 Radovan et

al patent taught such a feature to be old in the art.

EE

A-30

59. In responding to the Office’s rejection of the Becker

claims, Becker's counsel did not amend any of the claims but

argued for patentability. In counsel’s arguments he, again,

acknowiedged that the Radovan expander was a “temporary

expander” of the prior art and the “permanent implants”

utilized a relatively rigid filling tube that excluded them from

long-term attachment to a filling reservoir (4 to 8 week period

during expansion).

60. Prior to further action by the patent examiner, a

Supplementary Response to the rejection was filed by Becker.

This supplemental response included the affidavit of H. Hollis

Caffee, M.D., and his evaluation of the prior art. Dr. Caffee’s

knowledge was that no singular device was used to perform

skin expansion and then left in place as a permanent

implant prior to the disclosure in Becker’s patent application.

Dr. Caffee was of the opinion it would not be obvious to one

skilled in the art to add a detachable reservoir to either the

cited Hever-Schulte or Dow Corning implants.

61. On re-examination. Examiner Frinks rejected the

principal claims 1-5 as being “structurally anticipated” by the

Radovan et al *889 patent under 35 USC 102. The examiner

established the identity of the claimed subject matter and the

teachings of the ‘889 patent.

Method claim 9 was allowed by the examiner. and indi-

cated dependent claims 6-8 contained allowable subject

matter.

62. Becker's patent counsel personally interviewed

Examiner Frinks and discussed an amended version of origi-

nal claim | and presented an amendment. The amendment

of claim | was claimed to distinguish over the cited art by

amending the characterization of the prosthesis as being

“constructed substantially entirely of a relatively scft and

flexible material.” The claims were then allowed by the

examiner and appear in their amended form in the ‘733

patent.

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I. Validity of the Becker 4,643,733 Patent

The Scope and Content of the Prior Art

63. The references before the Patent Office were as

follows:

(a) Radovan et al—Patent No. 4,217,889

Issued August 19, 1980 on “Flap Development

Device and Method of Progressively Increasing

Skin Area”

Claim 4 and lines 4-45 describe a tissue expander

device which has a normally closed check valve and

remote reservoir for fluid addition and removal. That

reservoir is connected to the prosthesis in such a way

that it is disconnectable through a small incision with

the prosthesis remaining implanted.

(b) Boone—Patent No. 3,600,718

Issued August 24, 1971 on “Inflatable Prosthesis”

This patent discloses an inflatable mammary pros-

thesis with a removable filling stem. At the point of

introduction of the filling stem through a hole in the

Shell, there is a capsule of sealing gel through which

the stem passes. After implantation, the stem can be

withdrawn and the capsule seals the mammary. Boone

also considers the possibility of leaving the filling stem

in the patient for addition or withdrawal of fluid at a

later time and then the stem withdrawn. Boone does not

say how the implanted fill stem is accessed at a later

time; but with the advent of tissue expander reservoir

filling ports in later years, it would appear obvious to

one skilled in the art to use such a reservoir with Boone’s

invention.

(c) Lynch—Patent No. 3,883,902

Issued May 20, 1975 on “Variable Volume Pros-

thetic Assembly”

_

A-32

This patent describes a breast prosthesis that 1s

capable of being filled via a removable connecting tube

attached to a reservoir of fluid. A valve is provided

within the tube for closing the tube after the fluid is

dispensed.

(d) Lake—Patent No. 4,095,295

Issued June 30. 1978 on “Adjustable, Fluid

Filled Breast Implant”

This patent describes a breast prosthesis without

valves but with a filling tube for remote filling of the

prosthesis after implantation. The remote valve can be

accessed without major surgery for altering the volume

of the prosthesis. Lake also mentions that fill tubes can

be removed altogether from similar prostheses (lines

1-55).

(e) Austad—Patent No. 4,157,085

Issued June 5, 1979 on “Surgically Implantable

Tissue Expanding Device and the Method of

Its Use”

This patent describes a tissue expanding device that

is formed of a permeable membrane inside which is

material that establishes an osmotic potential for filling

of the prosthesis with extracellular fluid. This device is

also known as a self-inflating tissue expander. Though

usually a temporary implanted device, Austad suggests

that sometimes the device is not removed after the tissue

has been expanded (permanent implant) (lines 2-20).

(f) Edmunds, Jr. et al—Patent No. 3,831,583

Issued August 27, 1974 on “Implantable Bulb

for Inflation of Surgical Implements”

This patent describes an implantable bulb attached

to an inflatable sac. The bulb is a reservoir which is

designed to self-seal after needle puncture so that fluid

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can be injected into the inflatable sac connected by a

filling tube to the bulb. The system is totally implantable

for long term or permanent use and yet is later controll-

able without surgery.

(g) Koneke et al—Patent No. 3.852.833

Issued December 10. 1974 on “Breast Prosthesis”

This patent describes a breast prosthesis which is

inflatable via a removable filling tube. There is contained

within the prosthesis a sealing device which seals the

prosthesis from leakage after removal of the tube.

(h) Buuck—Patent No. 3.863.622

Issued February 4. 1975 on “Incontinence

System and Methods of Implanting and Using

Same”

This patent describes an inflatable cuff for the ure-

thra. It includes a remote reservoir(s) connected by

filling tubes to the cuff which allow post implantation

inflation and deflation of the cuff. The system utilizes a

number of valves to control flow and prevent unwanted

leakage from the cuff.

(i) “Silastic Varifil Mammary Implant”

Dow Corning Brochure dated October, 1977

This brochure describes an inflatable breast prosthe-

sis which contains an inlet opening with a normally

closed valve and a detachable fill tube which can be

removed after implantation.

(j) “Inflatable Mammary Prosthesis”

Heyer-Schulte Brochure No. 102031-002-02-280

This brochure describes an inflatable mammary

prosthesis which contains an inlet opening and a nor-

mally closed valve and a detachable filling tube.

a

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64. The following additional references not before the

Patent Office were relied on by the defendants at the trial to

further show the state of the art:

(a) Berson—Patent No. 4,246,893

Issued January 27, 1981 on “Inflatable Gastric

Device for Treating Obesity”

This patent describes a device that 1s used to distend

the stomach in order to reduce food intake. The device

consists of a balloon with an attached filling tube and a

reservoir for adjusting the volume of the balloon on a

permanent basis.

(b) U—Patent No. 4,341,218

Issued July 27, 1982 on “Detachable Balloon

Catheter”

This patent describes an inflatable, implantable bal-

loon with a detachable filling catheter and a valve in the

balloon to prevent leakage. The device is designed with

a needle puncturable site (reservoir) at the end of the |

filling tube. The Becker device appears to contain all

the elements of the U device, namely, (1) an inflatable

balloon adapted for implantation with an inlet opening,

(2) a normally closed valve in the opening, (3) a filling

tube having one end detachably connected, and (4) a

reservoir connected to the other end of the filling tube

to controllably expand the device after implantation.

(c) Schulte—Patent No. 3.310.051

Issued March 21. 1967 on “Surgical Reservoir

for Implantation™

This patent describes a device for surgical implanta-

tion which can be used as a reservoir for tubular connec-

tion with a selected region or area. The reservoir is

used to add and withdraw fluid percutaneously from the

selected area.

eo

A-35

(d) Cox. Jr.—Patent No. 4,178,643

Issued December 18. 1979 on “Valve for Inflat-

able Prosthesis”

This patent describes a valve which can be used for

sealing an inflatable prosthesis after detachment of a

filling tube from the conduit of the valve. Claim 6 of

the patent describes an inflatable prosthesis with an

aperture and a valve attached to it. A fill tube may be

detachably connected to the prosthesis for fluid

adjustment.

(e) Bernhardt—Patent No. 2,698,436

Issued January 4, 1955 on “Bust Form”

This patent describes a breast prosthesis which is

designed with a valve means through which the volume

of the prosthesis may be replenished through the life of

the device.

(f) Fountain—Patent No. 3,492,996

Issued February 3, 1970 on “Ventriculo-Atrial

Shunt”

This patent describes a device for implantation into

the brain for treating hydrocephalics. The device consists

of a conduit for fluid addition, a conduit for fluid outlet,

an inter-connecting system including a pump. and a one-

way Valve.

(g) Cohen—Patent No. 4.433.440

Issued February 28, 1984 on “Prosthesis Formed

by Inner and Outer Inflatable Containers”

This patent describes a breast prosthesis comprised

of an inner and outer lumen each with self-sealing valves

with removable fluid filling tube(s).

(h) Bonnar—Patent No. 3.646.929

Issued March 7. 1972 on “Female Incontinence

Device”

A-36

This patent describes a device comprising a balloon

which is expandable via a connecting tubing attached to

a reservoir. A valve is included along the tube for

retaining fluid in the balloon. The balloon is inflated

and deflated for use as a female incontinence device via

the attached reservoir.

(1) Heimlich—Patent No. 3.672.372

Issued June 27. 1972 on “Urinary Drainage

Method™

This patent describes a device useful for urinary

drainage which comprises a flexible tubing attached at

one end to an inflatable balloon and its other end to a

valve.

(j) Hartley—Patent No. 3.934.274

Issued January 27. 1976 on “Deflatable Mam-

mary Augmentation Prosthesis”

This patent describes a delayed adjustable mamman

prosthesis comprising two sacs. one with an inlet opening

with a normaily closed valve through which a filling tube

is detachably connected. The other end of the filling

tube is designed for attachment to the end of a syringe

or other liquid reservoir.

(k) Sanders—Patent No. 3,919,724

Issued November 18. 1975 on “Implantable

Prosthesis Having a Self-Sealing Valve”

This patent describes a delaved filling breast implant

with a valve in the wall of the prosthesis for a filling tube

to detachably connect to the prosthesis for inflating the

implant. One embodiment described by Figure 6 and

lines 3-6 suggests a seif-sealing filling site connected to a

tube which can be penetrated by a needle in order to

inflate a (balioon) cuff.

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65. The reterences not before the Patent Office include

certain publications of the applicant-patentee Becker relied

on by the defendants at trial and include the following:

(a) “Breast Reconstruction Using an Inflatable

Breast Implant with Detachable Reservoir” published in

“Plastic and Reconstructive Surgery” for April, 1984.

The publication indicates “received for publication

December 9. 1982. revised June 27, 1983”; Exhibit 223.

In this publication Dr. Becker evaluated his discovery

on page 678 as follows:

~

the standard Heyer-Schulte type inflatable

breast implant has been modified to enable a reser-

voir to be attached and detached at a side filling

valve. The breast implant. therefore, functions ini-

tially as a tissue expander and then remains in

position aS a permanent once the reservoir 1s

removed.”

In this same publication, Dr. Becker stated on page 680

as follows:

“Since first described the inflatable breast implant

has undergone several changes. Initially, the filling

tubes were fixed to the implant, the newer implants

now have selfsealing valves with detachable filling

tubes by attaching a reservoir to the filling tube a

regular inflatable breast implant is converted into a

tissue expander.”

On page 678, Dr. Becker states:

“Over a period of twenty months, twenty-five cases

representing twenty-three patients with a total of

thirty-four breasts have been operated on using this

implant.”

(b) “The Permanent Tissue Expander” published

in “Clinics in Plastic Surgery.” Vol. 14, No. 3, July, 1987,

Exhibit 206.

—_——— aati

A-38

As late as July. 1987, Dr. Becker was still publishing how

he came about producing his Permanent Tissue Expander.

On page 519 of Exhibit 206. he states as follows:

“This concept was initially achieved by attaching an

injection dome to the free end of the filling tube

that is commonly used to inflate a saline-inflatable

implant.”

(c) “Breast Reconstruction After Modified Radical

Mastectomy.” Southern Medical Journal. Vol. 75, No.

11, pages !335-1338. November. 1982: note page 1337

in particular re the leakage problem of a single lumen

saline fillable mammary implant; Exhibit 227.

66. During the pendency of the Becker patent applica-

tion and after entering into the license agreement with Mentor

recited in Finding No. 13, Mentor sought approval for sale

of a reverse double lumen, delayed filling implant from the

Federal Drug Administration (FDA), Exhibit 276. The FDA

submission identified and discussed the prior art devices and

equivalency. None of this prior art was made of record in

the Becker patent application record and was not considered

by the patent examiner. This was relied on by the defendants

at the trial.

67. The Mentor submission to the FDA included a

reference to a publication of Drs. Birnbaum and Olsen enti-

tled “Breast Reconstruction Following Radical Mastectomy

Using Custom Designed Implants.” Plastic and Reconstruc-

tive Surgery, 61:3. pages 355-363, 1978; see page 8, reference

4 of Exhibit 276.

(a) The Mentor’s FDA submission of December 5,

1984, on page 7. represented to the FDA the following:

“A method similar to that discussed in this submis-

sion was presented by Dr. Lawrence Bimbaum and

Dr. John Olsen at the American Society for Aesthetic

Plastic Surgery Annual Meeting in March. 1977.

A-39

Their series of 37 patients underwent breast recon-

struction with inflatable implants serially expanded

by the addition of saline. The implant was expanded

over a period of several months until the desired

volume is achieved. The inflatable implant either

then remained in place as a permanent implant or

was exchanged for a gel prosthesis.

(b) On pages 4-6 of Mentor’s December, 1984,

submission. they disclosed the equivalent devices that

were marketed prior to May 28, 1976. On pages 5 and

6, fifteen “equivalent prostheses” that were currently

manufactured and marketed were listed. This listing

included the Gel-Saline Filled Reverse Double Lumen

Mammary Prosthesis of Cox-Uphoff International. In

summarizing the equivalence on page 6 of Exhibit 276,

Mentor represented to the FDA as follows:

“The Mentor Expander Mammary Prosthesis

shares specific design characteristics and compo-

nents with several of the above referenced devices.

The reverse-double lumen design of an inflatable

saline-filled envelope surrounded by a gel outer

lumen is currently marketed by Cox-Uphoff Inter-

national (#8 above). The valve used in the Mentor

Expander Mammary Prosthesis is the retention

valve currently being used in the Mentor Inflatable

Mammary Prostheses (#1 above). The reservoir

and tubing connections used for expanding the

prosthesis are the same as those used in the Mentor

Radovan Tissue Expander (#7 above). The valve

through the gel portion of the implant 1s similar

in design to the Surgitek” Gel/Saline Mammary

Implant (#11 above). in which saline is injected

into the silicone gel.”

68. Dr. Becker admitted at trial that he had knowledge

of the Birnbaum-Olsen publication of Finding No. 67. but

did not call the patent examiner's attention to it since he was

A-40

of the opinion that it was equivalent to the Lake U.S. patent

4,095,295, which he did call to the Examiner's attention.

69. Dr. Becker did not disclose to the patent examiner

his prior knowledge of the fact that single lumen implants

leak. A single lumen, saline fillable implant is the only

embodiment disclosed in the ’733 patent; see Exhibit 227

recited in Finding No. 65(c). Dr. Becker had knowledge of

the leakage problem per his publication recited in Finding

No. 65(c).

70. After experiencing deflation problems with his single

lumen device, Dr. Becker sought the aid of the defendants

for solving the deflation problem. Dr. Becker discussed the

problem with Cox-Uphoff’s president, and he suggested a

solution through the use of the Cox-Uphoff reverse double

lumen implant; Exhibits 36, 50, 234 and 235. Mentor

commercialized the Becker concept in terms of a reverse,

double lumen implant.

Prior Art, Contrasted to the Claims of the 4,643,733 Patent

71. The prior art Radovan et al ’889 patent identically

discloses the subject matter of Becker patent claim 1, except

for the language added by amendment, namely, the prosthesis

being “constructed substantially entirely of a relatively soft

and flexible material” and the inlet opening for the prosthesis

forming a relatively smooth exterior surface upon detachment

of the filling tube.

72. The amendatory material referred to in Finding No.

71 is identically disclosed in the Heyer-Schulte Inflatable

Mammary Prosthesis, which was admitted by Becker in the

PTO to be prior art and is so described in column 1, lines

50-62. of the ‘733 patent.

73. The publication of Dr. Becker referred to in Finding

65(a), page 678, of Exhibit 223 is an admission by Dr. Becker

that his patent claim | is descriptive of the “standard Heyer-

Schulte type” implant of the acknowiedged prior art that has

_

A-4]1

a means of injecting the saline solution into the implant by

way of “a reservoir” of the type disclosed by Heyer-Schulte

(a syringe). The original Becker publication was submitted

for publication in December, 1982, and revised on June 27,

1983, shortly after filing his application in the PTO.

74. As late as July, 1987, immediately prior to com-

mencement of the litigation, Dr. Becker was still publishing

how he came about producing his Permanent Tissue Ex-

pander referred to in Finding No. 65(b). In that publication,

Dr. Becker admitted he attached “an injection dome to the

free end of the filling tube” of the prior art implant; page 516

of Exhibit 206

The Level of Ordinary Skill in the Art

75. To design a delayed filling implant of the type

disclosed in the Becker ’733 patent based on the technology

of the prior art disclosures would require the level of skill

associated with a medical doctor practicing tissue expansion

and breast reconstruction. These practices were common to

plastic surgeons in the late 1970's.

The Obviousness of the 4,643,733 Patent

76. The known, acknowledged prior art inflatable breast

implant manufactured by Heyer-Schulte was admitted to be

the implant that was modified by Dr. Becker in his publica-

tions to provide delayed filling so that the Heyer-Schulte

implant could function as a tissue expander and remain

in position as a permanent implant. Dr. Becker merely

substituted a prior art “reservoir” of the type disclosed in the

Radovan ‘889 patent for a prior art “reservoir” in the form

of a syringe to permit “delayed filling.”

77. The patent examiner apparently overlooked his orig-

inal analysis of the Becker patent application claims as repre-

senting a combination of the teachings of the Heyer-Schulte

implant in combination with the Radovan ’889 patent when

ee

A-42

he considered the amended patent claims tc overcome the

rejection on the basis of Radovan alone. The original analysis

of the examiner and his rejection of the claims was correct

and should have been reconsidered and the claims rejected.

78. In addition to Radovan, the prior art Berson U.S.

patent 4,246,893, Exhibit 257. disclosed a permanent implant

with augmentation or reduction by percutaneous injection or

removal of fluid by means of a subcutaneously implanted

reservoir. The Berson device included a reservoir, fill tube

and prosthesis made of a relatively soft and flexible material.

The fill tube of Berson was not detachable from the prosthesis

as disclosed.

79. The Birnbaum-Olsen publication of Finding No. 67

established the use of a single implant that is left in the

body permanently after expansion. contrary to Dr. Coffee’s

understanding, prior to Becker.

80. In Dr. Becker’s publication referred to in Finding

No. 65(a) (Exhibit 223), it was indicated as being revised for

the last time on June 27, 1983. less than four months after

the Becker filing date. This publication was an admission by

Dr. Becker of the commercial usage of his invention more

than one year prior to the filing of his patent application.

CONCLUSIONS OF LAW

1. This is a patent suit brought under the patent laws

of the United States. 35 U.S.C. Ys 1-293. The Court has

jurisdiction of the parties and of the subject matter of this

action by virtue of 28 U.S.C. 9's 1338 and 2201. There is an

actual controversy between the parties concerning the subject

matter of this action: 28 U.S.C. 2201. Further. the Court has

determined that venue is properly laid in this district under

28 U.S.C. 1400(b).

2. Plaintiffs. Mentor. have the burden of establishing by

a preponderance of evidence that Cox-Uphoffs products

A-43

have infringed the claims of either the ‘889 and/or the ‘733

patents.

3. Defendant Cox-Uphoff. have the burden of establish-

ing invalidity or unenforceability of the claims of the ’889

and/or the ‘733 patents. A patent is presumed to be valid

pursuant to 35 U.S.C. 282.

4. The grant of a patent by the U.S. Patent and Trade-

mark Office bears a presumption of validity as to prior art

considered by the Patent Office. The burden of establishing

invalidity on the party asserting it is an important aspect of

the validity of a patent in suit and cannot be overlooked by

a Court; Solder Removal Company et al vs. U.S. International

Trade Commission et al 582 F. 2d 628, 632-633, 199 USPQ

129, 133, see notes 8. 9 and 10; TP Laboratories, Inc. v.

Professional Positioners, Inc. 724 F. 2d 965, 220 USPQ 577

(Fed. Cir. 1984): Stratoflex, Inc. v. Aeroquip Corp. 713 F. 2d

1530, 218 USPQ 871, 875, 876 (Fed. Cir. 1983).

5. The defense of lack of novelty or anticipation can

only be established by a single prior art reference which

discloses each and every element of the claimed invention.

Anticipation is not shown even if the differences between the

claims and the prior art reference are “insubstantial” and the

missing elements could be supplied by the knowledge of one

skilled in the art. Srructural Rubber Products Co. v. Park

Rubber Co. 749 F. 2d 707, 223 USPQ 1264, 1270 (citing

cases).

6. Under 35 U.S.C. 103 in order for a patent to be

granted by the Patent Office, the difference between the

subject matter sought to be patented and the prior art must

be such that the subject matter as a whole would not have

been obvious at the time the invention was made to a person

with ordinary skill in the art.

The statutory conditions of 35 U.S.C. 103 have been

considered by the United States Supreme Court and the

Court has established that certain factual inquiries need to

i

A-44

be made when there is no identity between the prior art

and the claimed invention for evaluation of the statutory

conditions that must be satisfied to render a patent valid. /n

Graham y. John Deere Co. 383 U.S. 1, 17, 15 L.ed. 2d 545,

86 S. Ct. 684, 148 USPQ 459. 466, 467, the Court indicated

on page 17 of 383 U.S. 1, that the inquiries should be:

“1. The scope and content of the prior art are to be

determined.

“2. The differences between the prior art and the

claims in issue are to be ascertained.

“3. The level of the ordinary skill in the pertinent

art resolved.”

As the Court indicated against this background, which

is a factual background, the obviousness or nonobviousness

of the subject matter is determined. The Court also indicated

that the secondary considerations, such as commercial suc-

cess, long felt but unsolved need, failure of others, etc., have

relevancy as to “nonobviousness”.

7. The “subject matter as a whole” refers to the subject

matter of each and every claims as a whole and not to the

individual elements of a claimed combination and their

individual novelty. Srratoflex, Inc. v. Aeroquip Crp. 713 F.

2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Jones v. Hardy 727

F. 2d 1524, 220 USPQ 1021, 1024 (Fed. Cir. 1984).

8. The Court of Appeals for the Federal Circuit has ruled

that these “secondary considerations” in Graham must always

be considered before reaching a conclusion under 35 U.S.C.

103; Jn re Sernake”, 702 F. 2d 989, 217 USPQ 1 (CAFC 1983).

9. The scope of the prior art relative to a patented

invention has been defined by the Court of Customs and

Patent Appeals (CCPA) as that “reasonably pertinent” to the

particular problem with which the inventor was involved. Jn

re Wood 559 F.2d 1032. 1036. 202 USPQ 171, 174 (CCPA

A-45

1979): Stratoflex, Inc. v. Aeroquip Corp. 713 F. 2d 1530, 218

USPQ 871. 876 (Fed. Cir. 1983).

10. The legal tests concerning the evaluation of the level

of ordinary skill in the art under 35 U.S.C. 103 is determined

by evaluating the various prior art approaches employed, the

sophistication of the technology involved, and the educa-

tional background of the workers in the art in accordance

with Orthopedic Equipment Co., Inc. vy. All Orthopedic Appli-

ances, Inc. 707 F. 2d 1376. 217 USPQ 1281, 1285 (Fed. Cir.

1983).

The educational background of the inventor of the patent

in suit is not a consideration. Environmental Designs, Ltd.

v. Union Oil Co. of California 713 F. 2d 693, 218 USPQ 865,

868, 869 (Fed. Cir. 1983).

11. Obviousness cannot be established under 35 U.S.C.

103 when there are no teachings or suggestions supporting a

claimed combination. ACS Hospital Systems, Inc. y¥.

Montefiore Hospital 732 F. 2d 1572, 221 USPQ 929, 933

(Fed. Cir. 1984).

The “subject matter as a whole” of aclaimed combination

must be evaluated to render a judgment of obviousness or

nonobviousness; see Srratoflex, Inc., Supra.

Radovan ‘889 Patent

12. On the basis of the Findings of Fact entered herein,

the Court has concluded that Cox-Uphoff has not proved by

clear and convincing evidence facts compelling a conclusion

of patent invalidity of claims 23-27, 29, 30 and 31 of the ’889

patent. Specifically. the Court has considered the presump-

tion of validity. 35 U.S.C. 282. and the evidence on invalidity

adduced at trial. and concluded that the subject matter of the

patent claims would not have been obvious to one skilled in

the art at the time of the application for the ‘889 patent

within the meaning of 35 U.S.C. 103.

A-46

13. The claims of the ‘889 patent must be construed the

same for both infringement and validity, SR/ International vy.

Matsushita Electric Corp. of America, 775 F.2d 1107, 1121,

227 USPQ 577, 585 (Fed. Cir. 1985).

14. In determining whether a device infringes a patent

claim, resort must be had in the first instance to the words

of the claim. If the accused device falls clearly outside of

the scope of a patent claim or any equivalents, correctly

interpreted, there is no infringement. Graver Tank Mfg. Co.,

Inc. v. Linde Air Products Co., 339 U.S. 605, 607, 608 (1950)

85 USPQ 328, 330. Each element of a patent claim must be

found in an accused device to support a claim of infringement.

Lemelson vy. United States, 752 F.2d 1538, 1551, 224 USPQ

526, 532-533 (Fed. Cir. 1984).

15. In light of the Findings of Fact entered herein, the

Court has concluded that the Cox-Uphoff “backed” “Versafil”

tissue expanders do not infringe within the meaning of 35

U.S.C. 271, any one of claims 23-27, 29-31 of the Radovan

et al patent ‘889. Mentor presented no proofs of infringement

of a properly interpreted patent claim. Fonar Corp. v. Johnson

and Johnson, 821 F.2d 627. 631-633: 3 USPQ 2d 1109, 1112-

1113 (Fed. Cir. 1987).

16. Cox-Uphoff is entitled to a Judgment in its favor as

to the “889 patent. and its costs.

Becker ‘733 Patent

17. The proofs and evidence adduced at trial establishes

that the defendant has met its burden of proving by clear and

convincing evidence of the facts establishing invalidity of the

Becker ‘733 patent. pursuant to 35 U.S.C. 282. Panduit Corp.

v. Dennison Mtg. Co., 774 F.2d 1082, 227 USPQ 337. 346-

347 (Fed. Cir. 1985).

18. On the basis of the Findings of Fact entered herein,

the Court has concluded that claims 1-4. 7 and 8 of the

Becker ‘733 patent are invalid. pursuant to 35 U.S.C. 103.

a

A-47

Specifically. the Court has concluded that the admissions of

Dr. Hilton Becker in evaluating his discovery reveals that the

modification of the standard Heyer-Schulte inflatable breast

implant, in attaching the prior art type of reservoir or dome

as a substitute for the prior art reservoir in the form of a

Syringe, 1S a substitution suggested and disclosed in the

Radovan et al ‘889 patent. or Berson ‘893 patent, so that it

was within the skill of the workers in the art. immediately

prior to the filing of the Becker patent application in the

Patent and Trademark Office. to substitute one known form

of reservoir for another known form of reservoir and, there-

fore, the subject matter of the Becker patent claims. taken as

a whole, was obvious and invalid under 35 U.S.C. 103.

19. The U.S. Patent and Trademark Office is not autho-

rized to issue patents whose effects are to remove existent

knowledge from the public domain or to restrict free access

to materials already available. Graham v. John Deere Co.,

383 U.S. 1, 6, 86 S. Ct. 684 (1966).

20. The conditions for patentability recited in 35

U.S.C. 102 include the loss of right to a patent if an invention

was in public use in this country more than one year prior to

the date of application for patent in the United States (see

(b) of 35 U.S.C. 102).

21. In light of the Findings of Fact entered herein, the

Court has concluded that the subject matter of the claims of

the ‘733 patent was in public use by Dr. Becker for more than

one year prior to the filing of the Becker patent application

in the Patent and Trademark Office. based upon Dr. Becker's

admissions in his publication so stating and, therefore, the

patent claims are invalid.

22. If any Finding of Fact is construed as a Conclusion

of Law, or any Conclusion of Law herein is construed as a

Finding of Fact. the same is deemed to be such.

DATED: February 27. 1989

Jesse W. CurTIS

Jesse W. Curtis

United States District Judge

A-48

IN THE UNITED STATES District COURT

FOR THE CENTRAL DISTRICT OF CALIFORNIA

MENTOR CORPORATION, e/ al..

Plaintifis.

v. 4

Cox-UPHoOFF CORPORATION.

No. CV 87-561 1-JWC(Tx)

JUDGMENT

Defendant. 4

In accordance with the foregoing Findings of Fact and

Conclusions of Law, it is ordered, adjudged, and decreed as

follows:

1. That this Court has jurisdiction of the subject matter

and of the plaintiffs and defendant.

2. That plaintiffs are the owners of all right, title and

interest in, to and under the Letters Patent of the United

States Nos. 4,217,889 and 4,643,733.

3. That Letters Patent No. 4.217.889 and each and every

claim 23-27, 29-31 thereof are not invalid in law.

4. That Letters Patent No. 4.217,889 and none of the

claims 23-27, 29-31 have been infringed by the defendant.

5. That Letters Patent 4.643.733 and each and every

claim 1-4 and 7-8 is invalid under 35 U.S.C. 103 and

unenforceable.

6. That the subject matter of Letters Patent 4,643,733

was in public use more than one year prior to the filing of the

application for Letters Patent and therefore is barred under

35 U.S.C. 102 whereby each and every claim thereof is invalid

and unenforceable.

7. Thai the Complaint for infringement of Letters Patent

Nos. 4.217.889 and 4.643.733 is hereby dismissed as to

defendant Cox-Uphoff Corporation.

se

A-49

8. That defendant Cox-Uphoff Corporation shall recover

its taxable costs herein from plaintiffs in the sum of $

9. That pursuant to defendant Cox-Uphoff Corpora-

tion’s counterclaim it 1s hereby decreed:

a. That U.S. Letters Patent 4,217,899 and 4,643,733

and each and every claim of each are invalid, void and

unenforceable.

b. That the patents in suit are not infringed by any

device, made, used or sold by counterclaimant

DATED: February 27, 1989

Jesse W. CurTIS

Jesse W. Curtis

United States District Judge

A-50

IN THE UNITED States District Court

For THE CENTRAL DisTRICT OF CALIFORNIA

MENTOR CorrorRaTION, ef ail, : NO. CV 87-561 1-JWC(Tx)

Plaintifis. MEMORANDUM AND

. ORDER DENYING

DEFENDANT'S MOTION

Cox-UpHorr CORPORATION, TO AMEND FINDINGS OF

FACT, CONCLUSIONS OF

Defendant’ | L&W AND JUDGMENT, etc

4

The defendant moves for an order establishing that the

Becker Patent in suit was obtained by inequitable conduct

before the Patent and Trademark Office; for additional find-

ings of fact and conclusions of law establishing the “excep-

tional” nature of this litigation, and for the award of attorneys’

fees.

Plaintiffs challege the motion, arguing that this court 1s

without jurisdiction to consider the motion as it 1s untimely

Federal Rules of Civil Procedure 52(b) and 59(e) both require

a party requesting additional findings or an amended judg-

ment to make its motion not later than ten days after the

entry of judgment. It appears that this precise question has

been submitted to the court of appeals for the federal circuit

which has ruled against the defendant, but the matter ts still

before the court on a motion for rehearing filed by the

defendant. This being so, I do not consider it a proper issue

to be considered here.

However, even assuming the motion to be timely, it 1s

without merit and must be denied.

Cox-Uphoff contends that there is convincing evidence

that the Becker Patent was obtained by inequitable conduct.

This, he asserts. was accomplished by Becker making certain

alterations on his patent application after its execution but

before it was filed in the Patent Office contrary to 37 C.F.R.

1. 56(c( 4).

A-51

In my view. “execution™ involves more than merely

signing a patent application. Like a deed where delivery 1s

required, the “execution™ of a patent application requires

more than merely signing the document. There should be

some act beyond that indicating an intent to irretrievably

send it on its way to the Patent Office. I find no such evidence

in this case which would justify a finding that there was a

material alteration of the patent application after it was

executed. Furthermore. | find no clear and convincing evi-

dence that the patent failed to disclose material information,

or that the patent inggntionally withheld pertinent informa-

tion which the Paten? Office should have had.

Cox-Uphoff, in this motion, further moves the court for

an order declaring this to be an exceptional case justifying

the award of reasonable attorneys’ fees pursuant to 35 U.S.C.

§ 285. The purpose of this section in awarding attorneys’

fees in exexceptional cases contemplates such misconduct on

the part of a losing party as to constitute fraud on the Patent

Office. or so unfair and reckless as to make it unconscionable

for the prevailing party to sustain the expense of counsel.

Q-Panel Co. v. Newfield., 482 F.2d 210 (10th Cir. 1973). I

find no such evidence as would justify the award of attorneys’

fees in ths case.

If it 1s subsequently determined that this court has

jurisdiction to do so, and in the event of a reversal of this

court's judgment N.O.V. on appeal, the defendant's motion

for a new trial is granted on the ground that the verdict 1s

contrary to the substantial weight of the evidence and that

the award of damages 1s excessive

DATED: April 24. 1989

Jesse W. CurrTIs

Jesse W. Curtis

United States District Judge

A-52

United States Court of Apprals

for the Federal Cirruit

89-1302.-1348,-1472

MENTOR CORPORATION,

LinDA RADOVAN WILLIAMSON,

as executrix of the Estate of CHEDOMIR RADOVAN;

Hitton Becker. M.D.:; AND

BEVERLEY ANNE BECKER,

Plaintiffs-Appellants

}

Cox-UPHOFF CORPORATION AND

Cox-UPHOFF INTERNATIONAL

Defendants/Cross-Appellants

Judgment

ON APPEAL from the UNITED STATES DISTRICT COURT

CENTRAL DISTRICT OF CALIFORNIA

in CASE NO(S 87-5611 JWC

This CAUSE having been heard and considered,

itis ORDERED and ADJUDGED

REVERSED, REMANDED,

VACATED, AND DISMISSED

ENTERED BY ORDER OF THE COURT

DATED: Nov. 9, 1989 FRANCIS X. GINDHART

Francis X. Gindhart, Clerk

ISSUED AS A MANDATE: DECEMBER 21, 1989

COSTS: AGAINST CROSS-APPELLANTS

PII cc ccsccerdvnssctossens $970.93

United States Court of Apprals

for the Federal Circuit

A-54

ORDER

Before RICH, Circuit Judge. MAYER, Circuit Judge, and

MICHEL, Circuit Judge.

A petition for rehearing having been filed in this case,

UPON CONSIDERATION THEREOF, it is

ORDERED that the petition for rehearing be, and the

same hereby 1s, denied.

The suggestion for rehearing in banc is under

consideration.

The mandate will issue on December 21. 1989.

FOR THE COURT,

FRANCIS X. GINDHART

Francis X. Gindhan

Clerk

Dated: December 14, 1989

cc: ALAN M. ANDERSON

EDWARD J. DARIN

ARTHUR A. OLSON, JR.

MENTOR CORP V COX-UPHOFF, 89-1302, -1348 & -1472

Note: This order has not been prepared for publi-

Cation in a reporter.

ANCISB XK GiINCHART

‘A

A-5

INITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

717 MADISON PLACE, N.w

WASHINGTON, 0.C. 20439

December 15, 1989

Alan M. Anderson, Esq

Faegre & Benson

2200 N.W. Center

90 S. Seventh Street

Minneapolis, MN 55402

Re: Mentor Corp v. Cox-Uphoff, No. 89-1302, -1348 &

-1472

Dear Mr. Anderson:

The court has requested a response from appellants to

cross-appellants’ Suggestion for Rehearing In Banc.

Please file your response in accordance with Federal

Circuit Rule 35 on or before December 26, 1989.

Very truly yours,

Francis X. Gindhart

FXG:!d

cc: Edward J. Darin

Arthur A. Olson, Jr.

TELEPHONE 633-4580

AREA COOE 102

A-56

United States Court of Appeals

for the Federal Circuit

89-1302, -1348, -1472

MENTOR CORPORATION,

LINDA RADOVAN WILLIAMSON,

as executrix of the Estate of CHEDOMIR RADOVAN:

HILTON BEcKER, M.D.; aND

BEVERLY ANNE BECKER,

Plaintiffs-Appellants,

-

Cox-UPHOFF CORPORATION AND

Cox-UPHOFF INTERNATIONAL.

Defendants/Cross-Appellants.

ORDER

A-57

ORDER

A suggestion for rehearing in banc having been filed in

this case, and a response thereto having been invited by the

court and filed.

UPON CONSIDERATION THEREOF, it is

ORDERED that the suggestion for rehearing in banc be,

and the same hereby 1s. declined.

Judge Nies. Judge Bissell and Judge Archer would rehear

the case in banc.

FOR THE COURT

Dated: January 8, 1990 Francis X. GINDHART

Francis X. Gindhart

Clerk

cc: Alan M. Anderson

Edward J. Darin

Arthur A. Olson, Jr.

MENTOR CORP V COX-UPHOFF., 89-1302

DCT—87-5611 JWC

Note: This order has not been prepared for publica-

tion in a reporter.

EDWARD J. DaRIN

EDWARD J. DaRIN. INC.

301 East Colorado Blvd. ET ‘SS

Suite 518 _ CLERK. us DISTRICT CM |

Pasadena, CA 91101 ,

Tel. (818) 793-0689 | OCT = 1oge | |

|

| penn DISERICT GRCALES iif,

IN THE UNITED STATES DistRICT COURT

CENTRAL DISTRICT OF CALIFORNIA

Attorney for Defendants

) Civil Action No. 87-0561 1 JWC

MENTOR CORPORATION, ¢@! al, MOTION FOR JUDGMENT

Plainniti, | NOTWITHSTANDING

' | THE VERDICT AND

ALTERNATIVE MOTION

- FOR NEW TRIAL BY

DEFENDANTS PER

F.R.CIV.P.50(b)

Defendants. Hearing Date: Nov. 14. 1988

i Time: 10:00 A.M.

V.

Cox-UPHOoFF CORPORATION

etal.

Defendants move the Court to set aside the verdict

entered in the above action on September 23, 1988 and the

Judgment entered on October 4, 1988, and to enter Judgment

in favor of the defendants pursuant to the Motion of the

defendants for a directed verdict. The Motion of the defen-

dants for directed verdict should have been granted based on

the following grounds:

1. The evidence in the case showed conclusively that the

claims of U.S. patent 4.217.889 granted on August 19.1980 in

the name of Radovan. et al. are invalid under 35 U.S.C. 103,

when the subject matter of the claims are taken as a whole.

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2. The evidence in the case showed conclusively that

the defendants “Versafil” backed tissue expanders were not

infringements of apparatus claims 23 through 27, 29, and

method claims 30 and 31 of said Radovan et al patent,

and the claims cannot be validly expanded to cover the

defendants’ products, based on the prosecution history estop-

pel and/or the reverse doctrine of equivalents.

3. The plaintiffs’ relied on the presumption of validity

(35 U.S.C. 282) and no evidence was presented by the plain-

tiffs on the issue of validity as to both the patents in suit,

including the rebuttal of the defendants’ invalidating evi-

dence. Therefore. the evidence does not establish that plain-

tiffs are resorting to the same interpretation of the claims of

the Radovan et al ‘889 and Becker ‘733 patents for both

validity and infringement purposes. as the law requires.

4. In furtherance of the grounds detailed as to lack of

infringement, the trial evidence and the trial testimony of the

plaintiffs’ witnesses establish a lack of complete understand-

ing of the operation of the defendant's “Versafil” backed

tissue expanders and the correct sealing action in the lumens

of each of the two different designs of the defendant’s RDL-

Xpand mammary prosthesis. whereby to negate the jury

verdicts on infringement of the Radovan et al and Becker

patents and any claim of willful infringement.

5. The evidence in the case conclusively established

that the Claims of the Becker patent 4,643,733, granted on

February 17, 1987, are invalid under U.S.C. 103, based on

either the prior art (1) before the Patent Office, and/or (2) the

prior art not considered by the Patent Office (i.e. Berson

patent 4.246.893. Exhibit 257) when the subject matter of

each of the claims is taken as a whole.

6. The evidence in the case showed conclusively that

apparatus claim | through 4. 7 and method claim 8, were not

infringed by either design of the defendants’ expandable

mammary prosthesis indentified as the “RDL-Xpand™. The

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Becker patent claims cannot be expanded to cover the defen-

dants’ products, as the products are not equivalent to the

patented structures and basically are in the public domain

and not the patentee’s invention. The reverse double lumen

construction of each of the defendant's products and the

sealing of each lumen upon withdrawal of the filling tube by

means of the gel and/or plug is covered by the prior art,

including the Boone ’718 patent (Exhibit 248) and is outside

the scope of the Becker patent claims.

7. Claims 30 and 31 of the Radovan et al patent

4,217,889, and claim 8 of the Becker patent 4.643,733, are

all method claims and the evidence conclusively establishes

that there was no literal infringement by the defendants of

each of these claims. No jury instruction was given as

to infringement of a patent claim based on contributory

infringement or inducing infringement pursuant to 35 U.S.C.

271(b) or (c) and, therefore. the verdict is erroneous as not

supported by the evidence and not in accordance with the

law.

Becker—Inequitable Conduct

No verdict was returned by the jury on the inequitable

conduct facts and having been discharged by the Court on

September 23, 1988, defendants move this Court to enter

judgment in accordance with the defendants’ motion for

directed verdict for inequitable conduct as to the Becker ‘733

patent, based on the trial evidence. The defense of inequitable

conduct is an equitable defense to be evaluated solely by the

Court and is not a jury issue: Gardco Mfe. v. Herst Lighting

Co. 820 F. 2d 1209. 1211-1213. 2 USPQ 2d 2015, 2017-2019

(Fed. Cir. 1987). Under this ruling. a patent(s) may be valid

and yet unenforceable as to all of the claims of the patent

claims for inequitable conduct and. therefore. may be diposi-

tive of the merits of the Becker patent. which issue is distinct

from the issues of validity and infringement.

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No evidence was submitted by the plaintiffs to negate or

rebut the defendants’ inequitable conduct evidence and the

patentee’s testimony of his knowledge of material, undis-

closed prior knowledge and prior art, and his review of all of

the papers filed in the Patent office by his counsel fortifies

the defendants’ evidence of inequitable conduct before the

Patent Office and the attempt to improperly enforce the

invalid and/or unenforceable patent in this Court.

The patentee’s first act of serious misconduct was to file

his marked-up patent application which was altered and

amended after execution of the declaration for the applica-

tion. The materiality of the alterations and amendments in

the filed application are revealed by comparing the unmarked

copy of the Becker application, Exhibit 219, with the altered

filed copy of the patent application in Exhibit 140.

In addition, Becker's trial testimony and his publications

(i.e., Exhibit 223, pages 678, column 1, second paragraph)

identify the simple change to be made to the Heyer-Schulte

type inflatable breast implant that was never disclosed in

such simple terms in either his patent application or the

record before the patent office.

The patentee and his attorney, despite acknowledging

certain prior art, sought patent claims identical to the known

prior art (Radovan patent) and obtained patent claims de-

scriptive of the known prior art of record in the Becker patent

application (namely the Hever-Schulte and Dow Corning

implants of record in Exhibit 140) and accompanied by

misleading arguments in the Patent Office as to the problems

of the prior art structures. contrary to the knowledge of the

prior art of Mentor and the patentee.

The claims allowed by the patent examiner were erro-

neously granted over the teachings in the Radovan patent

alone without consideration by either the patent examiner or

Becker's patent counsel of the prior art of record in the Becker

application, as well as other prior art known to Becker at the

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time. Becker knew, or should have known, that the changes

adopted to distinguish over the Radovan prior art of record

were insufficient for defining patentable subject matter.

A large volume of prior art is found in Mentor’s represen-

tations to the Federal Drug Administration (FDA), per Ex-

hibit 276. as to prior art and equivalency, which is totally

absent from the record in the Becker file wrapper and, there-

fore, was not considered by the patent examiner.

There can be no issue as to the materiality of the wealth

of uncited, known prior art and of the gross negligence of

Becker, his patent counsel and Mentor, in not making this

prior art of record for evaluation by the patent examiner.

New Trial

In the alternative. defendants move the Court to set aside

the verdict and the judgment entered thereon and grant the

defendants a new tria! on the following grounds:

1. The verdict is contrary to law and the Court's instruc-

tions thereon as to damages.

2. The verdict as to validity and infringement of the

patents is contrary to the weight of the evidence, as noted

hereinabove.

3. The verdict of the jury as to damages is grossly

excessive and unreasonable under the evidence and contrary

to law and was determined under the influence of passion or

prejudice.

4. The verdict of the jury as to willful infringement ts

contrary to law as there is no evidence of copying either

product. The defendants’ flat tissue expanders are completely

structurally distinct from the patented product and nonin-

fringing. The defendants’ original mammary prosthesis was

developed based on defendants’ own products and¢ the state

of the art long before the grant of the Becker patent in

February. 1987.

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5. The sums awarded in the jury verdict are essentially

sums for lost profits offered by Mentor and include sums for

prejudgment interest. The inclusion of prejudgment interest

in the damage award is erroneous as the award of prejudgment

interest is solely within the discretion of the Court and not

the jury. The inclusion of these sums is excessive and

erroneous.

6. The award of lost profits is contrary to law [Paper

Converting Machine Co. v. Magna Graphics Corp. 745 F.2d

11,21, 223 USPQ 591. 598] (Fed. Cir. 1984) since the evi-

dence of both parties establishes that the market for the tissue

expanders and mammary prosthesis was not a two-supplier

market and the evidence does not establish, according to law,

that the plaintiff would have made the sales made by Cox-

Uphoff. The evidence also establishes the availability of a

number of acceptable noninfringing substitutes for each of

the products alleged to infringe to negate the award of dam-

ages based on lost profits as a whole.

7. The correct measure of damages. if any. should be

based on a “reasonable royalty” under the law: 35 U.S.C.

284.

!

8. Damages are governed by 35 U.S.C. 284. The limita-

tions on damages are governed by 35 U.S.C. 287. The jury

award is clearly excessive since it ignores the fact that no

evidence was presented to establish when Mentor’s products

were marked with the patert notice (or if the Mentor products

are covered by the patent in suit) and no notice of infringe-

ment was received by the defendants of the Radovan et al

patent prior to January. 1987. therefore, damages should not

have been awarded prior to that time. The damage award

further included an award of lost profits for the year 1985, at

a time the defendants had not produced or sold an allegedly

infringing tissue expander product. Similarly, the first notice

of infringement of the Becker patent grant that Mentor

provided the defendants was May. 1987. and the jury erro-

A-64 .

neously awarded damages commencing February 18, 1987,

again, contrary to law.

9. The Mentor computation of damages is not sufh-

ciently detailed to permit a determination of their correctness

and are based on unwarranted assumptions, contrary to law

and/or incomplete evidence.

10. In the event the defendants’ motion not withstand-

ing the verdict is denied. consideration by the Court of the

plaintiffs’ remitting a portion of the damages verdict deemed

excessive 1s also requested.

11. The closing argument by plaintiffs’ counsel entitled

defendant to a new trial for the following reasons:

(a) The plaintiffs’ counsel’s demonstrations of how the

defendant’s tissue expanders function by squeezing one of

them in front of the jury was improper and misled the jury

as to how the tissue expander functions.

(b) The directions of the plaintiffs counsel to the jury

to examine an unidentified clinical text and the claim books,

Exhibits 127 and 128, to establish infringement of three

different products was erroneous, misleading and prejudicial

since the claim books are vague and indefinite in merely

directing attention to a part of defendant’s products and

concluding that the part numbered necessarily produces the

function recited in the patent claim; i.e., in Exhibit 127 the

counsel’s conclusion as to the recited function of the base (3)

in the exhibit is erroneous and prejudicial.

Exhibit 128 is apparently directed only to the new design

of the defendant's mammary prosthesis. Exhibit 312A-C,

which is significantly different in design from the design of

the prior mammary prosthesis. Exhibit 310.

(c) The new mammary prosthesis (Exhibits 312A-C)

was produced after the litigation commenced in an attempt

to properly design around the Becker patent claims. The

Exhibit erroneously and prejudicially equates the two prod-

A-65

ucts, including for purposes of willful infringement. whereby

the jury was completely misled as to the construction and

operation of the defendant's products and their relationship

to the patent claims in issue.

(d) The claim book, Exhibit 128, is contrary to the

evidence, including the testimony of the plaintiffs’ patent law

expert (which was also erroneous).

12. The plaintiffs’ counsel’s comments to the jury re-

garding the prior art were erroneous and prejudicial, and the

comments were not relevant in stating and inferring that

(a) the device in the Berson patent 4,246,893 (not of

record), Exhibit 257, was for use in the stomach and was not

a breast implant and therefore was not the same thing;

(b) Dr. Becker considered the Birnbaum-Olson perma-

nent expander, Exhibit 318, to be the same or the equivalent

of the cited Lake patent 4.095,295, Exhibit 295, and therefore

he need not tell the Patent Office about Birnbaum, although

no evidence as to this position was ever filed in the Patent

and Trademark Office or at any time prior to Becker’s trial

testimony. This misled the jury as to its patent validity

determination as to the Becker patent and also should have

been considered by Becker and Mentor as inequitable con-

duct, thereby misleading the jury and prejudicing the defen-

dant; and

(c) the defendant's case should have included the testi-

mony of suregeons. knowing such evidence is not necessary

or necessarily competent.

13. This Honorable Court erred during the course of

the trial in the following respects:

(a) In permitting the plaintiffs’ patent law expert to

testify as a technical expert contrary to the law and his

qualififications, thereby misleading the jury and prejudicing

the defendant.

A-66

(b) In permitting Dr. Becker to testify as a technical

expert contrary to his qualifications. thereby misleading the

jury to the defendant's prejudice.

Respectfully submitted,

EDWARD J. DaRIN, INC.

Date: Oct. 5, 1988 By EpwarRD J. DaRIN

Edward J. DaRin

Attorney for Defendants

A-67

CERTIFICATE OF SERVICE

I hereby certify that a true and correct copy of MOTION

FOR JUDGMENT NOT WITHSTANDING THE VER-

DICT AND ALTERNATIVE MOTION FOR NEW TRIAL

BY DEFENDANTS PER F.R.CIV.P. 50(b) of Defendant

Cox-Uphoff was hand delivered by messenger. to counsel for

Plaintiffs at the address indicated below on this 5th day of

October 1988:

Michael R. Sullivan, Esq.

Sullivan, Walsh, Rossbacher & Wood

Biltmore Tower, 18th Floor

500 South Grand Avenue

Los Angeles, CA 90071

EDWARD J. DARIN

Edward J. DaRin

A-68

EDWARD J. DaRIN

EDWARD J. DaRIN. INC.

Suite 518

301 E. Colorado Blvd.

Pasadena, CA 9110i

(818) 793-0689

Attorney for Defendant

IN THE UNITED StaTEs District COURT

CENTRAL DISTRICT OF CALIFORNIA

| Civil Action No. 87-5611 JWC (Tx)

DEFENDANT’S MOTION TO

MENTOR CORPORATION. ¢7/ al. AMEND THE FINDINGS

Plaintiffs. OF FACT, CONCLUSIONS

rs. i‘ OF LAW. AND JUDGMENT

- AND FOR ATTORNEY’S

Cox-UPHOFF CORPORATION, FFES: MEMORANDUM OF

Defendant. POINTS AND AUTHORITIES

Hearing Date: April 10, 1989

Time : 10:00 A.M.

The defendant, Cox-Uphoff Corporation, moves this

Court foran ORDER amending the Findings of Fact, Conclu-

sions of Law and Judgment entered in this action on February

28, 1989, and for an award of attorney’s fees in the defendant’s

favor.

The requested ORDER includes an ORDER finally dis-

posing of the issue of inequitable conduct before the Patent

and Trademark Office relative to the Becker patent 4.643,733

pursuant to Federal Rule of Civil Procedure 49(a). The issue

of inequitable conduct was tried. but no jury verdict was

A-69

rendered thereon and. therefore. the jury right has been

waived and is now ripe for decision pursuant to Rule 49(a).

The Motion comprehends a request for amending the

Findings of Fact. Conclusions of Law and Judgment in

accordance with any additional finding and Conclusions of

Law pursuant to Federal Rules of Civil Procedure 52(b) and

59(e). The requested additional findings are directed to the

factual basis establishing that this litigation is “exceptional”

within the meaning of 35 USC 285 required for an award of

attorney’s fees pursuant to said patent statute governing an

award of attorney’s fees in patent litigation. The Motion is

directed to the infringement claim made on the basis of the

Radovan et al U.S. patent 4.217.889 and the Becker patent

4,643,733 individually and collectively. It is clear that a

finding or conclusion that the Becker patent was obtained by

inequitable conduct entitles the defendant to its attorney’s

fees for defending against the Becker patent.

The Motion is also directed to correcting the Judgment

as to the invalidity of the Radovan et al patent so as to

conform it to the Court’s Conclusions of Law in 99(a) and

4]3 of the Judgment. Also a conclusion of inequitable conduct

as to the Becker patent would render each and every patent

claim thereof unenforceable.

WHEREFORE the defendant moves for an ORDER

establishing that the Becker patent in suit was obtained by

inequitable conduct before the Patent and Trademark Office

accompanied with additional Findings of Fact and Conclu-

sion of Law establishing the “exceptional” nature of this

litigation and an award of attorney’s fees pursuant to 35 USC

285 and the amendment of the Judgment as requested and

in conformance with any additional findings and/or Conclu-

sions of Law. In the event of an award of attorney’s fees in

favor of the defendant. it is requested that this Court reserve

jurisdiction of the litigation to permit the defendant to pro-

duce the required documentation for establishing the mone-

A-70

tary amounts of attorney's fees and expenses for the purposes

of the award.

The present Motion is based on the aforementioned

Federal Rules, 35 USC 285 and the attached Memorandum

of Points and Authorities.

MEMORANDUM OF POINTS AND AUTHORITIES

Introduction

Certain Findings of Fact and Conclusions of Law were

entered in this litigation. along with a Judgment, on February

28, 1989. This Court has ruled that the Radovan et al U.S.

patent 4,217,889 is not invalid but is not infringed by the

Versafil devices manufactured and sold by the defendant, the

Cox-Uphoff Corporation, and that the Becker U.S. patent

4,643,733 was invalid and unenforceable. The Court rulings

resulted from the granting of the defendant’s Motion for

Judgment N.O.V. relative to the jury verdict on patent valid-

ity and infringement.

One of the issues tried to the jury is whether the Becker

‘733 patent was obtained as a result of inequitable conduct

before the Patent and Trademark Office. No verdict was

returned by the jury on the inequitable conduct facts pre-

sented to them as no interrogatory was presented to them on

this issue. The Court’s Findings of Fact include facts which

form a basis for a claim of inequitable conduct, if not a

Conclusion of Law. on behalf of the defendant.

The issue of inequitable conduct has been ruled on by

the Court of Appeals for the Federal Circuit as an equitable

issue and may be evaluated solely by a court pursuant to the

Federal Circuit’s decision in Gardco Mfg. v. Herst Lighting

Company 820 F.2d 1209. 1211. 1213, 2 USPQ 2d 2015,

2017-2019 (Fed. Cir. 1987). This position has been reaffirmed

by the Federal Circuit in its recent decision of Kingsdown

A-7i

Medical vy. Hollister, Inc. 9 USPQ 2d 1384 (no Fed. cite) (Fed.

Cir. Dec. 21, 1988). In the Kingsdown Medical decision, the

Federal Circuit in an in banc decision clarified the law of

inequitable conduct and specifically the intent element of

inequitable conduct that should be controlling. Plaintiffs,

Mentor, had requested the jury trial, including on this unre-

solved issue, and it now appears that is has waived its right

for a jury verdict on inequitable conduct. No positive

ruling resolving the inequitable conduct issue has been made,

although the defendant moved the Court at the trial to enter

such a Judgment in accordance with its Motion for directed

verdict as to the Becker ’733 patent. Federal Rule of Civil

Procedure 49(a) authorizes the Court to make a finding on

this issue that is now considered to have been waived as a

jury issue. Plaintiffs have appealed and will re-appeal, making

it important that the Court rule on this issue at the present

time. .

In addition, as a result of this Court’s detailed entry of

Findings of Fact and Conclusions of Law, issues that are

within this Court’s discretion as to whether the defendant 1s

entitled to its attorney's fees as the prevailing party pursuant

to 35 USC 285. is now timely.’

The defendant submits that the facts required for resolv-

ing these issues are not in dispute. i.e.. Becker’s admissions

(as noted in the Court's findings). but merely require the

application of the law to the undisputed facts at this time.

Amendment of Findings of Fact and Conclusions of Law

The defendant submits that the request for additional

Findings of Fact and Conclusions of Law and the amendment

of the Judgment may be made pursuant to Federal Rules of

Civil Procedure 52(b) and 59(e) and are proper in this case,

' In the defendant's submission of Proposed Findings of Fact and

Conclusions of Law. this Court has eliminated the proposed Facts

and/or Conclusions with respect to inequitable conduct and

attorney's fees.

A-72

since they are merely amplifications of certain Findings of

Fact previously made by this Court. and the requested amend-

ments are not in conflict with them and have no reference to

the facts found by the jury as they are matters solely within

this Court’s discretion and judgment; Kardon y. National

Gypsum Company 83 F. Supp. 613 (D.C. Pa. 1947); Kennedy

v. U.S. 115 F.2d 624 (CA-9, 1940).

Request for Additional Findings, Conclusion and Judgment

A. Radovan U:S. Patent 4.217,889 (’889)

The Findings of Fact and Conclusions of Law entered

by this Court form a basis for additional findings as to

the ‘889 patent relative to the improper prosection of the

infringement action based on this patent leading to a conclu-

sion that this portion of the litigation is exceptional within

the meaning of 35 USC 285 and an award of attorney’s fees

in favor of the defendant should be made, along with the

corresponding amendments to the Judgment.

B. Becker U.S. Patent 4.643.733 (’733)

The Findings of Fact and Conclusions of Law with

respect to Becker as to the validity of the patent show that

the necessary investigation and due care required of a patent

owner with regard to the validity of the patent was not entered

into aS certain admissions made by the patentee, Becker,

formed the basis for the Court’s invalidity and unenforceabil-

ity decision and would render the case exceptional within the

meaning of 35 USC 285 requiring an evaluation of the award

of attorney’s fees. In addition. the facts presented at trial

with respect to the inequitable conduct are ripe for decision.

Mentor’s Infringement Claim as to the ‘889 Patent is

“Exceptional”

The enforcement of the Radovan et al ’889 patent in this

case is “exceptional” within the meaning of 35 USC 285

based on this Court's present Findings of Fact as to the issues

A-73

of infringement of the Radovan et al patent claims, namely,

Findings Nos. 48 through 50. Finding No. 48 includes the

recitation that “it is incredible that a patent owner could

assert infringement of patent claims without revealing the

application of the patent claims to a defendant’s accused

structures, long after commencing the litigation”. In addition,

Finding No. 50 establishes that Mentor did not provide any

proof concerning their theory of infringement.

In addition to the aforementioned Findings of Fact, this

Court’s Conclusion of Law No. 15 further established that

“Mentor presented no proofs of infringement of a properly

interpreted patent claim”. The Fonar citation in Conclusion

of Law No. 15 clearly establishes that without a proper

interpretation of the patent claims, no proof of infringement

has been validly presented, and with no proper proofs, there

has been a complete failure of the plaintiffs to meet their

burden of proof on infringement and this matter should have

been appreciated or known by the plaintiffs long prior to the

trial. This is also supported by the Court’s Finding No. 24

which essentially establishes the prosecution history estoppel

governing the proper interpretation of the claims.

It should also not go unnoticed that the plaintiffs pre-

sented no rebuttal to the defendant’s position on non-infringe-

ment and file wrapper estoppel at the trial and merely relied

on their patent law expert’s testimony based on an assumption

of validity of the Radovan et al patent, as is evidenced by

the Court’s Conclusion of Law No. 15.

What is incredible is Mr. O’Neill’s rebuttal closing argu-

ment on the last day of the trial. Mr. O’Neill made certain

admissions to the Court concerning his agreement with the

defendant’s position that the Radovan et al patent claims

require the tissue expander to have a substantially non-

distensible base. He also agreed that there was prosecution

history estoppel on this point, again agreeing with the Cox-

Uphoff defense. The Mentor patent law expert saw it differ-

ently. Cox-Uphoffs witnesses established the fact that the

A-74

“Versafil” tissue expander had a distensible, non-shape re-

taining base. The Court’s conclusions on infringement are

supported by Mr. O’Neill’s admissions. .

Mr. O'Neill asked the jury to prove his case and experi-

ment with the exhibits. Was this not an admission of

the failure to meet the Mentor burden of proof on the

infringement of Radovan et al? The answer is obviously,

“Te.

Mr. O’Neill’s remarks included the question to the jury,

“Why are we here?” (page 142, line 13, of the attached trial

transcript). Now that the jury has been dismissed, we all

know why we were there—Mentor’s management wanted to

make an example of little Cox-Uphoff Corporation to the

industry. That was obviously the motive for Mentor’s actions

since the rushing through of the litigation did not take into

consideration the required, detailed analysis of the infringe-

ment claims.

Counsel! for defendant now asks, “Why did not Mentor

admit. what Mr. O'Neill now admits, long before the trial?”

The reason Cox-Uphoff was in trial should now be evident

to all. Again, Mentor refused to accept the position that Mr.

O'Neill admitted to at the end of the trial. Should Cox-

Uphoff bear the expense of going through trial when they

were right on their position prior thereto and Mentor refused

to concede? The defendant submits that Mentor should be

assessed the defendant's attorney's fees. Copies of certain

pages from the trial transcript are attached hereto.

The aim of the Statute. 35 USC 285, with respect to

awarding a prevailing accused infringer his attorney's fees is

to “prevent a gross injustice”: Rev/on v. Carson Products Co.

803 F.2d 676. 679. 231 USPQ 472, 473-474 (Fed. Cir.

1986). Prevailing accused infringers have been awarded

their attorney's fees when there has been an inadequate

consideration of the infringement claim prior to trial and

during the trial. Scientifically informed persons could not

A-75

differ on the actual physical characteristics and functions of

the “Versafil” expander. In this case no technical expert

appeared on behalf of the plaintiffs. The Federal Circuit has

so indicated in Machinery Corp. of America vy. Gullfiber A.B.

774 F.2d 467, 473, 227 USPQ 368, 372 (Fed. Cir. 1985).

Defendant submits that the plaintiffs could not in good

faith believe that the anes ly device infringed when

properly interpreted patent claims are evaluated. Although

the presumption of validity pursuant to 35 USC 282 attaches

to a patent when granted. no similar presumption attaches to

an allegation of infringement. and an accuser infringer cannot

hide behind the cloak of a presumption solely involving

infringement: see page 372 of 227 USPQ of Machinery Corp.,

Supra, citing Kaehni v. Diffraction Co., Inc. 342 F. Supp. 523,

535, 173 USPQ 705. 714 (D. Md. 1972): affd.mem.. 473

F.2d 908, 178 USPQ 321 (4th Cir.): cert. den. 414 U.S. 854

(1973). Under such circumstances courts have found that

the litigation is exceptional. and the caption to this Court’s

Finding of Fact. “Caption C”. on page 17, would readily lead

to such a conclusion. along with the aforementioned Findings

and Conclusion of Law, that this case 1s, in fact, exceptional;

and the Court is respectfully requested to now make such a

finding, along with a Conclusion of Law that the defendant

is entitled to its attorney's fees with respect to the unnecessary

defense to the claim of infringement based on the Radovan

et al patent to prevent a gross injustice to the defendant Cox-

Uphoff Corporation. It should not be overlooked that the

cost of patent litigation these days is very high. Accordingly,

an improperly brought infringement claim made against a

small company (such as the defendant) may be a commercial

weapon that cannot be fought back. Since the law requires

that the Court make a specific finding of the exceptional

circumstances as a prerequisite to awarding attorney's fees

under 35 USC 285. such a request is deemed in order in this

case and consistent with the Court’s prior Findings and

A-76

Conclusions of Law: Srevenson vy. Sears, Roebuck & Co. 713

F.2d 705, 712-713. 218 USPQ 969, 975 (Fed. Cir. 1983).

Similarly, defendant requests that with the entered find-

ing of exceptional circumstances that a Conclusion of Law

be added by the Court indicating that the defendant is entitled

to its attorney’s fees for defending against the claim of

infringement of the Radovan et al ’889 patent.

The Assertion of the Becker Patent 4,643,733 is “Exceptional”

The defendant submits that this litigation is exceptional

with respect to the Becker patent within the meaning of 35

USC 285 on at least three different grounds, taken individu-

ally and/or collectively. These grounds include (1) the

inequitable conduct of the applicant Becker in procuring his

patent from the U.S. Patent and Trademark Office, (2) the

invalidity under 35 USC 102, based on Dr. Becker’s own

publication admitting prior use more than one year before

the filing date of the Becker patent application, and (3) the

invalidity under 35 USC 103. based on Dr. Becker’s own

publications, not disclosed to the Patent Office, which estab-

lished the simple substitution of a known prior art device

into the basic admittedly known implant to achieve “delayed

filling”.

Defendant submits that although the Court did not

enter any Findings of Fact and Conclusions of Law on the

infringement issues relative to the Becker patent, obviously,

in view of the invalidity of the asserted patent claims, never-

theless, it should be noted that the plaintiffs resorted to the

same type of erroneous infringement analysis through their

patent law expert witness that they put forth with regard to

the Radovan et al patent. The requirement for defending

against the infringement claim should also be considered in

the overall view of the exceptional nature of the plaintiff's

litigation. It will be recalled that two distinctly different

designs of the defendant’s “RDL-Xpand”™ (reverse double

lumen) mammary implant were charged to infringe. Plain-

A-77

tiffs’ patent law expert attempted to equate the two designs

on a broad basis for infringement purposes without reference

to the prior Heyer-Schulte inflatable implant.

Inequitable Conduct—Becker

Defendant submits that the Findings of Fact established

by this Court support the defendant’s claim that the Becker

patent was obtained by inequitable conduct. The elements

for evaluating inequitable conduct before the Patent and

Trademark Office has been established by the decision of the

Court of Appeals for the Federal Circuit in J. P. Stevens &

Co. v. LexTex, Ltd. 747 F.2d 1553, 1559, 223 USPQ 1089,

1092 (Fed. Cir. 1984). The J. P. Stevens tests were refined

in A. B. Dick Company vy. Burroughs Corp. 798 F.2d 1392,

230 USPQ 853. 854 (Fed. Cir. 1986). The J. P. Stevens

decision sets out the starting point is the Patent Office Rule

of Practice 1.56. 37 C.F.R. 1.56. and that the materiality of

omitted or false information and intent of the actor must

be balanced and considered with different weights given,

depending on the materiality of withheld information or

erroneous information submitted to the Patent Office. The

matter of intent, only. was recently clarified by an in banc

decision of the Federal Circuit in Kingsdown Medical v.

Hollister, inc. 9 USPQ 2d 1384 (Fed. Circ. Dec. 21, 1988),

Supra. This Federal Circuit decision indicates that the

element of intent must be evaluated from the standpoint that

the involved conduct must be viewed in light of all the

evidence to require a finding of intent to deceive. This, of

course, is in respect to the basic elements defined in the J. P.

Stevens, Supra. decision concerning materiality and intent

and the balancing required in coming to a conclusion, as a

matter of law. The Federal Circuit has recognized that the

required balancing requires judicial discretion be brought to

bear and the District Court judge should decide it and not a

jury; American Hoist & Derrick Co. v. Sowa & Sons, Inc. 725

F.2d 1350. 1364. 220 USPQ 763. 774 (Fed. Cir. 1984).

A-78

Defendant submits that Findings of Facts Nos. 52, 53,

54, 56. 57, 59, 60. 62, 65. 66. 67. 68, 69 and 73 establish

the exceptional circumstances with respect to Dr. Becker’s

conduct before the Patent Office. leading to a legal conclusion

that he obtained his patent on the basis of inequitable

conduct.

A. Application Changed After Execution

Unlike the usual situation. the starting point in this case

is a portion of Patent Office Rule of Practice 37 C.F.R. 1.56

that relates to the patent application and declaration as filed

in the Patent Office by Dr. Becker. The Becker patent

application as filed in the Patent Office on April 4, 1983, was

marked up, altered and amended after execution of the

declaration, contrary to 37 C.F.R. 1.56(c)(4): see Finding No.

52. This Finding establishes the significance of Becker's

alterations to his patent application after execution of the

declaration and as filed in the Patent Office. The plaintiffs,

including Dr. Becker. have continuously insisted that the

“delayed filling” implant developed by Dr. Becker was a

substantial advance in the art. all while recognizing that Dr.

Radovan had disclosed this “delayed filling” feature prior to

Becker; see Findings Nos. 52 and 54. In addition, it will be

noted that the term “subcutaneous expander” was utilized in

the publications of Dr. Radovan et al and in the Heyer-

Schulte publications known to Dr. Becker. Nevertheless, in

originally claiming the alleged Becker improvement over the

prior art, Becker’s counsel was not successful since all of the

original patent application claims were identically descriptive

of the device disclosed in the Radovan ’889 patent and the

Radovan publications; see Finding of Fact No. 57. Accord-

ingly, despite the admissions of Dr. Becker concerning Dr.

Radovan et al’s prior work and the Heyer-Schulte prior work,

he claimed the Radovan et al invention when he submitted

his altered application to the Patent and Trademark Office

in order to bring out. among other things, “delayed filling”.

A-79

The defendant submits that this is one factor in evaluat-

ing the Becker conduct before the Patent Office and should

be placed on the pans of the balance for legally evaluating

Dr. Becker’s conduct before the Patent Office. The alterations

per se are considered serious acts of misconduct by the Patent

and Trademark Office and have been considered so for quite

a few years, as evidenced by the decision of the Commissioner

of Patents in 1959 in Wainer v. Ervin 122 USPQ 608; also

note Manual of Patent Examining Procedure. 5th ed. rev.

May. 1988, 92005. pages 2000-10 through 2000-12.

B. Failure to Disclose Material Information

The other aspect of Patent Office Rule 1.56 is the “duty”

of applicant and his counsel to disclose material information

to the patent examiner. as represented in the Courts Findings

Nos. 53 and 54. It is seen that Dr. Becker was fully advised

by his counsel concerning his duty and that certain disclosures

as to material information was made to the Patent Office as

represented in Finding No. 54: i.e., page 21, lines 9-13 of

Finding No. 54. Dr. Becker. however, did not disclose all

the material information of which he was aware at the time

of filing his patent application and on or about that time.

These material publications included admissions by Dr.

Becker as to what he. in fact. had done and which was

confirmed by him at the trial. These undisclosed, material

references are set out in this Court’s Finding of Fact No. 65,

along with Dr. Becker’s admissions. In addition to his own

publications, the exclusive licensee, Mentor, made certain

representations concerning material prior art to the Federal

Drug Administration with respect to the prior activities of

others, as evidenced by this Court’s Findings Nos. 66 and

67. This Court's Finding No. 68 establishes Dr. Becker’s

knowledge of the Birnbaum/Olsen publication identified in

Finding No. 67 and the reasons that it was not submitted to

the patent examiner by Dr. Becker. The Birmbaum/Olsen

publication was directly contrary to the Declaration of one

Dr. Caffee filed in the Patent Office on behalf of Dr. Becker,

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as indicated in Finding No. 79. This publication is material

since it also describes the use of a single implant that is

periodically expanded and left in the body permanently after

expansion.

The materiality of this undisclosed information is clear,

including the fact that a reasonable examiner would have

considered this undisclosed information important in deter-

mining to grant a patent. Focusing on this alone, the Exam-

iner would have undoubtedly refused to allow the Becker

patent application claims.

If we assume that Dr. Becker’s analysis of the Lake patent

as evidenced by Finding No. 68, that it discloses a single

implant that functioned as a tissue expander and a permanent

implant, then the submission of Dr. Caffee’s Declaration,

Finding No. 60. by Becker was unnecessary and mislead the

patent examiner as to the prior art.

Another fact to be considered is represented by Finding

No. 69 that Dr. Becker was not candid with the patent

examiner concerning the leakage problem of a single lumen

implant of which he was personally aware and which was

well known in the industry at the time. Dr. Becker did not

disclose that the solution to the leakage problem could be

through the use of a different construction. as discussed with

Cox-Uphoff’s president and evidenced by the Court’s Finding

No. 70. These matters are all. beyond question. material

information that the examiner should have considered prior

to allowing the Becker patent application.

Furthermore. the patent examiner did not have Dr.

Becker’s publications. including Dr. Becker’s admissions,

before him wherein Dr. Becker admitted that he made a

simple substitution of prior art devices and is in Finding No.

65. In view of the examiner's initial examination of and

position on Dr. Becker's patent application claims, if the

examiner had Becker's admissions before him. it would have

clearly established that the examiner's initial rejection was

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correct and the application would not have issued as a patent.

This is comprehended by the Court’s Finding No. 58. In any

event, the admissions made by Dr. Becker in his publications

were not before the Patent Office and also should have led

him to understand that the allowed, amended claims did not

distinguish over the prior art and which amended claims

appear in the patent in suit and have been asserted against

the defendant.

The only basis for distinguishing over the Radovan et al

‘889 patent related to the characteristic of the prosthesis

described in the claims which were obviously true of the prior

art Heyer-Schulte implant so that Dr. Becker should have

known that the amendatory material was not original with

him and could not distinguish over known prior art, as

evidenced by Findings Nos. 71 and 72.

Defendant submits the above clearly establishes the with-

holding of materia/ information that should have been evalu-

ated by the examiner, as a whole, prior to completing his

examination. It was also clear that the examiner would have

rejected the Becker application had he had all the undisclosed

information before him.

There can be no issue that Dr. Becker’s admissions are

material to the examination of his patent application. A

determination of inequitable conduct will not be avoided if

knowledge of materiality or gross negligence greatly outweighs

the lack of deceptive intent. as the facts establish herein; A.

B. Dick Co. v. Burroughs Corp. 798 F.2d 1392. 1398, 230

USPQ 849, 854 (Fed. Cir. 1986). Supra.

As to completing the analysis on intent. the failure of

Dr. Becker to disclose material information establishes that

he was grossly negligent. if not intentionally deceitful. as a

natural consequence of his non-disclosures.

The defendant submits that the materiality of the undis-

closed information weighs most heavily in balancing Dr.

Becker’s conduct before the PTO. particularly in view of the

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wealth of undisclosed information. including the disclosures

to the Federal Drug Administration. In balance, the facts

should cause the Court to conclude that the Becker patent

was procured by inequitable conduct.

Prior Use—35 USC 102

This Court has concluded that Dr. Becker's publication

in April, 1984, Exhibit 223. establishes Becker’s admission

of a public use of the Becker claimed device more than one

year before the filing date of the Becker patent application;

see Conclusion of Law No. 21. This Conclusion of Law is

based on the Court's Finding No. 80.

The Court’s attention is also directed to Mentor’s An-

swers to the Defendants’ Interrogatories and Requests for

Production of Documents which bear on the issue of prior

sale and Dr. Becker's publication that is recited in Finding

No. 80. Inthe Plaintiffs’ Answer to Defendants’ Interrogatory

No. 6 (Exhibit 271) and the Supplemental Answer thereto,

Exhibit 270, references are made to Becker’s April 19, 1984,

publication and references the updating of the publication by

Dr. Becker. Yet. in responding to the Request for Documents,

Exhibit 272, Requests 2, 3 and 4. evidence Mentor’s lack of

production of documents relating to conception, reduction

to practice, of both patents in suit or documents supporting

the first public use or first offer for sale or first publication.

No document was ever produced at any time to support the

allegations of the Answer to Interrogatory No. 6 that the

publication was updated. or that would contradict the clear

import of the statements made in Dr. Becker’s own publica-

tion referenced in the Answer. Accordingly, no proofs were

established that the date of first use was other than indicated

by Dr. Becker in his own publication, and this admission of

prior use establishes the invalidity of the Becker patent claims

under 35 USC 102(b) beyond doubt.

In a factual situation that is on “all fours” with respect

to the facts of this case. the Federal Circuit has affirmed a

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conclusion of a prior sale (identical to prior use) under 35

USC 102 based on an admission by the patent owner and the

fact that the patent owner brought suit on the patent despite

its knowledge of the prior sales: Jnterpart Corp. v. Imos Italia

777 F.2d 678, 686. 228 USPQ 124, 130 (Fed. Cir. 1985).

The Federal Circuit in /nterpart, Supra, also affirmed the

District Court’s conclusion that, on the basis of the admission

of such prior activities. the finding that the case was an

exceptional one for the purposes of attorney’s fees under 35

USC 285, was proper and is also proper in this litigation.

The defendant is entitled to an award of attorney’s fees on

this basis, as well. in this case.

Similarly, the issue of inequitable conduct, failure to

disclose a party’s own publications and commercial devices

re 35 USC 102 was treated in 4. B. Chance Co. v. RTE Corp.

854 F.2d 1307, 7 USPQ 2d 1881 (Fed. Cir. 1988).

Invalidity Under 35 USC 103

Along with the Court’s Findings discussed hereinabove,

a number of them also relate to what the defendant submits

was a Clear case of invalidity of the Becker patent claims

based on Dr. Becker’s pre-trial admissions and the submission

of claims that were identical to the disclosures in the admitted

prior art Radovan et al patent. These facts are evidenced by

Findings Nos. 57. 58, 62, 72, 73, 74, 76, 77, 79 and Conclusion

of Law 18. Defendant submits that for the purpose of an

“exceptional” case evaluation under 35 USC 285, these facts

should be evaluated, along with the fact that the plaintiffs

merely relied on the presumption of patent validity under 35

USC 282 and presented no rebuttal evidence concerning the

invalidity under 35 USC 103. The rejection by the patent

examiner of the patent application claims was based on 35

USC 102 which established the identity with the Radovan et

al patent disclosure; see Finding No. 61.

The defendant in relying on Finding No. 62 submits that

a good faith evaluation of the claimed subject matter in light

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of the record before the Patent Office, alone, should have

established to Mentor. prior to trial, the invalidity of the

Becker patent in suit.

It is very important to note for the purposes of this

Motion that the amendatory material included in Finding

No. 62 not only is descriptive of the prior art Heyer-Schulte

implant known to Becker (as well as other prior art implants

known to Becker)*, but also the fact that the “rigid base”

characterization of the Radovan et al patented tissue ex-

pander argued by Becker's counsel before the PTO, was not

Mentor’s position at the trial. Mentor, in attempting to

stretch the ‘889 patent claims, did not consider the claims

were restricted to a rigid base. If this position were correct

(which this Court found it was not), the amended Becker

patent application claims would be descriptive of the Rado-

van prior art under 35 USC 102 in the identical manner the

examiner found with respect to the original Becker patent

application claims. Stated differently, the amended and

unamended claims are identically descriptive of the prior art.

This erroneous position should have been known to Mentor

not only before the trial, but also before the charge of infringe-

ment made against the defendant and the commencement of

this litigation as these matters were all a part of the public

record.

Also, if it is considered the Radovan known prior art is

not restricted to a substantially rigid base portion, but is

flexible, the Radovan teachings were misrepresented to the

PTO and for that reason, as well, the Becker patent was

obtained by inequitable conduct.

The Court’s Finding No. 77 established the “lapse on

the part of the Examiner” in allowing the Becker patent

> The Radovan et al patent. acknowledged by Dr. Becker before

the Patent and Trademark Office to be prior art. also describes

the prior art tissue expander of Dr. Neumann which was a balloon

flexible in all directions: see column |. lines 43-55, of the ‘889

patent.

A-85

application claims. Apparently. there was a “lapse” on

the part of Dr. Becker in not recognizing that the simple

amendment to his patent application claims could not possi-

bly distinguish over the prior art in a patentable sense. The

law is clear that when a patent applicant commits fraud, or

was So grossly negligent as to support an inference of fraud

or inequitable conduct. “lapse” on the part of the examiner

does not excuse the applicant’s conduct; KangaROOS U.S.A.,

Inc. v. Caldor, Inc., 778 F.2d 1571, 1576, 228 USPQ 32, 35

(Fed. Cir. 1985). This establishes, as well, the “exceptional”

nature of this litigation.

In addition, with respect to Mentor’s knowledge of the

prior art as represented by the FDA submission, including

the Birnbaum/Olsen publication, it should have been readily

apparent to Mentor’s counsel and those skilled in the art that

the two-step procedure was not. in fact, novel and unique to

Dr. Becker and that the mere substitution of the prior art

reservoir or syringe for the prior art port of Radovan would

have been readily accomplished by anyone skilled in the art.

It was left to Cox-Uphoff to prove these facts at trial and to

establish the clear invalidity of the Becker patent in the

interest of the public.

The above comments apply to the prior art of record in

the Becker patent application; however, the uncited prior art

should also lead Mentor to conclude the Becker patent claims

were invalid — “obviously”. This Court’s Finding No. 78 with

respect to the uncited Berson patent 4,246,893 establishes the

minor difference between the Becker patent claims and the

prior art not uncovered by the patent examiner. The Radovan

et al prior teachings disclose the detachable fill tube at the

prosthesis which is not in the Berson ‘893 patent. Yet, this

prior art was ignored by Mentor in pushing forward with this

litigation.

Radovan-Becker Patents

The above analysis was applied to the Radovan et al and

the Becker patents individually. Defendant submits that the

A-86

Court should also consider the overall view of the patent

litigation based on these two patents and the conduct of

Mentor with respect to the pre-trial proceedings. the failure

to properly evaluate the infringement issues and the validity

of the Becker patent. as well as the detailed grounds submitted

hereinabove concerning each of these patents, so that the

Court can readily conclude that this is an “exceptional” case

and that attorney’s fees should be awarded.

In the event the Court agrees that attorney’s fees should

be awarded, an opportunity for the defendant’s counsel to

present the evidence to support the specific amounts with

regard to attorney's fees is respectfully requested, and it is

respectfully requested that this Court reserve jurisdiction of

this matter for that purpose.

AMENDMENT OF JUDGMENT AND FINDINGS

OF FACT

The Judgment as entered at the present time includes an

obvious error that renders it inconsistent with the Court’s

Conclusions of Law. Paragraph 9(a) should be amended to

conform with Paragraph 3, namely, that the ’889 patent is

not invalid.

Defendant also requests amendment of Finding of Fact

No. 57 so as to refer back to Finding No. 51 rather than

Finding No. 55.

The defendant is including under separate cover pro-

posed additional Findings of Fact and Conclusions of Law

for the Court’s consideration.

MOTION FOR NEW TRIAL—Rule 50(b)

The defendant previously moved for a judgment notwith-

standing the verdict. and in the alternative, for a new trial

pursuant to Federal Rule of Civil Procedure 50(b). This

Court granted the motion for J.N.O.V., but did not rule on

A-87

the motion for a new trial. The defendant now requests a

conditional ruling on the motion for a new trial for the

purposes of appeal be entered at the present time.

Defendant submits that the Court must pass on the

motion for new trial despite the fact that the motion for

J.N.O.V. has been granted: 5A Moore’s Federal Practice,

Paragraphs 50.13[1] and 50.14. pages 50-94 through 50-107,

including cases cited therein.

A-88

CONCLUSION

The defendant's Motion should be granted, the Findings

of Fact and Conclusions of Law and Judgment should be

amended, and the defendant should be awarded its attorney’s

fees to avoid a gross injustice. A conditional ruling granting

a new trial should be entered.

Kespectfully submitted,

EDWARD J. DaRIN, INC.

Date: 2/17/89 By EDWARD J. DaRIN

Edward J. DaRin

Attorney for Defendant

Cox-Uphoff Corporation

A-89

UNITED STATES DistrRICT COURT

CENTRAL DISTRICT OF CALIFORNIA

HONORABLE JESSE W. CURTIS, SENIOR DISTRICT

JUDGE PRESIDING

MENTOR CORPORATION, e7F ai/.,

Plaintiffs.

Vy. CV 87-5611-JWC (ER)

—

Cox-UPHOFF CORPORATION, @! al...

Defendants. |

REPORTER'S TRANSCRIPT OF PROCEEDINGS

LOS ANGELES, CALIFORNIA

THURSDAY, SEPTEMBER 22, 1988

SUSAN A. LEE. CSR 2800. CM. RPR

OFFICIAL COURT REPORTER

435 UNITED STATES COURTHOUSE

312 NORTH SPRING STREET

LOS ANGELES. CALIFORNIA 90012

(213) 626-6353

A-90

PATENT OFFICE.

THANK YOU.

MR. O’NEILL: MY TURN, JUDGE?

THE COURT: YOUR TURN FOR ABOUT 10

MINUTES.

MR. O’NEILL: 12 MINUTES?

THE COURT: 11.

COURTROOM: (LAUGHTER.)

REBUTTAL +

MR. O'NEILL: LET ME DEAL WITH RADOVAN

QUICKLY AND THIS_WHOLE ISSUE OF ESTOPPEL

AND DR. HARTLEY'S PATENT. AND ILL DO EX-

ACTLY WHAT I SAID COUPLE OF MINUTES AGO.

(REFERRING TO EXHIBIT.)

I AGREE WITH HIM (POINTS TO DEFENSE COUN-

SEL) THAT DR. RADOVAN’S PATENT REQUIRES

THAT THE BOTTOM BE SUBSTANTIALLY NONDIS-

TENSIBLE. I AGREE.

AND THE REASON IT REQUIRES THAT IT BE

SUBSTANTIALLY NONDISTENSIBLE IS BECAUSE OF

THE PROSECUTION HISTORY INTO THE PATENT

OFFICE AND DR. HARTLEY’S PATENT, WHICH MR.

FRINKS EXAMINED. AND THE PRIOR ART. I AGREE.

AND THE CLAIMS WERE LIMITED SO THAT THE

BOTTOM WOULD BE SUBSTANTIALLY NONDIS-

TENSIBLE: SUBSTANTIALLY NONDISTENSIBLE.

AND THE PATENT TEACHES DIFFERING DEGREES.

] AGREE WITH THEM.

THE QUESTION IS: IS THE BOTTOM OF THE

DEVICE SUBSTANTIALLY NONDISTENSIBLE? I

A-9]

AGREE WITH THEM ON THE LAW. I AGREE WITH

THEM ON THE PROSECUTION HISTORY.

GO BACK AND SEE IF YOU CAN DISTEND THE

BASE. AS HARD AS YOU CAN. SEE IF THE BASE WILL

DISTEND.

WHEN IT GOES IN THE BODY, THE BOTTOM

FLATTENS OUT. WHY DOES IT FLATTEN OUT? IT

FLATTENS OUT SO THAT THE FORCES ARE DISTRIB-

UTED AROUND THE BASE.

AND IF YOU FILL IT UP ALL THE WAY—SEE,

THEY DIDN’T FILL IT UP ALL THE WAY. WE’VE

BEEN THROUGH THAT. BUT. YOU KNOW, GO BACK

THERE AND TAKE THIS HUMMER (HOLDING SY-

RINGE) AND FILL THEM UP.

AND, YOU KNOW. DON’T ACCEPT THE LAW-

YER’S ARGUMENTS ON THE THING. FIGURE IT OUT

YOURSELF. WE’LL RISE OR FALL ON HOW YOU

FIGURE IT OUT.

BUT I AGREE WITH THEM: IT REQUIRES A SUB-

STANTIALLY NONSIMILAR BASE, AND HE TEACHES

IN THE PATENT DIFFERING DEGREES OF

DISTENSIBILITY.

I] COULD BREAK THIS THING AND GO TO JAIL

FOR BREAKING A COURT EXHIBIT. (SQUEEZING

EXHIBIT.)

I AGREE. OKAY? SO THAT’S IT. THE INFRINGE-

MENT OF THE RADOVAN PATENT IS A RELATIVELY

EASY ISSUE.

AND WE GOT THE ARGUMENT AGAIN ABOUT

THE INITIALING. WHEN I GOT ON THORNTON

AND—I SHOULDN'T SAY “WHEN I GOT ON.”

WHEN I WAS CROSS-EXAMINING MR. THORN-

TON. I SAID. “MR. THORNTON. IS THE FACT THAT

A-92

HE CHANGED IT MEANT—WERE YOU THE TELLING

THE JURY THAT THE PATENT’S INVALID?”

AND HE SAID. “NO, 1 WASN’T.”

WENT RIGHT AT IT. DIRECTLY. BUT THEY

BRING THE AGRUMENT UP AGAIN. IT’S

MUDSLINGING.

BERSON: HE SAYS. “TAKE A LOOK AT THE

BERSON PATENT.” HERE’S THE FIRST IMAGE OF

THE BERSON PATENT. OKAY?

THE PROSTHESIS IS IN THIS GOOD-LOOKING

GUY’S STOMACH. IT’S IN HIS STOMACH. IT ISN’T

USED FOR BREAST EXPANSION, IT ISN°T USED FOR

SKIN EXPANSION: IT’S IN HIS STOMACH.

WE JUST HEARD THAT DR. BECKER IN HIS

PATENT APPLICATION DID NOT CITE—AND HE

JUST SPECIFICALLY SAID, “HE DID NOT CITE A RE-

VERSE DOUBLE LUMEN TO THE PATENT

EXAMINER.”

THIS IS THE KONECKE PATENT: (DISPLAYS TO

JURY.) THE KONECKE PATENT IS A REVERSE

DOUBLE LUMEN. IT WAS CITED TO THE PATENT

EXAMINER.

THE RADOVAN PATENT WAS CITED TO THE

PATENT EXAMINER. THE HEYER-SCHULTE BREAST

IMPLANTS AND THE HEYER-SCHULTE SKIN EX-

PANDER WERE CITED TO THE PATENT EXAMINER.

THE PATENT EXAMINER HAD ALL OF THIS STUFF.

REVERSE DOUBLE LUMEN: THE REVERSE

DOUBLE LUMEN TECHNOLOGY, THIS KIND OF RE-

VERSE DOUBLE LUMEN IS BACK IN 1973, BEFORE

COX-UPHOFF WAS EVER BEGUN. COX-UPHOFF

DIDN'T INVENT REVERSE DOUBLE LUMEN TECH-

NOLOGY: ERNEST WILHELM KONECKE FROM WET-

A-93

TMAR, GERMANY. CAME UP WITH THE FIRST RE-

VERSE DOUBLE LUMEN PATENT. HERE IT IS. IT

WAS CITED TO THE EXAMINER.

NOW WE GET TO THE BIG SMEAR. YOU KNOW,

“MENTOR KNEW ABOUT ALL OF THIS TECHNOLOGY

IN THE 510(K) FILING, AND SO THEY SHOULD HAVE

GONE TO THE EXAMINER TO TELL THE EXAMINER

ABOUT EVERY SINGLE PATENT THAT THEY KNEW”?

MR. WESTMAN TESTIFIED AS TO WHAT THE OB-

LIGATION OF THE APPLICANT IS. THE APPLICANT'S

OBLIGATION IS NOT TO CITE EVERY BIT OF PRIOR

ART THAT HE KNOWS. THE APPLICANT'S OBLIGA-

TION IS TO GO TO THE EXAMINER AND CITE WHAT

IN HIS VIEW’S THE BEST, MOST PERTINENT ART;

THE BEST STUFF. SO THAT’S THE APPLICANT’S

OBLIGATION.

AND WHAT DID BECKER CITE TO THE EXAM-

INER? RADOVAN. A REVERSE DOUBLE LUMEN

PROSTHESIS: LAKE. WHICH IS THE SAME AS BIRN-

BAUM AND O: SON. HE CITED THE BEST STUFF.

AND THERE’S NO EVIDENCE THAT HE TRIED TO

HIDE ANYTHING OR TRICK ANYBODY.

THEN THERE’S THE ARGUMENT, “WELL, HE

DIDN’T TELL THE EXAMINER ABOUT LEAKY SALINE

LUMENS.”

THEY'VE MADE SALINE LUMENS FROM 1971 TO

THE PRESENT DAY. AND THEY’RE GOING TO GO

OUT WITH ONE NOW.

DOES THE PATENT COVER A DOUBLE LUMEN?

I'M NOT JUST RELYING ON THE PARAGRAPH IN

FRONT OF THE PATENT CLAIM. I'M RELYING ON

THE CLAIM ITSELF. WHAT DOES THE CLAIM SAY?

GO BACK THERE WITH THE CLAIM BOOK AND

APPLY THE CLAIM. AND THEN WANDER AROUND

A-94

THAT PATENT. LET ME GIVE YOU THE COLUMN

AND THE LINE NUMBER. COLUMN 6, LINE 11:

“IN ADDITION, THE DEVICE OF THIS INVEN-

TION IS USEFUL IN OTHER IMPLANTS WHERE”—

SHE THINKS | TALK TOO FAST (INDICATING

REPORTER)—"“WHERE DELAYED EXPANSION IS

DESIRABLE. AS IN MANY BREAST IMPLANTS, IT

MAY BE THAT THE IMPLANT SHOULD NOT BE

EXPANDED UNTIL THE WOUND HAS HAD A

CHANCE TO HEAL.”

HMM? AND HE CITED TO THE EXAMINER A

REVERSE DOUBLE LUMEN. AND THEY DRAFTED

THE CLAIM SO THE CLAIM WOULD COVER THE

INVENTION. :

THE CLAIMS COVER. BY THEIR WORDS: THE

DEVICES DO SUBSTANTIALLY THE SAME THING IN

SUBSTANTIALLY THE SAME WAY TO ACCOMPLISH

SUBSTANTIALLY THE SAME RESULTS AS THE TWO

PATENTS.

AND WE HAVE GOTTEN A TYPICAL COPIER’S

DEFENSE: “I DIDN’T HIT HER. BUT IF I DID, SHE

MADE ME DO IT. AND IN ANY CASE, SHE WASN’T

DAMAGED.”

WHO COPIED WHOSE HERE? I MEAN, WHY ARE

WE HERE? ARE WE HERE—ARE THEY SUING ANY-

BODY FOR INFRINGING THEIR PATENTS? WHO

COPIED WHAT?

THEY “DIDN'T HIT HER.”

THEY’VE GOT TO HAVE EVERY DEFENSE. IF

ANY ONE SINGLE DEFENSE WAS GOOD, THAT'S ALL

YOU'D HEAR ABOUT. BUT YOU THROW IT UP ON

THE WALL. CONFUSE THE JURY, AND SEE IF IT

STICKS. IT DOESN*T WORK. —oe

A-95

DR. BECKER’S A FINE MAN. DR. RADOVAN WAS

A FINE MAN: THEY HELPED PEOPLE. AND COX-

UPHOFF COPIED THE DEVICES.

THANK YOU. JUDGE.

FINAL INSTRUCTIONS +

THE COURT: LADIES AND GENTLEMEN, THE

VERDICT WHICH

THE COURT: YES.

MR. DaRIN: IT’S BEEN A WHILE SINCE I LOOKED

AT THESE SPECIAL INTERROGATORIES. I WAS

TRYING TO RECALL IF THERE WAS ONE THERE

WITH REGARD TO INEQUITABLE CONDUCT.

MR. O’NEILL: THERE IS ONE.

THE COURT: I THOUGHT THERE WAS.

MR. O’NEILL: THERE IS ONE.

MR. DaRIN: I JUST WANTED TO CHECK. THANK

YOU.

THE COURT: VERY WELL. COUNSEL WILL

LEAVE YOUR TELEPHONE NUMBERS WITH THE

CLERK SO WE CAN REACH YOU.

MR. O’NEILL: THANK YOU VERY MUCH, JUDGE.

IT WAS FUN.

THE COURT: WE’LL MISS YOU. HOWEVER, WE

MAY PROCEED FASTER’ WITH YOU IN

MINNEAPOLIS.

COURTROOM: (LAUGHTER.)

THE COURT: ALL RIGHT. GENTLEMEN. IT’S

BEEN AN INTERESTING CASE. I'VE ENJOYED LIS-

TENING TO BOTH OF YOU.

MR. DaRIN: THANK YOU. YOUR HONOR.

A-96

THE COURT: WE STAND ADJOURNED.

(PROCEEDINGS ADJOURNED TILL SEPTEMBER

23. 1988.)

I CERTIFY THAT THE FOREGOING IS A CORRECT

TRANSCRIPT FROM THE RECORD OF PROCEEDINGS

IN THE ABOVE-ENTITLED MATTER.

SUSAN A. LEE DATED: February 15, 1989

SUSAN A. LEE. CSR 2800.

CM, RPR OFFICIAL COURT REPORTER

A-97

CERTIFICATE OF SERVICE

I hereby certify that a true and correct copy of DEFEN-

DANT’S MOTION TO AMEND THE FINDINGS OF

FACT, CONCLUSIONS OF LAW, AND JUDGMENT AND

FOR ATTORNEY’S FEES: MEMORANDUM OF POINTS

AND AUTHORITIES was sent, postage prepaid, by deposit-

ing it with the United States Postal Service as first class mail,

addressed to the following counsel for plaintiffs, this 1 7th day

of March, 1989,

Darla Anderson, Esq.

Mentor Corporation

600 Pine Avenue

Goleta, CA 93114

and to

Faegre & Benson

2200 Norwest Center

90 South Seventh Street

Minneapolis, MN 55402-3901

ATTN: Alan Anderson, Esq.

by Federal Express, this 17th day of March, 1989.

EpwarD J. DaRIN

Edward J. DaRin

A-98

28 USC § 2071. Rule-making Power Generally

(a) The Supreme Court and all courts established by Act

of Congress may from time to time prescribe rules for the

conduct of their business. Such rules shall be consistent

with Acts of Congress and rules of practice and procedure

prescribed under section 2072 of this title.

(b) Any rule prescribed by a court, other than the Su-

preme Court. under subsection (a) shall be prescribed only

after giving appropriate public notice and an opportunity for

comment. Such rule shall take effect upon the date specified

by the prescribing court and shall have such effect on pending

proceedings as the prescribing court may order.

(c)(1) A rule of a district court prescribed under subsec-

tion (a) shall remain in effect unless modified or abrogated

by the judicial council of the relevant circuit.

(2) Any other rule prescribed by a court other than the

Supreme Court under subsection (a) shall remain in effect

unless modified or abrogated by the Judicial Conference.

(d) Copies of rules prescribed under subsection (a) by a

district court shall be furnished to the judicial council, and

copies of all rules prescribed by a court other than the

Supreme Court under subsection (a) shall be furnished to the

Director of the Administrative Office of the United States

Courts and made available to the public.

(e) If the prescribing court determines that there is an

immediate need for a rule. such court may proceed under

this section without public notice and opportunity for com-

ment, but such court shall promptly thereafter afford such

notice and opportunity for comment.

(f) No rule may be prescribed by a district court other

than under this section.

A-99

28 USC § 2072. Rules of Procedure And Evidence; Power To

Prescribe

(a) The Supreme Court shall have the power to prescribe

general rules of practice and procedure and rules of evidence

for cases in the United States district courts (including pro-

ceedings before magistrates thereof) and courts of appeals.

(b) Such rules shall not abridge, enlarge or modify any

substantive right. All laws in conflict with such rules shall be

of no further force or effect after such rules have taken effect.

Rule 50. Motion for a Directed Verdict and for Judgment

Notwithstanding the Verdict

(b) Motion for Judgment Notwithstanding the Verdict.

Whenever a motion for a directed verdict made at the

close of all the evidence is denied or for any reason is not

granted, the court is deemed to have submitted the action to

the jury subject to a later determination of the legal questions

raised by the motion. Not later than 10 days after entry of

judgment, a party who has moved for a directed verdict may

move to have the verdict and any judgment entered thereon

set aside and to have judgment entered in accordance with

the party’s motion for a directed verdict; or if a verdict was

not returned such party. within 10 days after the jury has

been discharged. may move for judgment in accordance with

the party’s motion for a directed verdict. A motion fora new

trial may be joined with this motion. or a new trial may be

prayed for in the alternative. If a verdict was returned the

court may allow the judgment to stand or may reopen the

judgment and either order a new trial or direct the entry of

judgment as if the requested verdict had been directed. If

no verdict was returned the court may direct the entry of

judgment as if the requested verdict had been directed or

may order a new trial.

A-100

(c) Same: Conditional Rulings on Grant of Motion.

(1) If the motion for judgment notwithstanding the ver-

dict, provided for in subdivision (b) of this rule, is granted,

the court shall also rule on the motion for a new trial, if any,

by determining whether it should be granted if the judgment

is thereafter vacated or reversed, and shall specify the grounds

for granting or denying the motion for the new trial. If the

motion for a new trial is thus conditionally granted, the order

thereon does not affect the finality of the judgment. In case

the motion for a new trial has been conditionally granted and

the judgment is reversed on appeal, the new trial shall proceed

unless the appellate court has otherwise ordered. In case the

motion for a new trial has been conditionally denied, the

appellee on appeal may assert error in that denial; and if the

judgment is reversed on appeal. subsequent proceedings shall

be in accordance with the order of the appellate court.

(2) The party whose verdict has been set aside on motion

for judgment notwithstanding the verdict may serve a motion

for a new trial pursuant to Rule 59 not later than 10 days

after entry of the judgment notwithstanding the verdict.

Rule 59. New Trials; Amendment of Judgments

(b) Time for Motion.

A motion for a new trial shall be served not later than

10 days after the entry of the judgment.

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