shine, inc. v. benson laboratories,...

1

SHINE, INC.

v.

BENSON LABORATORIES, INC.

Intellectual Property Trial Advocacy

Patent Trial Case File

(With Emphasis on Defenses)

Copyright © 2012 James F. Holderman

(Adapted by Benjamin P. Liu)

(Original Public Record Material Excepted)

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Shine v. Benson

Patent Trial Case File

Table of Contents Case File Memo .............................................................................................................................. 1

Claim 4 of the ‘264 Patent.............................................................................................................. 3

Jury Instructions in Patent Cases ................................................................................................. 5

Preliminary Jury Instructions (Given to Jury Before Trial) ...............................5

Proposed Jury Instructions ...............................................................................11

1. Submitted by Plaintiff’s Counsel .........................................................11

2. Submitted by Defendant’s Counsel .....................................................13

Final Jury Instructions (Given to Jury Before Deliberations) ..........................15

Special Verdict Form ................................................................................................................... 24

Stipulations.................................................................................................................................... 27

Final Pre-Trial Order*................................................................................................................. 33

Introduction ......................................................................................................33

Shine’s Pre-Trial Submission ..........................................................................35

Benson’s Pre-Trial Submission........................................................................41

Deposition Summaries ................................................................................................................. 52

Robert A. Miller – Perfusionist; Plaintiff’s Markman Expert .........................54

John “Ted” Lewin – Inventor for Plaintiff .......................................................68

Robert Curtis – Plaintiff’s Expert ....................................................................88

Donald Benson – Inventor for Defendant ......................................................100

Dr. Frank Gollan – Defendant’s Expert .........................................................117

Exhibits** .................................................................................................................................... 131

*Modified to primarily discuss infringement, invalidity and prior user rights.

**These are all of the available Trial Exhibits. To make this problem less voluminous,

some exhibits have been deleted. You, as counsel, must choose what exhibits you will

use at the trial and inform your opponent in advance of trial. Plaintiff’s Exhibit 18 is the

Benson BOS-10 oxygenator, which is also an exhibit available for trial.

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SHINE v. BENSON CASE FILE MEMO

To: Accelerated Trial Advocacy: Intellectual Property Students

From: Chief Judge James F. Holderman and Professor Paula Hudson Holderman

Shine v. Benson, a patent infringement case, is the case file for the Final Trial.

Claim 4 of the ‘264 Patent, which has been reproduced in the attached materials, is the

key claim in dispute. This case is based on an actual case. It was originally modified

into a case file by the American Intellectual Property Law Association for use at an

annual conference. We have continued to make further modifications for its use as a case

file by our Trial Advocacy students over the years.

The District Judge overseeing the pre-trial proceedings in this matter has ordered

pursuant to FRCP 42(b) that this trial will proceed on Plaintiff’s claims that Defendant

allegedly infringed Plaintiff’s patent and Defendant’s affirmative defenses that the

Plaintiff’s patent is invalid and that the Defendant is a prior user permitted to use the

patent.

The Plaintiff has the burden of proving infringement, the burden is a

preponderance of the evidence. The Defendants will prove its affirmative defenses of

invalidity and prior use. To prevail, the Defendants only needs to prove one of the

defenses by clear and convincing evidence.

Prior to the Final Trial, the Judge will have held a Markman hearing and will have

determined the meaning of the language in Claim 4. Those determinations have been

included in the final jury instructions provided in the case file. The jury instructions and

verdict form have been modified to address only the issues on trial.

The key to approaching any patent case is to first understand the patents and the

devices in question. The patent and device at issue in this case are blood bubble

oxygenators. Understand that it is alleged that the Benson device infringes on the Shine

patent, not on the Shine device.

Look at Figure 3 on Ex. 2C, the ‘264 patent owned by Shine. It shows that

oxygen enters from the bottom and blood enters from the side near the bottom. The

blood progresses from bottom to top by a pumping mechanism over the ribbed heating

and cooling coils which fit snugly to the inside wall. The oxygenated blood exits out the

top.

Look at Ex. 6A, a photograph of the alleged infringing Benson blood bubble

oxygenator. The blood and oxygen enter at the top of the device. They are pulled by

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gravity down over the ribbed heating and cooling coils which do not touch the inside wall.

The oxygenated blood exits out the bottom of the device.

Each side will call two live witnesses. The Plaintiff will call John “Ted” Lewin

and Robert Curtis. Donald Benson and Dr. Frank Gollan are to be called by the Defense.

The other deposition summaries and pre-trial memos have been provided to assist in

understanding the case.

A series of stipulated facts are attached as part of the case file. After reading the

stipulations, you will see that elements A-F, J and K of Claim 4 are not in dispute. You

should bring the pertinent stipulated facts to the jury’s attention during the evidence

phase of the trial. You may only use those exhibits that are provided in the case file.

You may enlarge or reproduce such exhibits as you see fit. We have blowups of several

exhibits for your use during the Final Trial, including (but not necessarily limited to)

Exhibits 1, 2C, 4, and 6C. We also have the BOS-10 (Exhibit 18) as a physical exhibit.

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Claim 4 of the ‘264 Patent*

* The entire ‘264 patent is found at the end of this case file as Exhibit 2 (beginning on

page 127). For purposes of trial presentation, Claim 4 of the ‘264 patent is broken down

into elements A-N in Exhibit 1 (page 125).

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Preliminary Jury Instructions for Patent Cases

Chief Judge James F. Holderman

Adapted from a submission by the late Honorable Helen Wilson Nies, former

Chief Judge, United States Court of Appeals for the Federal Circuit at the September 20,

1991 Judicial Intellectual Property Seminar, Winsor, Ontario, Canada, authored by the

late Honorable Giles S. Rich, who served many years as a judge of the United States

Court of Appeals for the Federal Circuit until his death in 1999 at the age of 94.

To help you understand the evidence that will be presented on behalf of the

parties, I will explain some of the legal terms that you will hear during this trial.

WHAT A PATENT IS AND WHAT IT IS GRANTED FOR

Patents are granted by the United States Government through the Patent and

Trademark Office in Washington, D.C. called the “PTO” for short. The PTO is a large

agency of about 3,000 people, about half of whom are technically educated Examiners

who examine the application for patents. The U.S. Constitution authorized Congress to

make laws for the granting of patents to inventors in order, as it says, “to promote the

progress of the useful arts.” Congress has made such laws which govern this trial, under

which over seven million patents have now been granted.

A patent is a legal document, issued by the government, giving the patentee for a

limited time, generally 20 years from the date the patent application was filed, the right,

which may be enforced in court, “to exclude others from making, using, or selling the

invention [covered by the patent] throughout the United States.”

Under the law, not every invention can be patented. The statutes provide: first,

that certain kinds of inventions can be patented and, second, that certain conditions must

be met.

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These kinds of inventions named in the statutes are: processes, machines,

manufactures, and compositions of matter and any improvement thereof.

The conditions that must be met are: (1) the invention must be new, (2) useful,

and (3) even though new, it must not have been obvious at the time it was invented.

Novelty and non-obviousness are judged against everything publicly known before the

invention as shown in earlier patents and other published material, etc. This body of

public knowledge is called “prior art.” So when you hear the lawyers or witnesses use

the phrase “prior art” they mean everything publicly known before the invention.

Another important condition designed to keep inventors from delaying too long

before applying for a patent, after the invention has become known, is that it must not

have been “patented or described in a printed publication” anywhere in the world or “in

public use or on sale in this country more than one year” before the date of the

application for a patent in the United States. Where something has been in public use or

on sale in this country, either by the inventor himself or anyone else, more than a year

before the inventor files his application for a patent, then it is also treated as “prior art.”

This is true even if the invention was made earlier than the thing publicly used or on sale.

HOW A PATENT IS OBTAINED

The statute makes a patent a kind of bargain between the inventor and the

government, representing the public. The patent will be granted in exchange for a full

disclosure of the invention. This is a further condition on the grant. The disclosure is

made in a patent application filed in the PTO, which keeps it secret until the patent is

issued.

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The application, in addition to some other parts, consists of a written description

of the invention telling what it is, how it works, how to make or use it so as to enable

others to practice it, and usually includes drawings. This is called the “specification.” In

addition to the specification, the application is required to contain “claims,” the purpose

of which, according to the statute, is to particularly point out what the applicant regards

as his invention. I must point out to you, the jury in this case, however, that the claims

have a greater significance than merely telling what the applicant thinks is his invention.

THE SIGNIFICANCE OF CLAIMS

The purpose of the examination of the application by the PTO is not just to see

that the description is adequate to understand the invention and enable one to make and

use it, but also to see that what the applicant is claiming meets the conditions for

patentability – that it is new, useful and not obvious in view of the prior art.

The numbered paragraphs of a patent, which are called the “claims,” are in fact

definitions of what the patent covers – what its limits are – and the claims alone

determine what is or is not an infringement of the patent. Claims have been compared to

the description in a deed to land, which points out what the boundaries are. Within those

boundaries, one who enters without permission of the owner is a trespasser. One who

comes within the scope of a claim is comparable to a trespasser and is called an infringer.

In law, patent infringement is a form of trespass.

THE PATENT RIGHT AS PROPERTY

The statute says that “patents shall have the attributes of personal property.” One

such attribute is that they can be bought and sold. If an inventor makes an agreement

with someone, an employer for example, to sell his patent right and records an

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assignment in the PTO before an application is issued as a patent, the PTO will issue the

patent directly to the assignee and the assignee will own the patent. Otherwise it is issued

to the applicant/inventor.

THE PROSECUTION HISTORY

In examining a patent application, the Examiner in the PTO makes a search in the

prior art to determine whether the invention as claimed is or is not new and non-obvious.

He or she advises the applicant of what prior art is found and whether he or she has

“allowed” any claim by an “Office Action.” More often than not, the initial action is a

rejection of all claims. The applicant then responds, sometimes amending claims or

submitting new ones and this may go on for some time until the PTO’s Examiner is

satisfied, even for several years. The papers built up in this procedure become the

prosecution history. The prosecution history may later be very important in determining

just what the claims mean and what they cover – that is to say, what has been patented.

This history in the past has been referred to as the “file wrapper and contents,” that being

the term used in the PTO for the cover of the file on which its contents are listed. All of

this material becomes available to the public when the patent issues.

PATENTEE’S BURDEN OF PROVING INFRINGEMENT

In a suit such as this, the patentee, the person or entity which holds the patent, has

the burden of establishing infringement of one or more claims of the patent by a

preponderance of the evidence, which means that you must be persuaded by the evidence

that it is more probably true than not true that the claims of the patent were infringed.

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DEFENDANT’S BURDEN OF PROVING DEFENSES

The defendant, the person or entity which is sued by the patent owner, may assert

a number of defenses, such as invalidity or prior use. A defendant has the burden of

establishing any one of the defenses by clear and convincing evidence, which means that

the evidence is clear and that it convinces you that the patent is invalid or that the

defendant commercially used the patented technology before the patent was filed.

OBVIOUSNESS

A patent claim will be invalid if the claimed invention would have been obvious

to a person of ordinary skill in the field of the invention at the time it was made. The

ordinary skilled person is a person of average education and training in the field of the

invention and is presumed to be aware of all of the relevant prior art. You will hear

evidence about the skill and experience of such a skilled person during the course of the

trial.

In order to prove invalidity based on obviousness, the defendant must prove by

clear and convincing evidence that Claim 4 of the '264 Patent would have been obvious

to a person of ordinary skill in the art at the time the invention was made.

PRIOR USER RIGHTS

Even if the patent is valid and there is infringement, the defendant is still not

liable if the acted in good faith, commercially used the subject matter of the claimed

invention in the United States at least one year before the filing date of the claimed

invention. This commercial use can be either in connection with an internal commercial

use or an actual commercial sale. But the commercial use will not get the defendant out

of liability if the use was abandoned.

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IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARCO ISLAND

SHINE, INC., )

)

Plaintiff, )

)

v. ) Civil Action No. (YR-4) CV 915

)

BENSON LABORATORIES, INC., )

)

Defendant. )

)

PLAINTIFF’S PROPOSED JURY INSTRUCTIONS

As to element G, the court instructs you that the phrase:

“continuous helical flute passage considerably longer than the length of

said fluid conduit”

means that the length of the flute passage when measured and compared to the length of

the fluid conduit through which the fluid may flow is found by you on consideration to be

longer, even minimally longer, than the length of the fluid conduit.

As to element H, the court instructs you that the phrase:

“said helical rib being located in contact with or closely proximate to the

inner wall of said oxygenating chamber”

means that the helical rib is sufficiently close to the inner wall of the oxygenating

chamber to allow the device to function as intended.

As to element I, the phrase:

“so that substantially all of said blood and blood foam produced by said

first means flows in contact with external surfaces of said heat transfer

fluid conduit”

means that some amount of the blood and blood foam when considered by a proper

method of measurement touches the outside surface of the heat transfer fluid conduit at

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some point in its flow, no matter how minimally or briefly, during the flowing of the

blood or blood foam through the oxygenating chamber.

13



SHINE, INC., )

)

Plaintiff, )

)


)


)

Defendant. )

DEFENDANT’S PROPOSED JURY INSTRUCTIONS





the fluid conduit is found by you to be so much longer than the length of the fluid’s flow

in the chamber of the device that you find the difference in length, upon consideration, to

be great.




means that the helical rib touches or is sufficiently close to the inner wall of the

oxygenating chamber so that the helical rib can guide the blood or the blood foam’s

movement in the oxygenating chamber.




fluid conduit”

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means that almost all of the blood and blood foam when considered by a proper method

of measurement flows over in constant contact with the heat transfer fluid conduit, during

the blood or blood foam’s flow through the chamber.

15



SHINE, INC., )

)

Plaintiff, )

)


)


)

Defendant. )

FINAL JURY INSTRUCTIONS

Members of the Jury:

Now it is my duty to instruct you on the law that applies in this case.

You are the sole judges of the facts. It is your duty to follow and to apply the

rules of law stated in these instructions.

The evidence consists of the sworn testimony of the witnesses, the exhibits

received in evidence, and the facts which have been stipulated. The opening statements

and the closing arguments of counsel are not evidence.

A stipulation is a statement of agreed facts and must be accepted as conclusively

proven.

You are the sole judges of the credibility of the witnesses and the weight to be

given their testimony. You may consider the witness’ manner while testifying, the

reasonableness of the testimony and any interest or bias the witness may have in the case.

If any witness made any prior statements which are not consistent with the testimony in

court, you may consider such conflicts and any explanations in determining the witness’

credibility.

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You have heard testimony from persons described as experts. An expert witness

is entitled to give an opinion and may also state reasons for the opinion. You should

consider the testimony of an expert like any other testimony. You may give it such

weight, if any, as you think it deserves. In determining the weight to be given the

testimony of any expert you should consider the qualifications of the expert.

In this case:

Shine is the owner of U.S. Patent No. 4,065,264, which has been referred to by its

last three numbers as “the ‘264 patent.”

Shine has sued Benson contending that Benson has infringed Claim 4 of the ‘264

patent by making, using and/or selling the Benson BOS-10 oxygenator.

Benson denies that it has infringed Claim 4 of the ‘264 patent. In addition,

Benson raises two defenses. First, Benson contends that the ‘264 patent is not valid

because it is obvious in light of what was already known at the time the patent was filed.

Benson further contends that it is a prior user of the technology not subject to the ‘264

patent.A “claim” in a patent defines, in words, the boundaries of the invention, that is,

what the patent owner is entitled to protect and to prevent others from infringing. It is

only the claims of the patent that can be infringed. The specification and drawings can,

however, be used to help understand the words in the claims.

In determining whether the accused Benson BOS-10 oxygenator infringes Claim

4 of the ‘264 patent, you must apply Claim 4 to the Benson BOS-10 oxygenator to

determine if this claim “reads on” this oxygenator, that is, if the elements of Claim 4

cover the Benson BOS-10 oxygenator. If they do, this is called literal infringement.

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As the judge of the law in this case, I have reviewed with counsel the meaning of

the elements of Claim 4 of the ‘264 patent which are in dispute. It is for you to apply the

facts as you find them to the Claim 4 elements as defined in these instructions.

I instruct you that elements A through F of Claim 4 of the ‘264 patent are not in

dispute. The parties agree they are present in defendant Benson’s BOS-10 device.





the fluid conduit is found by you to be more than just minimally longer than the length of

the fluid conduit.




means that the helical rib touches or is sufficiently close to the inner wall of the

oxygenating chamber so that the helical rib can guide the blood or the blood foam’s

movement in the oxygenating chamber.




fluid conduit”

means that almost all of the blood and blood foam when considered by a proper method

of measurement touches the heat transfer fluid conduit, no matter how minimally or

briefly, at some point during the blood or blood foam’s flow through the chamber.

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As to elements J and K, the parties agree those elements are present in defendant

Benson’s BOS-10 device.

As to elements L, M and N, the court instructs that the phrase:

“prior to substantial defoaming of the blood foam without areas of

stagnation for said blood and blood foam with a resulting long residence

time of the blood and blood foam in contact with said heat transfer fluid

conduit”

means that the blood oxygenation process occurs before a significant amount of blood is

defoamed and occurs without any stopping of the flow of the blood or blood foam and

that the blood or blood foam touches the heat transfer fluid conduit for a sufficient time to

accomplish the intended purpose of heating or cooling the blood or blood foam.

If you find that plaintiff has proven that each of these disputed elements of Claim

4 of the ‘264 patent are present in or covered by the BOS-10, then the Benson BOS-10

oxygenator “reads on” the ‘264 patent and literally infringes Claim 4 of the ‘264 patent.

The fact that the Benson oxygenator may include additional features not in Claim

4 of the ‘264 patent is of no consequence. The mere addition of features or function in

the Benson BOS-10 oxygenator does not negate or avoid infringement. Even if Benson’s

BOS-10 oxygenator is more or less efficient or performs additional functions,

infringement cannot thereby be avoided.

If you do not find that the accused Benson BOS-10 oxygenator literally infringes

Claim 4 of the ‘264 patent because plaintiff Shine has not proven one or more of the

disputed elements of the ‘264 patent, you must then consider whether the Benson BOS-

10 infringes Claim 4 under the doctrine of equivalents. Infringement under the doctrine

of equivalents exists if you find, after considering Claim 4 element by element, that any

differences between the elements of Claim 4 and the Benson BOS-10 are not substantial.

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To determine whether the difference you find between an element of the Benson BOS-10

and an element of Claim 4 are not substantial, you may consider whether the elements of

the Benson BOS-10 oxygenator perform substantially the same function in substantially

the same way to obtain substantially the same result as the respective elements in Claim 4

of the ‘264 patent.

What constitutes equivalency must be determined against the context of the patent,

the prior art, and the particular circumstances of the case. One fact is whether a person

reasonably skilled in the art would have known of the interchangeability of an element

not contained in the patent with one that is in the patent. You may not find that

defendant’s product is equivalent to a claim requirement if the result would be that the

equivalents become so broad that the claim would cover a product that was disclosed in

the prior art.

OBVIOUSNESS

In this case, Benson contends claim 4 of the 264 patent is invalid as obvious. A

patent claim is invalid if the claimed invention would have been obvious to a person of

ordinary skill in the field of the invention at the time the application was filed as of May

10, YR -9. This means that even if all the requirements of the claim cannot be found in a

single prior art reference that would anticipate the claim or constitute a statutory bar to

that claim, a person of ordinary skill in the field of the invention who knew about all this

prior art would have come up with the claimed invention.

But a patent claim composed of several requirements is not proved obvious

merely by demonstrating that each of its requirements was independently known in the

prior art. Although common sense directs one to look with care at a patent application

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that claims as innovation the combination of known requirements according to their

established functions, it is important to identify a reason that would have prompted a

person of ordinary skill in the relevant field to combine the requirements in the way the

claimed new invention does. This is so because inventions in most, if not all, instances

rely upon building blocks long since uncovered, and claimed discoveries almost of

necessity will be combinations of what, in some sense, is already known. Accordingly,

you may evaluate whether there was some teaching, suggestion, or motivation to arrive at

the claimed invention before the time of the claimed invention. Teaching, suggestions,

and motivations may be found in written references including the prior art itself.

However, teachings, suggestions, and motivations may also be found within the

knowledge of a person with ordinary skill in the art including inferences and creative

steps that a person of ordinary skill in the art would employ. Additionally, teachings,

suggestions, and motivations may be found in the nature of the problem solved by the

claimed invention.

The ultimate conclusion of whether a claim is obvious should be based on your

determination of several factual issues:

1. You must decide the level of ordinary skill in the field of the invention that

someone would have had at the time the claimed invention was made.

2. You must decide the scope and content of the prior art. In determining the scope

and content of the prior art, you must decide whether a reference is pertinent, or

analogous, to the claimed invention. Pertinent, or analogous, prior art is defined

by the nature of the problem solved by the claimed invention. It includes prior

art in the same field of endeavor as the claimed invention, regardless of the

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problems addressed by the references, and prior art from different fields

reasonably pertinent to the particular problem with which the claimed invention

is concerned. Remember that prior art is not limited to patents and published

materials, but includes the general knowledge that would have been available to

one of ordinary skill in the field of the invention.

3. You must decide what references, if any, existed between the claimed invention

and the prior art.

Finally you should consider any of the following factors that you find have been shown

by the evidence:

A. Factors tending to show nonobviousness:

1. Commercial success of the product due to the merits of the claimed invention;

2. a long-felt, but unsolved, need for the solution provided by the claimed

invention;

3. unsuccessful attempts by others to find the solution provided by the claimed

invention;

4. copying of the claimed invention by others;

5. unexpected and superior results from the claimed invention;

6. acceptance by others of the claimed invention as known by praise from others

in the field of the invention or from the licensing of the claimed invention;

7. disclosures in the prior art that criticized, discredit, or otherwise discourage

the claimed invention and would therefore tend to show that the invention was

not obvious.

8. Other evidence tending to show nonobviousness.

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B. Factors tending to show obviousness

1. independent invention of the claimed invention by others before or at about

the same time as the named inventor thought of it; and

2. other evidence tending to show obviousness.

You may consider the presence of any of the listed factors 1-7 as appropriate as

an indication that the claimed invention would not have been obvious at the time the

claimed invention was made. And you may consider the presence of the listed factors 8-9

as appropriate as an indication that the claimed invention would have been obvious at

such time. Although you should consider any evidence of these factors, the relevance and

importance of any of them to your decision on whether the claimed invention would have

been obvious is up to you.

PRIOR USER RIGHT

The prior user right will also discharge Benson from infringing liability if Benson

could establish this right by clear and convincing evidence. Benson contends that it acted

in good faith, commercially used the machine of claim 4 of the ‘264 patent in the United

States, in commercial process, at least one year before the effective filing date of the ‘264

patent. Benson will not be liable if you find that the subject matter claimed in claim 4 of

the ‘264 patent was commercially used by Benson in the United States before May 10,

YR-10. The commercial use could either be in connection with an internal commercial

use or an actual arm’s length sale. Also, even if there is commercial use, this commercial

use cannot be abandoned.

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Benson has the burden to prove the prior commercial use and the use was not

abandoned by clear and convincing evidence. If you find Benson is able to establish this,

Benson will not be held liable even if you find there is infringement.

As to the issues on trial before you, plaintiff Shine, Inc. has the burden of proving

that defendant Benson Laboratories’ BOS-10 oxygenator infringes each element of Claim

4 of the ‘264 patent by a preponderance of the evidence; preponderance of the evidence

means more likely true than not true.

If you find that Shine, who has the burden of proving infringement, has failed to

meet its burden, your verdict must be for Benson. If you find that Benson, who has the

burden of proving invalidity and prior user right defenses, meet its burden for either one

of the two defenses, your verdict must also be for Benson even if Shine met its burden.

A verdict form, with the specific questions you, as the jury must answer, has been

prepared for your use.

24



SHINE, INC., )

)

Plaintiff, )

)


)


)

Defendant. )

)

SPECIAL VERDICT FORM

We, the jury, in answering the following questions state our verdict to be as follows:

Question No. 1 Do you find that plaintiff Shine has proven by a preponderance of

the evidence that the accused Benson BOS-10 oxygenator literally

infringes Claim 4 of the ‘264 patent?

Yes ________ No ________

Question No. 2 Do you find that plaintiff Shine has proven by a preponderance of

the evidence that the accused Benson BOS-10 oxygenator infringes

Claim 4 of the ‘264 patent under the doctrine of equivalents?

Yes ________ No ________

Question No. 3 Do you find that the defendant Benson has proven by clear and

convincing evidence that Claim 4 of the '264 Patent is obvious?

Yes ________ No _________

Question No. 4 Do you find that the defendant Benson has proven by clear and

convincing evidence that it is a prior user of the subject matter

covered by Claim 4 of the ‘264 patent?

Yes ________ No _________

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_________________________________ ____________________________

Jury Foreperson

_________________________________ ____________________________

_________________________________ ____________________________

_________________________________ ____________________________

_________________________________ ____________________________

_________________________________ ____________________________

Date:

26



SHINE, INC., )

)

Plaintiff, )

)


)


)

Defendant. )

)

STIPULATION BETWEEN THE PARTIES

The parties have agreed and stipulated to the following facts which are to be

considered by the jury as proven:

1. United States Patent No. 4,065,264, which is the patent in suit and as to

which Benson is accused of infringing Claim 4, was filed in the name of John E. Lewin,

and such patent is assigned to and owned by Shine, Inc.

2. The application for U.S. Patent No. 4,065,264, referred to hereinafter as

the ‘264 patent, was filed in the United States Patent Office on May 10, (YR-9) and

issued as a patent on December 27, (YR-8).

3. The ‘264 patent relates to bubble blood oxygenators.

4. The claim in issue, Claim 4 of the ‘264 patent, is directed to blood

oxygenators for both regulating the temperature of blood and oxygenating the blood by

means of the bubble blood oxygenator.

5. Blood oxygenators represent the lung part of what is commonly referred to

as the heart-lung machine, and blood oxygenators are used most often during open heart

by-pass operations wherein surgical repairs are made to the heart.

27

6. During an open heart by-pass operation, it is necessary to oxygenate the

blood, that is, to add oxygen to the blood much as the human lung would otherwise do.

7. During a by-pass operation, it is desirable to cool the blood, and reheat the

blood at the operation’s conclusion.

8. A bubble blood oxygenator is one form of blood oxygenator in which the

oxygen is, in effect, bubbled into and mixed with the blood.

9. The model of blood oxygenator which is manufactured and sold by

Benson is designed as the BOS-10.

10. Benson’s BOS-10 oxygenator, which is accused of infringing Claim 4 of

the ‘264 patent, serves to oxygenate the blood and also cool and heat the blood.

11. Benson’s BOS-10 blood oxygenator is used by Benson customers for

regulating the temperature of venous blood in an extracorporeal blood circuit and

simultaneously oxygenating the venous blood.

12. Benson first sold its BOS-10 blood oxygenator in January (YR-7).

13. Benson BOS-10 oxygenator contains an integral heat exchanger which is

used to cool and heat the blood.

14. The Benson BOS-10 oxygenator contains an oxygenating chamber.

15. The Benson BOS-10 oxygenator contains a means for introducing blood

and bubbles of oxygen into the oxygenating chamber for forming blood foam within the

chamber.

16. The Benson BOS-10 oxygenator contains a means for both (a)

contributing to the transfer of oxygen into the blood and removing carbon dioxide from

the blood and (b) regulating the temperature of the blood.

28

17. The Benson BOS-10 oxygenator contains a heat transfer fluid conduit

including heat exchange fluid inlet and outlet means.

18. Benson at one time manufactured and sold other bubble blood oxygenators

which it designed as Q-100, Q-200, and Q-200A, hereinafter referred to as the Q-series

blood oxygenators.

19. The Q-series blood oxygenators are no longer manufactured and sold by

Benson.

20. Shine manufactures and sells bubble blood oxygenators, which it has

designated Model S-100.

21. The Shine S-100 oxygenator contains an integral heat exchanger which is

used to cool and heat the blood.

22. The Shine S-100 oxygenator contains an oxygenating chamber.

23. The Shine S-100 oxygenator contains means for introducing blood and

bubbles of oxygen into the oxygenating chamber for forming blood foam within the

chamber.

24. The Shine S-100 oxygenator contains means for both (a) contributing to

the transfer of oxygen into the blood and removing carbon dioxide from the blood and (b)

regulating the temperature of the blood.

25. The Shine S-100 oxygenator contains a heat transfer fluid conduit

including heat exchange fluid inlet and outlet means and has a continuous hollow helical

rib along its length.

29

26. The Shine S-100 oxygenator contains an integral heat exchanger coil

which is in the form of a ribbed tube in a helical rib configuration and which is made of

aluminum, and in which the aluminum is coated with a polyurethane coating.

27. The aluminum ribbed tube used in the Shine S-100 oxygenator was

purchased from the Turbotec Company, also known as the Spiral Tubing Corporation.

28. Prior to the (YR-9), Shine was not in the business of selling blood

oxygenators.

29. Benson first learned of the Shine S-100 blood oxygenator in about

November (YR-9) when it obtained four Shine S-100 blood oxygenators which were

being test marketed at the time.

30. Benson evaluated a Shine S-100 oxygenator in about December (YR-9)

and January (YR-8).

31. Benson first learned of the Shine ’264 patent on January 9, (YR-7).

32. Benson was advised by a letter from Shine dated November 13, (YR-5)

that Shine considered the BOS-10 oxygenator to constitute an infringement of the ‘264

patent.

30

Shine v. Benson

Final Pre-Trial Order

Table of Contents

5

Introduction to Pre-Trial Order ........................................................................................................ 32

Shine’s Pre-Trial Submission ............................................................................................................. 34

Shine’s Statement of the Case ...........................................................................34

Shine’s Legal Authorities ..................................................................................36

1. Infringement ...............................................................................................36 10

2. Validity ......................................................................................................37

3. Prior User Defense .....................................................................................39

Benson’s Pre-Trial Submission .......................................................................................................... 40

A. Benson’s Statement of the Case .............................................................................40

1. Non-Infringement ......................................................................................44 15

2. Validity ......................................................................................................46


B. Benson’s Legal Authorities ....................................................................................47

1. Infringement ..............................................................................................47

2. Damages .....................................................................................................49 20


25

30

35

ROBERT A. MILLER

31



5

SHINE, INC., )

)

Plaintiff, )

)

v. ) Civil Action No. (YR-4) CV 915 10

)

BENSON LABORATORIES, INC., ) PRE-TRIAL ORDER

)

Defendant. )

) 15

I. INTRODUCTION TO PRE-TRIAL ORDER

This is an action for patent infringement brought by plaintiff Shine, Inc. (“Shine”)

against defendant Benson Laboratories, Inc. (“Benson”). Both parties are Florida

corporations having their principal place of business in Florida. Shine asserts that Claim 4 of 20

U.S. Patent No. 4,065,264 (“’264 patent”) has been infringed by the manufacture, use and

sale of Benson’s blood oxygenators.

The ‘264 patent was filed May 10, (YR-9) by the inventor, John E. Lewin. At the

time of filing, the application was assigned to Lewin’s employer, Shine. This application

matured into the ‘264 patent on December 27, (YR-8). 25

Shine’s suit for infringement was filed July 1, (YR-4). On July 20, (YR-4) Benson

answered and counterclaimed, seeking a declaration that the ‘264 patent is invalid and not

infringed. Shine answered the counterclaim on August 4, (YR-4). After discovery and

briefing, the court dismissed Benson’s invalidity counterclaim on summary judgment

September 5, (YR-1). 30

ROBERT A. MILLER

32

Federal jurisdiction is invoked upon the grounds that this action arises under the

Patent Laws for the United States, Title 35, United States Code. This Court has jurisdiction

over Shine’s claim under 28 U.S.C. § 1338 and over Benson’s counterclaim under 28 U.S.C.

§ 2201 and § 2202. Venue is proper in this district for Shine’s claim under 28 U.S.C. 1400(b)

and for Benson’s counterclaim under 28 U.S.C. § 1351. The facts requisite to federal 5

jurisdiction and venue are admitted by the parties.

A blood oxygenator, as its name suggests, is used to add oxygen to, or “oxygenate”

blood. This device is used during open heart surgery and other surgical procedures where it

is necessary to stop the heart to assume the function of the patient’s lungs, adding oxygen

and removing carbon dioxide from the patient’s blood. A pump assumes the function of the 10

heart, removing blood from the patient, pumping it through the oxygenator, and returning it

back to the patient.

It is well known that a patient requires less oxygen when body temperature is reduced.

Accordingly, it has been practice during such surgery to cool the blood in order to lower

body temperature and reduce the amount of oxygenation required. The invention disclosed 15

in the ‘264 patent performs each of these three basic functions, i.e., it pumps, oxygenates,

and cools the patient’s blood during this surgery. At the end of the surgical procedure the

invention then warms the blood back to or near the normal temperature.

Both Shine and Benson manufacture and sell blood oxygenators. The Shine

oxygenator, designated the Model S-100, was introduced into the commercial marketplace 20

beginning in mid (YR-8) with a patent pending designation. Benson’s allegedly infringing

oxygenator, designated Model BOS-10, was introduced into the marketplace in (YR-7).

ROBERT A. MILLER

33

In this suit Shine seeks an unspecified amount of damages, which it has requested to

be trebled under 35 U.S.C. § 284 for alleged willful infringement of the ‘264 patent. Shine

also seeks an injunction against future infringement of the ‘264 patent by Benson.

II. SHINE’S PRE-TRIAL SUBMISSION

A. Shine’s Statement of the Case 5

In the present patent infringement action, Shine asserts that Claim 4 of the ‘264 patent

is infringed by defendant Benson’s manufacture, use, and sale of the BOS-10 blood

oxygenator. The patent in suit is U.S. Patent No. 4,065,264, which issued to the inventor, Mr.

John (“Ted”) Lewin, and which was assigned by him to Shine. Shine contends and will

prove at trial that Benson’s BOS-10 blood oxygenator infringes Claim 4 of the ‘264 patent 10

under 35 U.S.C. §271(a).

The ‘264 patent describes and claims a unique blood oxygenator. A blood

oxygenator, which is the lung portion of what is commonly referred to as a heart-lung

machine, is typically utilized during open heart bypass operations to assume the function of

the human lungs, i.e., to remove carbon dioxide from the blood and to add oxygen. The 15

blood oxygenator of the ‘264 patent also serves to heat and cool the blood as is also

necessary during by-pass operations.

After learning in about November (YR-9) of Shine’s S-100 oxygenator, made in

accordance with the teachings of the ‘264 patent, and after studying and evaluating the Shine

oxygenator from December (YR-9) on, Benson thereafter manufactured its BOS-10 20

oxygenator based upon Shine’s product and began selling the same in about January (YR-7).

After learning on about January 9, (YR-7) of the issuance of the ‘264 patent, and in the

ROBERT A. MILLER

34

absence of a competent written opinion of counsel, Benson deliberately continued to utilize

the invention thereof and to infringe Claim 4 of the ‘264 patent.

Shine further contends in this regard that Benson knowingly and deliberately

continued to infringe Claim 4, even after being expressly advised by Shine on or about

November 13, (YR-5) that Benson’s BOS-10 blood oxygenator was deemed to infringe. 5

Shine contends that Claim 4 of the ‘264 patent is valid, is accorded a presumption of

validity by 35 U.S.C. § 282 and not obvious. Benson cannot meet its burden to provide clear

and convincing evidence because its proof merely selected and combined references based on

impermissible hindsight. Its reference device is a glass oxygenator that Benson’s expert

admits is not for human use and therefore cannot be modified to perform the purpose of 10

being a blood oxygenator. The relevant prior art does not show any teaching, suggestion or

motivation to make the blood oxygenator for human treatment.

Shine contends that its S-100 blood oxygenator is made in accordance with the

teachings of the ‘264 patent. This blood oxygenator was introduced into the commercial

marketplace in (YR-8) and was greeted in the industry with immediate widespread 15

acceptance. It has continued to be a huge commercial success to this day. Benson’s BOS-10

oxygenator is remarkably similar to the Shine S-100 oxygenator in design, operation, and

results. This device was introduced into the commercial marketplace in January (YR-7). It

too has been commercially successful. The commercial success of Shine’s S-100 product due

to the merits of the claimed invention and it solved the long-felt but unsolved need for the 20

blood oxygenator. The copying of the claimed invention by Benson also tends to show

nonobviousness. Shine also contends that Benson is not a qualified prior user of the

‘264 patent under 35 U.S.C. § 273. The prior user defense is only available if Benson

ROBERT A. MILLER

35

commercially used the BOS-10 oxygenator more than 1 year before the filing of the ‘264

patent in May (YR-9). Therefore, the defense does not apply to the BOS-10 oxygenator

because its commercial use did not begin until November (YR-9) when BOS-10 was

submitted to the FDA for premarketing review.

B. Shine’s Legal Authorities 5

1. Infringement

Benson’s manufacture, use and sale of its BOS-10 blood oxygenator within the

territorial limits of the United States infringes Claim 4 of the ‘264 patent. Shine, as the

patentee, bears the burden of proving infringement by the “preponderance of the evidence.”

Tanabe Seiyaku Co. v. U.S. ITC, 109 F.3d 726, 731 (Fed. Cir. 1997). “To establish [patent] 10

infringement, every element and limitation of the claim must be present in the accused device,

literally or by an equivalent.” Inpro II Licensing, S.A.R.L. v. T-Mobile USA, Inc., 450 F.3d

1350, 1358 (Fed. Cir. 2006).

Infringement analysis is a two-step process: (1) determining the meaning and scope of

the claims, and (2) comparing the properly construed claims to the accused method. See 15

Markman v. Westview Instruments, Inc., 517 U.S. 370, 374 (1996) (“Victory in an

infringement suit require a finding that the patent claim covers the alleged infringer’s product

or process, which in turn necessitates a determination of what the words in the claim mean.”)

(internal quotations omitted).

If the accused Benson BOS-10 blood oxygenator falls within the words of Claim 4 of 20

the ‘264 patent, this claim is literally infringed and that is the end of it. Amhil Enter., Ltd. v.

Wawa, Inc., 81 F.3d 1554, 1562 (Fed. Cir. 1996). Even if the words of a patent claim do not

literally cover a product or process, that product or process will nevertheless infringe the

ROBERT A. MILLER

36

patent under the doctrine of equivalents if it performs substantially the same function in

substantially the same way to obtain the same result. Graver Tank & Mfg. Co. v. Lindie Air

Prods. Co., 339 U.S. at 605, 608 (1950); Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d

931 (Fed. Cir. 1987), cert. denied, 108 S. Ct. 1226 (1988). The rationale for the doctrine of

equivalents is that to limit the scope of protection to only a literal reading of the claims 5

would “convert the protection of the patent grant into a hollow and useless thing.” Graver,

339 U.S. at 607.

2. Validity

The obviousness analysis must focus on each claim as a whole. An obviousness

inquiry must be conducted using the objective framework set forth in Graham v. John Deere 10

Co. of Kansas City, 383 U.S. 1 (1966). KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1734

(2007). This framework requires the Court to: (1) determine the scope and content of the

prior art; (2) ascertain the differences between the prior art and the claims at issue; and (3)

resolve the level of ordinary skill in the pertinent art. Graham, 383 U.S. at 17. A showing of

obviousness requires a reason to combine or modify prior art references, coupled with a 15

reasonable expectation of success. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough

Corp., 320 F.3d 1339, 1354 (Fed. Cir. 2003). In addition, the Court must consider secondary

considerations, such as commercial success of the invention, long felt but unsolved needs,

failure of others, etc., to assess whether or not the claimed subject matter would have been

obvious at the time of the invention. Id. at 17-18. The mere presence in the prior art of each 20

element recited in a claim does not render the claim obvious. Only when the prior art

suggests the entirety of a claimed combination is the claim obvious. In KSR, the Supreme

Court explained:

ROBERT A. MILLER

37

As is clear from cases such as Adams, a patent composed of several elements is not

proved obvious merely by demonstrating that each of its elements was, independently,

known in the prior art. Although common sense directs one to look with care at a

patent application that claims as innovation the combination of two known devices

according to their established functions, it can be important to identify a reason that 5

would have prompted a person of ordinary skill in the relevant field to combine the

elements in the way the claimed new invention does. This is so because inventions in

most, if not all, instances rely upon building blocks long since uncovered, and

claimed discoveries almost of necessity will be combinations of what, in some sense,

is already known. Id. at 1741 (citing United States v. Adams, 383 U.S. 39 (1966)). 10

Where one attempts to invalidate a patent for obviousness based on a primary reference as

modified by a secondary reference to achieve the claimed invention, there must be a showing

that the prior art would have suggested the modification. See Takeda Chem. Indus. v.

Alphapharm Ply., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (“in order to find a prima facie 15

case of unpatentability ... a showing that the prior art would have suggested making the

specific molecular modifications necessary to achieve the claimed invention was also

required”) (quotation omitted). In other words, there must be “a reason that would have

prompted a person of ordinary skill in the relevant field to combine the elements in the way

the claimed new invention does.” KSR, 127 S. Ct. at 1741 (emphasis added). 20

Only the knowledge of one having ordinary skill in the art and the prior art available

to him at the time the invention was made should be considered when assessing the issue of

obviousness. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir.

1983). The use of hindsight in identifying a reason to combine the references is prohibited.

See KSR, 127 S. Ct. at 1742 (“A factfiner should be aware, of course, of the distortion 25

caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning.”)

(citing Graham, 383 U.S. at 36). Therefore, it is impermissible to consider the inventive

teachings of the patent itself in determining whether there was a reason to combine

ROBERT A. MILLER

38

references. In re Dembiczak, 175 F.3d 994,998-99 (Fed. Cir. 1999) (warning against falling

victim “to the insidious effect of a hindsight syndrome wherein that which only the inventor

taught is used against its teacher”) (quoting W.L. Gore, 721 F.2d at 1553).

The nonobviousness statute also provides that “[p]atentability shall not be negatived

by the manner in which the invention was made.” 35 U.S.C. § 103(a) (2007). Under this 5

section of the statute, the path that leads an inventor to the invention is expressly made

irrelevant to the issue of patentability. Life Techs., Inc. v. Clontech Lab., Inc., 224 F.3d 1320,

1325 (Fed. Cir. 2000). Thus, an inventors' reliance on a particular piece of prior art, his use

of such prior art as a starting point for making the invention, and any motivations he derived

from it have no bearing on the obviousness inquiry. Id The only relevant inquiry is whether 10

the teachings of the prior art as a whole “would have rendered the claimed invention obvious

to one of ordinary skill in the art; this inquiry, as a matter of law, is independent of the

motivations that led the inventors to the claimed invention.” Id.

3. Prior User Defense

The prior user right requires defendants acted in good faith, commercially used the 15

machine based on the relevant patent in the United States, in commercial process, at least one

year before the effective filing date of the patent. 35 U.S.C. §273. The prior user right is not

available to Benson because the subject matter claimed in claim 4 of the ‘264 patent was not

commercially used by Benson in the United States before May 10, YR-10. Also, even if there

is commercial use, this commercial use cannot be abandoned. Benson could not meet the 20

burden to prove the prior commercial use and the use was not abandoned.

III. BENSON’S PRE-TRIAL SUBMISSION

A. Benson’s Statement of the Case

ROBERT A. MILLER

39

This patent litigation involves two of the largest manufacturers of blood oxygenators,

Benson Laboratories Inc., and Shine, Inc. These devices constitute the subject matter of this

litigation.

Twenty years ago, Donald Benson was employed as an engineer for Edwards

Laboratories, a manufacturer of medical devices in Irvine, California. Mr. Benson was 5

working to develop improvements for a medical device called a blood oxygenator, which is

used in open heart surgery, that Edwards was considering manufacturing. Edwards

concluded that it would not pursue the blood oxygenator work done by Mr. Benson, and he

subsequently purchased the rights of Edwards Laboratories in his blood oxygenator

development and formed his own company, Benson Laboratories, Inc., in order to pioneer 10

the manufacture of blood oxygenators in the world. Benson Laboratories has sold over

1,000,000 blood oxygenators to date and holds a wide variety of patents in the blood

oxygenator field.

At about the same time that Benson was formed, Jim Shine, a co-worker of Mr.

Benson’s at Edwards, also left Edwards and founded a company named Shine, Inc. Initially, 15

Shine manufactured artificial heart valves. In mid (YR-8), Shine expanded its product line to

include a blood oxygenator designated the S-100 and began competing with Benson in this

area.

From (YR-9) to (YR-8) Shine prosecuted a series of patent applications in the U.S.

Patent Offices. One of these applications subsequently issued into the ‘264 patent, the 20

subject of this lawsuit. In July (YR-4), over 3 ½ years after the ‘264 patent issued and the

Benson oxygenators had been on the market, Shine brought suit alleging infringement of

ROBERT A. MILLER

40

Claim 4 of the ‘264 patent. Benson promptly answered and counterclaimed, seeking a

declaration, inter alia, that the ‘264 patent was invalid and not infringed.

It is Benson’s firm belief that the jury and this Court will find that Claim 4 of the ‘264

patent is not infringed by the Benson BOS-10 blood oxygenator, that Claim 4 is invalid for

being obvious, or that Benson is otherwise not liable under its prior user rights of using the 5

oxygenator described in Claim 4 of the ‘264 patent.

Shine, as patentee, bears the burden of demonstrating that the Benson device is

covered by Claim 4. To understand why the BOS-10 oxygenator does not infringe is to

understand the fundamentally different mode of operation of the Benson and Shine devices.

The blood and blood foam in the Benson oxygenator gently cascade down over the heat 10

exchange coil under the pull of gravity. In contrast, the blood and blood foam in the Shine S-

100 device and patents are propelled up under pressure, over and around the heat exchanger

coil, significantly agitating the blood and blood foam. Almost all of the blood and blood

foam come in contact with the heat exchange coil in the Shine device, while only half of the

blood and blood foam come in contact with the heat exchange coil in the Benson device. 15

An additional significant difference relates to the length of the blood flow path in the

respective oxygenators. Since only half the blood and blood foam flow down over the heat

exchanger in the Benson oxygenator, the length of the blood flow path of the other half is on

the order of the length of the oxygenating chamber inner wall column. In sharp contrast, the

helix-on-helix design of the Shine device serves to substantially extend the length of the 20

blood flow path as the blood flows around and around the heat exchanger conduit through the

helix-on-the-helix. (See in this regard the specification of the ‘264 patent at col. 9, lines 7-

ROBERT A. MILLER

41

14). This claim element of extended length flow paths simply is not met in the BOS-10

oxygenator.

A significant structural difference between the Benson and Shine oxygenator relates

to the size of the gap between the outer portions of the ribs and the inner portion of the

bubble column. The Benson device can and does utilize a much larger gap than can the 5

Shine device, because the Benson oxygenator flows blood down over the coils whereas the

Shine device forces blood and blood foam up over the coils, utilizing the wall and small gap

to contain the blood. This requisite element of Claim 4 is not met by the BOS-10 oxygenator.

The ‘264 patent follows prior art in that it is directed to a blood oxygenator where the

heat exchanger is positioned in the oxygenator bubble chamber. Simply stated, Mr. Lewin’s 10

alleged invention was to place the heat exchanger tubing in a coil configuration within the

oxygenator bubble column and to use tubing having an external rib.

The ‘264 patent discloses a blood oxygenator with a ribbed heat exchanger contained

within the oxygenator column. Claim 4 requires that the oxygenator contain an integral heat

exchanger and a continuous hollow helical rib which is “in contact with or closely proximate 15

to” the inner wall of the oxygenation chamber. In addition, “substantially all” of the blood

and blood foam must flow in contact with the external surface of the heat exchange tube.

The rib and the inner wall of the oxygenation chamber must form a restricted area, extended

length flow path through which the blood and oxygen flow. Significantly, the oxygenator

must be constructed so as to present substantially uniform flow impedance to the blood, lest 20

the blood and oxygen take a path of less resistance and bypass the heat exchanger section.

John E. Lewin, the named inventor of the patent in suit, joined Shine in February of

(YR-10) with no prior experience in medical devices. Indeed, until his job interview one

ROBERT A. MILLER

42

week prior to joining Shine, Mr. Lewin had no knowledge of, or had ever heard of, blood

oxygenators. He did have approximately 25 years of experience in aircraft design,

specifically in aircraft propulsion systems. He began this task by reviewing magazine

advertisements and articles. Within a few weeks he happened upon an ad placed by Spiral

Tubing Corporation (also known as Turbotec). 5

Mr. Lewin got the “notion” of using ribbed, helical tubing when he saw the

advertisement. The advertisement was quite explicit and left little to the imagination. It

discloses as heat exchangers virtually the identical tubing construction used in the S-100.

The ad is proudly headed “TWISTED TUBING UPS HEAT TRANSFER.” The tubing was

expressly promoted as generating fluid turbulence and increasing the amount of heat transfer 10

on both sides of the walls. The helical, spirally ribbed tubing, as graphically depicted in the

advertisement, clearly comes within the scope of the heat exchanger recitations of Claim 4 of

the ‘264 patent.

Mr. Lewin contacted Turbotec in order to obtain samples of the tubing for addition to

the Shine oxygenator and for test purposes. The request was directed to the shape similar, if 15

not identical to, the helical, spirally ribbed shape disclosed in the ad. As some evidence of

the pedestrian nature of Mr. Lewin’s request, Turbotec responded with a price quotation

within 24 hours. By the date of Shine’s request, Turbotec had produced approximately

200,000 feet of the Turbotec tubing.

The tubing as obtained and tested was incorporated into the Shine oxygenator with 20

only two well-known expedients. The first was to employ a larger diameter tubing to reduce

the pressure drop across the tube. The second was to coat the outer surface of the tubing with

a biocompatible plastic coating.

ROBERT A. MILLER

43

1. Non-Infringement

To understand why the Benson BOS-10 oxygenator does not infringe Claim 4 of the

‘264 patent is to understand the fundamentally different method of operation of the Benson

device and the disclosed Shine device. Shine forces the blood and oxygen up past the heat

exchanger while Benson allows it to flow downward onto the heat exchanger aided by 5

gravity. The oxygenator which Shine discloses in the ‘264 patent acts by forcing blood and

oxygen under pressure against gravity, up over the heat exchanger. The pressurized blood

and oxygen take the path of least resistance up the chamber. This presents a potential

problem for the Shine device. If the gap between the ribs and the wall of the oxygenation

chamber is not very small the blood will flow through the gap rather than over the heat 10

exchanger coil, and in so doing bypass the heat exchanging steps. Substantially uniform flow

impedance must be presented to the pressurized blood to obtain the results called out in the

patent.

In contrast, the blood and oxygen in the Benson BOS-10 oxygenator flow down over

the coils aided by gravity. Because the blood is not under pressure it need not be constrained 15

by the wall of the oxygenator chamber. The blood flow path resulting from this downward

flow is substantially different from that present in the pressurized upward flow of the Shine

device.

The first primary point of non-infringement arising from the fundamentally different

mode of operation of the Benson and Shine devices relates to the claim phrase requiring 20

“substantially all” of the blood and blood foam to contact the heat exchanger coil. The gentle

down flow action for the Benson device cascades the blood and blood foam only partially

ROBERT A. MILLER

44

over the heat exchange coil, and does not result in substantially all of the blood and blood

foam contacting the heat exchange coil.

Secondly, Claim 4 defines the gap as requiring the rib to be “in contact with or

closely proximate to” the inner wall of the oxygenating chamber. The heat exchanger in the

Benson BOS-10 oxygenator is clearly not “in contact with” the inner walls. The gap is larger 5

than that which would allow successful operation in an upward (Shine) direction. In fact the

gap in the Benson BOS-10 device is over twice as large as the Shine gap. In the Shine device,

the wall of the oxygenating chamber provides a constraining structure to the passage

consisting of the conduit, the ribs and the walls. There is no corresponding closed or

substantially closed structure in the Benson BOS-10 oxygenator. 10

The final major point of non-infringement has to do with the length of the blood flow

path through the oxygenator. Claim 4 requires that the flow path of the blood be

substantially longer than it would be if the heat exchanger were removed. The text of the

‘264 patent states that:

[A] substantial portion of the blood and blood foam [in the Shine design] 15

appeared to actually follow the helical paths around the heat exchanger tubes

defined by the triple helix pattern of the flutes – paths considerably longer

than the length of the blood chamber and heat transfer fluid tube.

In sharp contrast, the heat exchanger in the Benson BOS-10 oxygenator does not serve to 20

elongate the flow paths. The flow path length is virtually identical to the length of the blood

chamber because blood flows down the inner walls of the oxygenating/heat exchanger

chamber.

2. Invalidity

Benson can meet its burden of showing that Claim 4 of the ‘264 patent is obvious by 25

clear and convincing evidence because known bubble oxygenators and tubing material make

ROBERT A. MILLER

45

obvious that the heat transfer conduit in a bubble oxygenator can feature helical ribs on its

external surface.

Claim 4 of the ‘264 patent describes an obvious combination of known bubble

oxygenators with TurboTec having efficient heat transfer capability. Bubble oxygenators

were well known and described in old medical textbooks when Shane filed the ‘264 patent 9 5

years ago. At the time the medical field had also used ribbed tubes with good heat transfer

capability in artificial kidney machines and artificial hearts. When combined, they provided

every element.

Mr. Levin merely adopted the ribbed tube to form a heat transfer fluid conduit for

heat exchange, a purpose that is not only predictable, but in fact is the exact same purpose of 10

what the tube was advertized: “TWISTED TUBING UPS HEAT TRANSFER.” As

mentioned earlier, it is the advertisement that gave Mr. Lewin the “notion” of using ribbed,

helical tubing. Although he made much of the water spay in the testing lab, the remainder of

Mr. Lewin’s work consists of routine experimentation such as varying the diameter of the

tubing or coating the metal with a biocompatible plastic coating—both of which are well 15

within a person of ordinary skill in the art.

4. Prior User Right

Benson can meet its burden of showing that it is a prior user of the subject of the

Claim 4 of the ‘264 patent because it commercially used the subject matter of Claim 4 of the

‘264 patent for a commercial process more than 1 year before the application for the ‘264 20

patent was filed. As early as April (YR-10), Benson commercially sold 25 oxygenators to

Cornell University in an arm’s length transaction, where the surgical clinic of the veterinary

medicine school used these oxygenators commercially on dogs. These oxygenators are

ROBERT A. MILLER

46

disposable bubble oxygenators featuring a heat transfer fluid conduit having a helical rib that

is made from TurboTec helical tubes. To the extent Shine contends that the accused Benson

BOS-10 oxygenator features such design (a contention Benson disagrees as discussed under

the infringement section), these 25 oxygenators demonstrate that Benson is a prior user of the

technology and therefore not liable for infringement. 5

B. Benson’s Legal Authorities

1. Infringement

The infringement analysis is a two-step process: (1) determining the meaning and

scope of the claims, and (2) comparing the properly construed claims to the accused method.

See Markman v. Westview Instruments, Inc., 517 U.S. 370, 374 (1996) (“Victory in an 10

infringement suit requires a finding that the patent claim covers the alleged infringer’s

product or process, which in turn necessitates a determination of what the words in the claim

mean.”) (internal quotations omitted). Claim construction is a matter of law for a court to

determine. Id. at 390. When interpreting the meaning of patent claim terms, a district court

is to look first to the intrinsic evidence, e.g., the claims themselves, the specification, the 15

prosecution history, and the prior art cited within the patent, giving the greatest weight to the

patent’s claim language and specification. Phillips v. AWH Corp., 415 F.3d 1303, 1314-18

(Fed. Cir. 2005). A court may also consider extrinsic evidence such as expert testimony,

treatises, and dictionaries when appropriate, but extrinsic evidence “is less significant than

the intrinsic record in determining the legally operative meaning of claim language.” Id. at 20

1315, 1320-21.

The file wrapper consists of the record of the proceedings between the applicant and

the Patent Office. However, where the patent applicant has amended, narrowed, or otherwise

ROBERT A. MILLER

47

limited the claims in the course of prosecution of his patent he may not later reclaim that

which he gave up. The applicant may not argue for a narrow construction before the Patent

Office and a broad construction before the courts. Id., 384 F.2d at 399.

The second step in determining infringement consists of applying the claims, as

construed, to the accused device. This phase presents a question of fact for the jury which 5

must be established by the patentee by a preponderance of the evidence. Infringement may

be made out under two theories. The first approach requires that the patentee show that the

device falls literally within wording of the claims. The second approach invokes the doctrine

of equivalents where there is no literal infringement. The doctrine provides that a structure

infringes if it performs substantially the same function in substantially the same way and 10

achieves the same result as the claimed invention. Graver Tank & Mfg. Co. v. Linde Air

Prod. Co., 339 U.S. 605, 607 (1950). The scope of equivalents in this case is narrow because

patents on mechanical combinations of old elements are entitled to little or no range of

equivalents. Marquip, Inc. v. Fosber Am., Inc., 198 F.3d 1363, 1367 (Fed. Cir. 1999).

Moreover, the doctrine may not be used to recapture that which has been given up during the 15

course of prosecution. Edwards Lifesciences L.L.C. v. Cook Inc., 582 F.3d 1322, 1336 (Fed.

Cir. 2009).

2. Obviousness

35 U.S.C. §103 (a) states:

A patent may not be obtained though the invention is not identically disclosed or 20

described as set forth in section 102 of this titled, if the differences between the

subject matter sought to be patented and the prior art are such that the subject matter

as a whole would have been obvious at the time the invention was made to a person

having ordinary skill in the art to which said subject matter pertains. Patentability

shall not be negatived by the manner in which the invention was made. 25

ROBERT A. MILLER

48

Thus, a claim is obvious when the differences between the subject matter of the claim and the

prior art are such that the subject matter as a whole would have been obvious at the time the

invention was made to a person of ordinary skill in the art. KSR Int'l Co. v. Teleflex, Inc.,

127 S. Ct. 1727, 1734 (2007).

Obviousness is a question of law based upon underlying facts, which are (1) the scope 5

and content of the prior art; (2) the level of ordinary skill in the prior art; and (3) the

differences between the claimed invention and the prior art. KSR, 127 S. Ct. at 1734. At

times, objective evidence of non-obviousness might also be utilized to give light to the

circumstances surrounding the origin of the claimed subject matter. Id.; Graham v. John

Deere Co., 383 U.S. at 18. 10

If a person of ordinary skill can implement a predictable variation of the prior art, §

103 likely bars the patentability of the predictable variation. Likewise, if a technique has

been used to improve one device, and a person of ordinary skill in the art would recognize

that it would improve similar devices in the same way, using the technique is obvious. KSR,

127 S. Ct. at 1740. In conducting an obviousness analysis, the court need not seek out 15

precise teachings directed to the specific subject matter of the challenged claim, but rather a

court can take into account the inferences and creative steps that a person of ordinary skill

would employ. Id. at 1741.

3. Prior User Right

35 U.S.C. § 273 states: 20

(a) A person shall be entitled to a defense under section 282(b) with respect to subject

matter consisting of a process, or consisting of a machine, manufacture, or

composition of matter used in a manufacturing or other commercial process, that

would otherwise infringe a claimed invention being asserted against the person if—

(1) such person, acting in good faith, commercially used the subject matter in the 25

ROBERT A. MILLER

49

United States, either in connection with an internal commercial use or an actual arm's

length sale or other arm's length commercial transfer of a useful end result of such

commercial use; and (2) such commercial use occurred at least 1 year before the

earlier of . . . the effective filing date of the claimed invention; …

(4) ABANDONMENT OF USE.—A person who has abandoned commercial use 5

(that qualifies under this section) of subject matter may not rely on activities

performed before the date of such abandonment in establishing a defense under this

section with respect to actions taken on or after the date of such abandonment.

An otherwise infringing party shall not be liable if the commercial use of the produce

occurred more than one year before the filing date of the patent. Even if Benson BOS-10 10

oxygenator is infringing on the ‘264 patent, Benson has made and sold the oxygenator with

special tubings which has the same feature to BOS-10 that being alleged infringing on the

‘264 patent claims, to Cornell University as early as April (YR-10). Therefore Benson is

qualified for the prior user right and is not liable.

15

ROBERT A. MILLER

50

Shine v. Benson

Deposition Summaries

Table of Contents 5

Robert A. Miller .......................................................................................................................54

Robert A. Miller is Shine’s Markman hearing witness. He is an experienced

perfusionist who explains blood oxygenators and heat exchangers. He also compares

the Shine S-100 and the Benson BOS-10. If this witness is played by a female, she 10

should be called Roberta Miller.

John E. (“Ted”) Lewin .............................................................................................................. 68

John Lewin is Shine’s witness. He is the inventor of the Shine S-100 oxygenator as

well as the ‘264 patent. If this witness is played by a female, she should be called 15

Jane Lewin.

Robert Curtis ............................................................................................................................ 88

Robert Curtis is Shine’s expert witness on infringement. He is the Senior V.P. of

Shine with responsibility for blood oxygenators. Commencing at page 89, Curtis 20

testifies to infringement. If this witness is played by a female, she should be called

Rita Curtis.

Donald Benson ........................................................................................................................ 100

Donald Benson is Benson’s witness. He is the retired CEO of Benson Laboratories 25

who testifies on infringement issues, see especially pages 105-106. If this witness is

played by a female, she should be called Donna Benson.

Dr. Frank Gollan .................................................................................................................... 117

Dr. Frank Gollan is Benson’s expert witness on non-infringement. He is the inventor 30

of prior art which is relevant to the trial issues only as to limiting the doctrine of

equivalents infringement theory. Note: the invalidity defense is not on trial. If this

witness is played by a female, she should be called Dr. Francis Gollan.

35

40

ROBERT A. MILLER

51

DEPOSITION SUMMARY OF ROBERT A. MILLER

My name is Robert A. Miller. I’m a perfusionist. I work at Mount Sinai Hospital in

New York City where I am the chief perfusionist. I have been a perfusionist for

approximately 25 years. My main responsibilities are to see that the operations of the heart-5

lung machine and perfusion are conducted in a precise manner during surgery. Perfusion is

the process of pumping blood through the patient’s body so that his or her organs are

supplied with blood.

I have an Associate or two year degree in zoology from Cerritos College in California.

I attended the University of California at Berkeley but I do not have a degree from that 10

school.

I am a member and Fellow of the American Society of Extracorporeal Technology. I

am also a member of the New York Academy of Sciences, the Association for the

Advancement of Medical Instrumentation and the American Association for the

Advancement of Sciences. 15

Extracorporeal technology is merely a term describing a technology that is involved

with devices and applications outside the body, an oxygenator, for example. An artificial

oxygenator is a device that is used and located outside of the patient’s body rather than inside

the body, so it’s referred to as an extracorporeal device.

Within the American Society of Extracorporeal Technology, which is commonly 20

referred to as AMSECT, I’ve held many positions. In May of this year I just concluded a

one-year term as president of that organization. Prior to that, I spent a one-year period as

president-elect, three years as treasurer, and about four years as a member of the Board of

Directors.

ROBERT A. MILLER

52

I am certified to practice cardiovascular perfusion. Certification is a rigorous

examination process that is administered by the American Board of Cardiovascular Perfusion.

Each individual, once he or she has been certified, is required to submit to the Board a yearly

statement as to his or her activities in order to maintain an active certification.

Presently I am a consultant to Galen Laboratories. I am involved in a project 5

involving laboratory evaluation of one of Galen’s devices. I have been a consultant to Galen

for about six years. I have also consulted for Cobe Laboratories, Shine, Inc. and Sterile

Design.

I’ve served as a consultant for Shine on many occasions, in a couple of different

capacities. I frequently provide educational training programs for Shine’s sales and technical 10

staff for the purpose of explaining the theory of perfusion so that they can better understand

their products and the integration of those products into the field. I have also provided for

them a service of discussing their products and their product performance with their

colleagues around the country who have questions about performance.

The circulatory system basically works like this. First, the heart pumps blood to the 15

lungs where carbon dioxide CO2 passes to the air in the lungs and oxygen O2 pass from the

air into the blood. As the blood is circulated through the body the oxygen is used and is

replaced by carbon dioxide. The carbon dioxide laden blood then returns to the heart and

lungs to be replenished once again.

The blood oxygenator is used during open chest surgery to take the place of a 20

patient’s lungs. One of the functions of a blood oxygenator, by the nature of its name, is to

oxygenate the blood during surgery. In the course of cardiac surgery, it is necessary for us to

stop the heart and, therefore, the patient can no longer move blood through his or her lungs

ROBERT A. MILLER

53

and body because the heart is no longer beating. In many cases the vessels are clamped so

that the blood can’t get from the heart to other organs. So we have to do it artificially.

Exhibit 4 is a drawing of a patient in which bypass surgery is to be performed. A

cannula or tube is connected to the femoral vein. The cannula carries venous, non-

oxygenated blood out of the patient to the first chamber, the oxygenator. Oxygen is forced 5

under pressure into the chamber and is forced through a device that breaks up the oxygen gas

into small jets to produce bubbles. This device may be a plate with tiny holes in it or it can

be a sintered material. The bubbles then mix with the blood making blood foam. After the

blood is oxygenated, it goes into a defoaming device which converts the blood foam back

into a liquid. The liquid then goes into another chamber, the heat exchanger, which either 10

cools or heats the blood. The blood is then returned to a femoral artery in the patient through

another tube or cannula.

Heat exchangers are used in blood oxygenators to cool and heat the blood. It is

important to reduce the metabolism of the patient during surgery to reduce the rate at which

oxygen is used. The patient is cooled to a temperature lower than normal to reduce his or her 15

metabolism and maintained at that temperature by the heat exchanger in the oxygenator

during the operation. Just prior to completing surgery the patient is rewarmed to a

temperature near normal by the heat exchanger in the oxygenator.

Heat exchange can occur in a number of locations. It can occur in the oxygenating

column of the oxygenator or in the venous side of the patient before the blood enters into the 20

oxygenator. It also can occur after defoaming and before the blood is returned to the patient,

as in Exhibit 4.

ROBERT A. MILLER

54

The most commonly used heat exchangers at this time and for some time have been

located in the venous, or oxygenating, side of the oxygenator because it alleviates some of

the hazards that are associated with having a heat exchanger after the gas transfer step.

I have used almost every type of blood oxygenator that has ever been manufactured,

both commercial models and homemade models. In the early days of perfusion, every 5

institution involved in chest surgery tried to make their own oxygenator, including those

which I personally was involved in making in the period (YR-25) to (YR-20). In the early

(YR-15)’s the oxygenators commonly available were the Travenol oxygenator, the Benson

Q-series, the Harvey and Galen. I am familiar with all of these oxygenators.

Both the gas transfer and heat exchange of an oxygenator can be rated by its 10

“performance factor.” This factor can be calculated in several ways. In the operating room,

one tends to look at the rate at which you are able to cool and rewarm a patient, but this

allows several variables to enter into the picture. Another way of looking at performance

factor is the temperature of the blood entering the oxygenator versus the temperature of the

blood as it leaves, having passed across the heat exchanger. This temperature is compared 15

with the difference in temperature between the cooling fluid, i.e. water, as it enters the heat

exchanger and leaves the heat exchanger. This performance factor tends to isolate many

variables and allows a more accurate assessment of the true performance of the device.

I have compared in Exhibit 8 the performance factors of six oxygenators available

during (YR-15) to (YR-6), i.e. the Shine S-100, Harvey H-1000, Sarns 65ML, Galen P5, 20

Travenol MO335 and Benson Q-100. It shows the performance factor, or percentage

efficiency factor, versus the rate of blood flow, or how fast blood is flowing through the

device. The higher the performance factor, the more efficient the device is in changing the

ROBERT A. MILLER

55

temperature of blood that is passing through it. It shows that as the rate of blood flow

through the device increases, the performance factor decreases because the amount of time

that the blood is exposed to the heat exchanger is decreased. The Shine S-100 had a far

better performance factor than the Benson Q-100 oxygenator.

The Benson Q-series oxygenator referred to in Exhibit 8 was used extensively 15 to 5

20 years ago by many hospitals. It was a disposable oxygenator where the heat exchanger

was located on the arterial side of the oxygenator, i.e. after the blood had been oxygenated

and defoamed. I have used the Q-series oxygenator several hundred times.

The Q-series oxygenator had several drawbacks. First, the arterial heat exchanger

was very inefficient. It took approximately four to six minutes to change the temperature of 10

the patient by one degree. Second, having the heat exchanger on the arterial side posed a

hazard. If you had to cool the patient to a very low temperature, the possibility of gas emboli,

or a gas bubble, escaping and going to the patient could be very harmful. Third, it had a poor

gas-to-blood flow ratio. I told Benson about the problems with the Q-series oxygenator, but

they did not do anything about them. After the Galen oxygenator came on the market I 15

switched to that oxygenator.

The longer you have to stay on the heart-lung machine, the more hazardous it is to the

patient. There are more chances for things to go wrong during the procedure or for the

device to fail, and there is more damage to the patient’s blood. Thus, we make every effort

to get the patient off of artificial support as soon as possible. To do this, we need to be able 20

to cool and rewarm the blood as quickly as possible.

An oxygenator should have smooth surfaces over which the blood flows. The red

blood cell is very delicate and can be damaged quite easily. If these cells are damaged it is

ROBERT A. MILLER

56

called hemolysis. A common cause of hemolysis is turbulence in the flow of blood in an

oxygenator. Hemolysis can occur by exposing the cells to a rough surface if the velocity of

the cells across the surface is sufficiently high. Even a surface that seems smooth to the eye,

but in fact has microscopic indentations, can cause this sort of damage. If enough red blood

cells are damaged, the patient will not be able to get a sufficient amount of oxygen or expel a 5

sufficient amount of carbon dioxide and will die.

Although you want a smooth surface for the blood to flow over, glass is not

necessarily smooth and is not a desirable surface for an oxygenator for several reasons. First,

surface roughness in glass can cause blood cells to break. Second, certain elements in blood

attach to glass, such as platelets and proteins. Third, a glass oxygenator is fragile and if it 10

breaks during the procedure the patient’s life may be lost. I do not know of anyone who has

used a glass oxygenator for open heart surgery.

I have used the Shine S-100 oxygenator about 500 times. I have used the Benson

BOS-10 oxygenator about 50 times. I find the Shine S-100 to be highly efficient in terms of

both gas transfer and heat exchange and to be extremely efficient, safe and easy to use in 15

support of my patients. It has better heat exchange performance than the other devices that I

previously had been using, i.e. it is able to heat and cool the temperature of a patient’s blood

in a shorter amount of time. In addition it provides good gas transfer of oxygen into the

blood.

Exhibit 7 is a drawing of the Shine S-100. This device closely resembles Figure 3 of 20

the ‘264 patent, Exhibit 2C. In Exhibit 7, oxygen gas enters through inlet port A and is

passed through the bubbling device which can’t be seen. Venous blood from the patient is

fed through port B and mixes with the oxygen in chamber C. The oxygenated blood rises

ROBERT A. MILLER

57

through the oxygenator, coming in contact with heat exchanger coil D. The blood swirls

around the channels in coil D and exits at the top of the oxygenator where it is then fed to

defoamer E. Cold water is input to the heat exchange coil at port F at the top and exits at port

G at the bottom.

In Exhibit 2C venous blood, i.e. blood in the patient’s body returning to the heart, is 5

siphoned by gravity into chamber 115 of the oxygenator through tube 121. Oxygen is fed

through a tube 125 into a sparger 127 which generates oxygen bubbles. The oxygen bubbles

then flow into chamber 115 where they mix with the blood, generating a foam. The foam

passes through a sponge 109 that has multiple holes. The foam then ascends up into chamber

70, flowing over and around coil 87. Coil 87 is about five feet, four inches long when 10

stretched out completely. It has a circumference of about three inches, and is wrapped

around an internal plastic column 90.

In chamber 70 the blood foam travels in multiple paths through the channels formed

by the ribs in coil 87. Cold water flows through the inside of coil 87, producing a heat

exchange which lowers the temperature of the blood foam. The blood foam, which is 15

oxygenated and at lower temperature, exits at the top of chamber 105.

The foam exiting at the top of the S-100 flows into a channel 35. From there it goes to

a defoamer chamber 37 where it is changed back to a liquid. It then goes to a reservoir

before being pumped back to the patient’s body. Defoaming is done by a sponge made of

nylon or tricot material through which the blood flows. 20

A photograph of the Benson BOS-10 oxygenator is shown in Exhibit 6A. In this unit

oxygen is delivered through an inlet port into chamber. The oxygen passes through a

perforated bubble forming disk. Venous blood is input through a nozzle positioned at the

ROBERT A. MILLER

58

back of the device. The blood and oxygen bubbles mix in the oxygenating chamber, forming

blood foam. The blood foam goes through a channel into the heat exchange chamber, where

it flows over the heat exchange coil. This coil, as shown at the middle of this drawing, has a

helical rib around the coil. The blood foam emerges at the bottom of the chamber and passes

through mesh screen into a defoamer, where it is liquefied. The liquid blood then exits the 5

device through another chamber and two ports.

Water for the heat exchanger is input through one port at the top back of the Benson

BOS-10, and passes through the coil. The coil passes into the center column at the bottom of

the heat exchange chamber and then this coil returns to the top of the device through this

column before exiting from a second port, also at the back of this drawing. There is also a 10

port at the top for inputting drugs into the blood. The coil is in contact with the outer wall

and inner wall of the oxygenating chamber.

The Benson BOS-10 differs in only a few respects from the Shine S-100. One

difference is that the circumference of the coil in the BOS-10 is approximately four inches as

opposed to three inches in the Shine S-100. Another difference is that the BOS-10 coil is 15

approximately six feet long when stretched out, as compared with five feet, four inches in the

S-100. A third difference is that the blood foam in the BOS-10 cascades down the internal

chamber, rather than rising up the chamber as in the S-100. However, the foam is agitated in

the very same manner as in the Shine S-100. A fourth difference is that defoaming is done in

a separate device in the Shine system while defoaming in the BOS-10 is done in the same 20

container. To me, the Benson and the Shine oxygenators are identical because I use them

both on my patients routinely, day in and day out.

ROBERT A. MILLER

59

Bubble oxygenators, such as the Shine S-100 and the BOS-10, have several

advantages over oxygenators available previously. First, these oxygenators allow efficient

transfer of heat from the blood to the heat transfer fluid. This is important because the

quicker the blood is cooled and rewarmed, the less time the patient has to be connected to the

extracorporeal blood circuit. It is a well-known fact that the longer someone is hooked to a 5

blood oxygenator or heart-lung machine, the more at risk they are of having problems in the

post-operative period.

Second, these oxygenators provide a number of continuous and restricted area flow

paths for the blood. This means there are many paths for the blood to go up and down. Thus,

the resistance to blood flow is low in the heat exchanger. The blood comes into the chamber 10

and follows the coil ribs. As a result, the blood has a long residence time in the heat

exchanger which helps the heat exchange in the oxygenation process.

Third, the heat transfer fluid tube in the oxygenator has hollow ribs which provide

substantial area for transferring heat or cold to the blood. Twisting the tubes provides

increased surface area. 15

Fourth, heat transfer is optimized by the counter-flow manner of exchanging heat

between the blood and heat transfer fluids. In other words, this device is designed to have

the cooling water and the blood flowing in opposite directions, which is the most efficient

way to transfer heat.

Fifth, the coated aluminum tubes are very thin, thereby facilitating heat transfer, yet 20

are strong enough to prevent structural problems. Even through the polyurethane coating

reduces thermal conductivity of the aluminum tube by some 15%, the coated aluminum tubes

in these oxygenators still have high thermal conductivity.

ROBERT A. MILLER

60

Sixth, the helically ribbed heat exchanger tube has a sufficiently large diameter so

that the heat transfer fluid can flow at a high rate. For example, a 1/2 inch diameter tube

allows 21 liters of water per minute to flow.

Finally, the helically ribbed exchanger tube in combination with the inner and outer

wall surfaces of the blood chamber contribute to additional oxygen transfer to the blood and 5

carbon dioxide removal from the blood.

61

DEPOSITION SUMMARY OF JOHN E. LEWIN

My name is John E. Lewin. I live in Marco Island, Florida. I am employed by Shine,

Inc. where I am a Senior Project Engineer. I am the inventor of Patent No. 4,065,264.

I have a degree in Power Plant Engineering Design from Drexel Institute of 5

Technology, Philadelphia, PA. In addition, I have attended U.C.L.A. evening school taking

courses in aerodynamics, fluid mechanics, the flow of fluids, and specification writing.

Following high school I worked as a machinist for a corporation which built large

naval ships. I worked on a large heat exchanger - a condenser, with straight tubes that run

through the condenser from one end to the other allowing sea water to pass through the tubes. 10

As steam was exhausted from the steam turbine which ran the ship, it was cooled by the heat

exchanger and condensed back into boiler water.

During (YR-39) through (YR-36), I was an engineer in the Merchant Marine. I

operated the propulsion system and heat exchangers for Merchant Marine ships. After that, I

worked for several companies in the East, designing large power plants, heat exchangers, 15

pumps, and engines.

In (YR-34) I moved to California to work for North American Aviation, which later

became North American Rockwell. Originally I was a design engineer working on the F-86

and F-100 aircraft. Later I became a design supervisor in the X-15 program and the Apollo

program. Again, I was in charge of designing the propulsion systems including heat 20

exchangers. I worked for North American for 24 years.

I took early retirement from North American and joined Shine in February (YR-10).

JOHN E. LEWIN

62

Before I was hired at Shine another of its engineers, John Marks, had designed and

built a prototype blood oxygenator. When I arrived at Shine, I was given that prototype and

was assigned the task of designing a heat exchanger that could be used in combination with

this blood oxygenator. The prototype at the time did not include a heat exchanger. Shine

had not done any work on the heat exchanger. 5

A blood oxygenator is a device used during surgery, such as open heart surgery,

where it is necessary to circulate the patient’s blood outside his or her body and to perform

the function normally performed by the patient’s lungs, that is to add oxygen to the blood and

remove the carbon dioxide from the blood. An important component in such a system is a

heat exchanger used to lower blood temperature prior to and during surgery and to re-warm 10

the blood to normal body temperature after surgery. It is important to cool the blood before

and during surgery because the cooler blood substantially reduces the amount of oxygen that

the patient consumes in order to maintain basic body functions. Cooling the blood protects

the vital organs including the kidneys, heart, brain and liver during operative procedures

which require interrupting or decreasing perfusion. 15

Before I started work at Shine, I had lots of experience in designing heat exchangers,

but no experience in the medical or biomedical field or with blood oxygenators.

When I arrived at Shine I reviewed documents and talked with the people who were

working on the oxygenator to find out what work they had done and what they were doing. I

also read material related to the medical field. I read journals and anything I could get my 20

hands on. I looked through trade publications, design magazines and all sorts of journals. I

studied up on the field.

JOHN E. LEWIN

63

I was given information about some of the bubble oxygenators then on the market. I

saw the Harvey unit, the Benson Q-series, and the Galen unit. I wanted to come up with a

better unit than any of them, and I believe I did.

Prior to my invention of the Shine S-100 oxygenator a number of different

configurations had been used by other companies in the artificial blood circuit. However, 5

there was a need for a more efficient heat exchanger design which would be simple to use

and yet inexpensive enough to be manufactured as a disposable item. It had to be disposable

in order to avoid blood contamination from one operation to the next.

I did not set out to design a heat exchanger like those previously used in blood

oxygenators. I wanted a better performance factor. Performance factor is a formula used 10

throughout the industry to evaluate the efficiency of various heat exchangers.

It was important that the heat exchanger have a high performance factor in order to

reduce to a minimum the time needed to lower blood temperature to the desired level and

subsequently raise it to normal. Some blood degradation occurs after a patient is connected

only a few hours to a bubble oxygenator. Therefore, time saved in cooling and rewarming 15

the blood is of direct benefit to the patient and also gives the surgeon additional time to

conduct the surgery.

The various problems I worked on included performance of the heat exchanger,

where we would locate it, whether it was to be disposable or reusable, and the types of

materials to use. 20

We had to decide whether the best heat exchanger should be metal or plastic or some

other material. It was still unresolved as to which materials were adequate, and whether they

JOHN E. LEWIN

64

were compatible with blood. That was a very important issue. Strength was also important.

Leakage from the coolant side of the heat exchanger to the blood side was not tolerable.

I never considered using glass for the heat exchanger. It never even entered my mind

because I would have thought glass would be unsafe in a device to be used with human

beings. I remember that my mother threw away a full jar of peanut butter because the jar was 5

cracked. The risk that a splinter of glass would get in the blood and cause injury caused me

to never consider glass.

In February (YR-10), I sat down and started to think about the type of heat exchanger

configuration I wanted to concentrate on. From my past experience with heat exchangers, I

thought of heat exchangers in classic configurations such as smooth tubes wrapped in a coil 10

or straight tubes in a nest. I came up with several configurations which I put down on paper.

I purchased some smooth surfaced aluminum tubing and formed it into coils of

different diameters. I chose aluminum because copper is toxic to blood. Even though

aluminum is not safe for blood, it is not as bad as copper. I built a number of prototypes with

smooth tubing formed in a coil. I also built a unit with straight tubes which we affectionately 15

called “Big Bertha.” It was much like the big heat exchangers I had previous experience

with in ship building. None of the prototypes seemed likely to give me the performance I

wanted or the producibility.

Shortly after joining Shine in early (YR-10) I saw an advertisement (Exhibit 9) in a

mechanical engineering journal showing a twisted spiral tube called “Turbotec.” The ad was 20

from a company called Spiral Tubing. This ad says that the Turbotec tubing had more

surface area and spells out the various advantages it might offer for a heat exchanger. It also

mentioned that Turbotec would bend very easily like a rope.

JOHN E. LEWIN

65

I called Spiral Tubing and they sent me a sample of this spiral tubing. It was a

straight piece of tubing but was twisted about its length to make spiral ribs. I took a plastic

cylinder and wrapped the tubing around the cylinder by hand. I was able to wrap it, and

straighten it out again without any kinks. I then decided to try it in some of the design

configurations for the heat exchanger in which I had already started using smooth tubes. I 5

contacted Spiral Tubing again and asked them to fabricate the spiral tubing in some of the

coil configurations I had designed.

Spiral Tubing had to specially construct the coils which I ordered because coils were

not a stock item with them. The tubing was a stock item, but the coil was not. The first

Turbotec tubing coils I had made used 3/8” diameter tubing. I tried it in several different coil 10

diameters. I also used some straight lengths of tubing in a nest.

When I received the Turbotec coils I installed them in some plastic housings, glued

them together and took them up to our engineering test lab. I ran some tests using water

where the blood would normally be. We also used water in the tube as the cooling agent.

As we tried to increase the water flow rate through the tubes, the back pressure got so 15

great that it blew the connector and caps off the tubing and made a terrible mess. Water flew

all over the place. People got wet and all of the lab instruments got wet. People in the

laboratory as well as my engineering colleagues told me I was crazy, that I should abandon

the idea right then. However, I wanted to go on, so I redesigned some more coil

configurations using 1/2” tubing instead of 3/8” tubing. I calculated the surface areas I 20

wanted to achieve, as determined by the length of tube and the number of ribs, etc.

I purchased some 1/2” Turbotec coils. I built the coils into some model test rigs

simulating the oxygenator, bonded the ends together, put connectors on and ran the same

JOHN E. LEWIN

66

type of water test we ran before. Unfortunately, the back pressure again blew the connectors

and end caps off. I created another mess in the laboratory and got a lot of people wet.

People in the laboratory as well as my engineering colleagues continued to try to discourage

me.

In the Fall of (YR-10) I met with management for a design review. There were many 5

skeptics among management because of the blow-ups I had in the laboratory and also

because it was generally accepted that blood should have a smooth surface to flow over. I

was told that blood can be damaged very easily and there was a danger of damaging it if it

flowed against the ribs on these coils. However, management decided to let me go forward

with my experiments. 10

I then ordered some 3/4” diameter Turbotec tubing coils. When I received them I

discovered that they were too large to fit in the oxygenator we had designed, so we had to

redesign the plastic housing. We did that and then ran some tests. For the first time the test

with the 3/4” tube showed the ability to handle the flow. We also tested the heat transfer and

found the performance factor was very good. 15

We were very surprised to find another benefit when we tested the device with blood

and oxygen. We got a much better than expected gas transfer. Apparently, the slow

tumbling and gentle flowing of the blood mixing with the oxygen gave us unexpectedly good

gas transfer. This was a beautiful surprise and was an added bonus to the design. That was

in December (YR-10). 20

We then began designing a production model of the heat exchanger in combination

with the rest of the blood oxygenator in which the heat exchanger would be used. As Spiral

Tubing’s experience was only with straight lengths of its twisted tubing, I had to decide on

JOHN E. LEWIN

67

the diameter of the coil. I also had to decide on the number of helical twists I wanted on the

tubing. In other words, I had to tell Spiral Tubing how to make the tubing and how to make

the coils.

We spent the rest of the spring of (YR-9) refining the design of the combination of

the heat exchanger with the oxygenator and doing a lot more testing. We were testing with 5

blood at that time.

I was aware before I ordered the Turbotec aluminum tubing that it would have to be

coated if it were to be used in an oxygenator. Aluminum was known to be poisonous to

blood, causing blood to clot. Thus, after I had satisfied myself that the coiled aluminum

tubing would work as a heat exchanger, I had to decide how to protect the aluminum from 10

damaging the blood. I decided to coat the aluminum with polyurethane, which I knew was

compatible with blood. I was told polyurethane coating had been used on aluminum. I

believe the Harvey device had its heat exchange tubes coated with polyurethane. However,

that was a smooth aluminum surface and was nothing like the configuration we were going to

have to coat. I was not sure that we could adequately coat the Turbotec coil and neither was 15

Spiral Tubing. The coating process was difficult because it is hard to get a uniform coating

on a tube which is twisted like the tube we were using. After much trial and error we were

able to get a consistent, satisfactory coating.

After the design was completed we had to test it first on animals and then conduct

clinical tests on human beings. Sometime in the Spring of (YR-9) we decided we had a 20

satisfactory design for the bubble oxygenator. We decided it was better and safer than

anything on the market. The performance factor of the heat exchanger was better than any

heat exchanger in a competitive blood oxygenator. We designated the device the Model S-

JOHN E. LEWIN

68

100 and placed it on the market in mid-(YR-8). Exhibit 7 is a drawing of the S-100

oxygenator.

I would estimate that I worked about 3,500 hours to develop the Shine S-100. In

addition, I would estimate that there were at least 1,000 hours of laboratory technician’s time

and at least 1,000 hours of a prototype technician’s time, as well as the time spent on test 5

marketing the final design in late (YR-9).

Referring to Figure 3 of my patent, Exhibit 2C, the Shine S-100 blood oxygenator is

shown in cross section. It includes an outer plastic shell 80. Blood from the patient comes

into the blood oxygenator through a tube 121 at the bottom of the shell. Oxygen also is fed

into the blood oxygenator through a tube 125 at the bottom of the shell. The oxygen coming 10

out of the tube is formed into bubbles by passing through a sparger 127. Those oxygen

bubbles mix with the blood and form a blood foam as they pass through the oxygenator. A

sponge 109 aids in mixing the oxygen and the blood as it enters the oxygenation chamber.

The use of a sponge was not my idea. The blood and oxygen together pass up through the

shell and come out the top into conduit 35. From there they go to a defoamer where the 15

blood foam is converted back to liquid. The liquid blood then goes to a reservoir from which

it is pumped back to the patient.

As the mixture of blood and oxygen flows upwardly through the housing it comes

into contact with a heat exchanger which either cools or heats the blood, depending on how it

is being operated at the time. The heat exchanger is a long tube 87 which is wrapped 20

helically around a cylindrical column 90 mounted in the middle of the blood oxygenator. The

heat exchanger tube 87 is a hollow tube. Water passes through the tube from the top to the

bottom, entering at 81 and leaving at 85. If it is necessary to cool the blood, as is done before

JOHN E. LEWIN

69

and during surgery, cold water is passed through the heat exchange tube. If it is necessary to

re-warm the blood, as is done after surgery, hot water is passed through the heat exchanger

tube.

The heat exchanger tube used in my blood oxygenator is quite different from the heat

exchanger tube used in previous blood oxygenators. You can see from Exhibit 2C and 7 that 5

the tube is wound around the center column in a helical configuration, and the tube itself also

includes helical ribs which extend helically around the length of the tube. The space between

the center column and the shell is about the same size as the diameter of the ribs of the tube

so that the heat exchanger tube with its ribs fits quite closely into that space. Therefore, as

the blood and oxygen mixture moves upwardly through the shell it comes into contact with 10

the tubes.

The helical ribs force the blood to swirl around the tube in a helical path rather than

just going straight through the shell. Where the gap is very small the flow tends to go inward,

upward and swirl. The flow substantially covers the entire surface of the heat exchanger with

a very long residence time from the bottom of the unit to the top. The combination of the 15

ribs on the tubes, the outer shell and the wall of the column provide a number of continuous

restricted area flow paths which cause the blood and oxygen mixture to have a long residence

time in the heat exchanger. The structure also avoids areas of stagnation which would

otherwise hinder heat transfer from the blood because the swirling action caused by the

restricted flow paths keeps the blood and blood foam in constant circulation throughout the 20

paths. Tests show that a substantial portion of the blood and blood foam appear to actually

follow the helical paths around the heat exchanger tubes, thus achieving extensive contact

with the heat exchanger tube over a long period of time.

JOHN E. LEWIN

70

The ‘264 patent refers to “restricted flow paths.” That means a diversion of flow.

“Shunting” on the other hand is directing a fluid around a restriction so it will not be

restricted. I avoided shunting in my patent and instead used restricted flow paths. The ‘264

patent states that the continuous helical flute passage is considerably longer than the length of

the tube. That means if you took the coil and straightened it out to its full length the helical 5

flute passage is considerably longer than the tube. I cannot tell you how much longer the

patent means but it must be long enough to accomplish the job of providing the desired

performance factor and gas transfer.

I have always tried to maintain the helical rib on the tubing close to the container wall.

I have never tested any part with a large gap. The exact dimension of the gap is not the 10

important thing so long as the helical ribbed coil is close to the container wall. That gives

excellent heat transfer performance as well as great gas transfer.

I do not know how wide that gap can be before the results would fall off. As the gap

is widened, the performance factor at some point will fall off and you will not get the same

result as the patent. The gap, as calculated from the production drawings and their tolerances, 15

is about 0.00675 inches. I have never measured the gap in Benson’s BOS-10 oxygenator.

Exhibit 8 is a chart comparing the performance factors of various heat exchangers

including the Shine S-100 and some of the other competitive heat exchangers on the market

at the time of my invention. I assisted in preparing this chart. I reviewed reports from

various competitor companies to verify the performance factors that we put in that exhibit. 20

The data reported for the Shine S-100 was prepared under my direction. The report

accurately reflects the performance factor data for the Harvey H-1000, Sarns 65 ML, Galen

PS, Travenol M0335 and Benson Q-100 oxygenator.

JOHN E. LEWIN

71

The top curve represents the performance factor for the Shine S-100. The bottom

curve represents the performance factor for the Benson Q-100 oxygenator.

In addition to providing a highly efficient heat exchanger the helically ribbed tube

together with the inner and outer wall surfaces of the blood chamber increase mixing of the

oxygen and removal of carbon dioxide from the blood. 5

The prototype that Marks had made before I began my work at Shine differed

substantially from the device shown in Figure 3 of my patent. It did not have the coil in it. It

also differed in diameter and length. It did have an inlet for blood, an outlet for blood, an

inlet for gas and an outlet for gas. However, they were configured differently than the

oxygenator in my patent. 10

I was involved in changing the shape of the oxygenator chamber and the bubble

column to accommodate the heat exchanger I had designed. There was a lot of design work

involved in making the combination of the heat exchanger with the rest of the oxygenator.

The prototype had a central column and an outer casing spaced from the central column. I

never tried to put the coil I obtained from Turbotec in that prototype. 15

After the development work was done, I decided it would be good to talk to our

patent attorney about obtaining a patent to protect my idea and all of the hard work we had

done and to protect Shine for their investment. A patent was issued by the United States

Patent Office for my blood oxygenator on December 27, (YR-8). Exhibit 2 (pages A-L) is a

copy of the official patent I received from the Patent Office. 20

After my patent issued, I was asked to submit the Shine S-100 oxygenator to the

Patent Office for a display for the National Inventor’s Day Exposition. On National

Inventor’s Day certain patents are put on display at the Patent Office.

JOHN E. LEWIN

72

The Turbotec ad, Exhibit 9, makes no reference to blood oxygenators. Turbotec told

me that this would be a new application for spiral tubing. This ad states in the third

paragraph that the Turbotec tubing was “currently applied in biomedical devices like

artificial kidney machines and artificial hearts.” That did not, however, suggest to me that

this would be an appropriate coil for use in a blood oxygenator. Turbotec informed me that 5

these parts had never been in contact with blood.

Exhibit 9 also states in the first paragraph that “in some cases swirl-generating inserts

in piping creates fluid turbulence and increases the piping’s heat transfer capability.” That

suggested to me that the configuration would increase heat transfer capability, but I do not

believe everything I read in advertisements and had to prove it to myself. 10

Exhibit 10A and B are the cover and copyright page for a book entitled Physiology of

Cardiac Surgery, by Dr. Frank Gollan. Figure 9 (Exhibits 10C and 10D) appears to have a

diagram and a photograph of a glass micro-bubble oxygenator. The diagram (Exhibit 10C)

and the photograph (Exhibit 10D) suggest to me that coil tubing could be applied to an

oxygenator. Exhibit 10C appears to show a smooth cooling tube and does not show the kind 15

of spiral tubing I got from Turbotec. I cannot tell what kind of tubing is used in Exhibit 10D,

except it appears to be made of glass.

I have never seen, tested, designed or used a glass oxygenator in my laboratory. The

reason for never designing or building a glass oxygenator is because glass tends to be bad for

blood. If blood is exposed to glass it causes it to clot sooner as opposed to most other 20

materials used in an oxygenator. Because of this and because glass is breakable, we chose

not to use it. If blood is damaged sufficiently during bypass surgery, it could cause the

patient to bleed excessively after the operation and lead to death. The tubing in Exhibit 10C

JOHN E. LEWIN

73

does not have a helical flute passage which is considerably longer than the length of the tube,

as found in the Turbotec tubing. I cannot give you a precise definition of what “considerably

longer than the length of said fluid conduit” means, but it means a lot longer than the tube. I

cannot tell from the photograph of Exhibit 10D whether the glass tubing is ribbed.

Exhibit 11 contains an excerpt from a book entitled Heart-Lung Bypass by Pierre M. 5

Galletti, published in (YR-23). Chapter 3 entitled “Material Used in Extracorporeal Circuits”

describes state-of-the-art materials used in extracorporeal circuits. This chapter also

describes the effects that different materials have on blood. Normally, materials that are

exposed to blood are smooth. This is done to keep the blood and blood cells from getting

damaged. The material that the blood sees should be very smooth without major undulations. 10

The significance of this is to avoid deposition of fibrin, which is a protein involved in the

clotting of blood. The blood would then tend to clot and create a rough surface.

My helically ribbed, helically fluted coil is different than the heat exchangers

depicted in Dr. Gollan’s book. My coil, with its peaks and valleys, appears at first blush to

be damaging to blood. Those things may induce local turbulence. This is just the opposite of 15

what is shown in Dr. Gollan’s book.

Comparing my helically ribbed heat exchanger to heat exchangers then available on

the market reveals the differences in approach. For example, the Harvey unit had multiple

parallel smooth tubes and the Benson Q series had a tin can with a very smooth coating on it

without local turbulence. Thus, I went against the suggestions of those prior art oxygenators. 20

The diameter of the Benson BOS-10 coil is different from that of the coil in the Shine

S-100. There are a different number of coils and the lengths of the coils are different. I do

not know whether the number of ribs is the same.

JOHN E. LEWIN

74

75

DEPOSITION SUMMARY OF ROBERT CURTIS

My name is Robert Curtis. I graduated from high school in Compton, California and

then went to a two-year community college called Chaffey College in Alta Loma, California.

From there I transferred to the University of California at Berkeley and graduated in (YR-18) 5

with a Bachelors degree in Chemical Engineering. I went back to Berkeley to obtain my

masters degree in Mechanical Engineering in (YR-15). During my Masters program I took

several courses in biomedical engineering. These courses are directed to enabling engineers

to collaborate with doctors for the purpose of improving medical equipment.

My first job out of college was as a process engineer at Stauffer Chemical Company, 10

located in the Bay Area in San Francisco. I then took a part time job when I decided to go

back to school, at the U.S. Department of Agriculture Western Research Laboratory in

Albany, California. There I was a research engineer working on methods to preserve blood

outside the body for reintroduction into the body. I then went on to another part time job at

Pacific Medical center Presbyterian Hospital in San Francisco as a research engineer. In 15

(YR-15) I began working full time at Presbyterian Hospital.

As a research engineer I was involved in a project to improve the performance of a

membrane blood oxygenator. A membrane oxygenator oxygenates the blood by the use of a

membrane. It’s like a “baggy” or a sheet of plastic between the blood and the gas. The

difference between the membrane oxygenator and a bubble oxygenator is simply that the 20

bubble oxygenator bubbles gas directly into the blood. I have authored several papers on the

subject of blood oxygenators. I believe the first paper was written in (YR-15) and the last

paper was written three or four months ago regarding biological heat transfer and biological

systems.

ROBERT CURTIS

76

I’m a member of several professional societies, including the Association for the

Advancement of Medical Instrumentation (AAMI). Blood Oxygenators Standards

Committee (BOSC) is a subcommittee within the AAMI, of which I am also a member.

BOSC’s function is to standardize some of the techniques and procedures used with

oxygenators. I am also a member of the International Standards Organization Blood 5

Oxygenation Committee. Its function is similar to BOSC in the United States, but on an

international basis. I am also a member of the American Society for Artificial Internal

Organs. This is an organization where people get together to communicate about artificial

organs i.e., artificial kidneys, machines, artificial hearts, blood oxygenators, or anything

relating to diabetes. I am also a member of the European Society for Artificial Internal 10

Organs. This organization is similar to the others but located in Europe. I attend one or two

meetings per year to keep abreast of the state of the art.

I have been called on several times to lecture on blood oxygenators. One such group

is called AMSET, the American Society for Extracorporeal Technology. The purpose of

these lectures is to give information on heat exchange and gas transfer of oxygenators. 15

I currently work at Shine, Inc. I joined Shine on April (YR-11) where I was called

Project Engineer working on the blood oxygenator. When I first joined the company my sole

responsibility was the bubble blood oxygenator program. At the time, Shine’s main products

were artificial heart valves which were sold to cardiovascular surgeons. We talked to these

surgeons and they informed us about the oxygenators then available on the market and 20

explained that some improvements should be made, i.e., safety, time and efficiency. Based

on these conversations, a need for an improved oxygenator was established. At that time

ROBERT CURTIS

77

there were only two others working on the project with myself. My primary responsibility

was to review the literature and prototypes of oxygenators that I would eventually test.

Due to lack of equipment, I set up a laboratory myself and had to study elsewhere to

familiarize myself with the technology. I reviewed a large amount of literature, including

patents that were issued at the time. The purpose was to ensure that we develop our own 5

unique design that did not infringe upon someone else’s design. I studied several blood

oxygenators that were on the market, including some made by Benson, Harvey, Cobe and

Polysten. We took apart each oxygenator to learn how it worked.

After some time I was promoted to the position of Research Engineer but I continued

doing the same work. Two more people were added to work in my department. Within a 10

year I received another promotion to Project Research Manager. Several more people were

added to my department. Nearly all of my time was spent on the blood oxygenator program

during this period.

I was then promoted to the position of Project Manager of the blood oxygenator

project. I was in charge of the engineering research and development of the manufacturing 15

parts of the blood oxygenator project. Soon after that I was promoted to Manager of

Cardiopulmonary Systems with responsibility for Shine’s entire cardiopulmonary line. In

this position I would say that 50-75% of my time was spent on oxygenators. About a year

after that I was promoted to Director of Research and Development. My responsibility

included all of the oxygenators of the cardiopulmonary projects and some cardiovascular 20

projects.

ROBERT CURTIS

78

I was also responsible for being aware of competitor’s oxygenators. We have a

standard policy of obtaining samples of competitor’s products and testing them. We take

them apart, see how they are built, and determine whether any changes have been made.

My next position was Vice President of Research and Development. I was promoted

a year after that to Vice President and General Manager of the Surgical Projects Division of 5

the company. Soon after that I was promoted to Senior Vice President of Shine where I

currently maintain my responsibility and expertise regarding blood oxygenators that are

commercially on the market.

I have tested approximately 30 different types of commercial oxygenators during my

career. I have taken Benson’s BOS-10 oxygenator apart between 10 and 15 times. I am very 10

familiar with the way blood and oxygen mix and flow in the BOS-10 device.

Shine entered the blood oxygenator business because open heart surgeons needed an

improved product. Since Shine was already selling heart valves to surgeons, the company

felt it could benefit by selling oxygenators at the same time.

Team meetings are necessary for every project. We meet on a periodic basis. Within 15

these meetings, minutes are taken so that everyone knows what is going on. On February 3,

(YR-10), it was announced that Ted Lewin would begin work on the oxygenator project as a

Design Engineer. At this time we had developed several prototypes of oxygenators, some of

which had begun to oxygenate. Although the heat exchanger had not been addressed, we

were not sure if we wanted the heat exchanger to be part of the oxygenator or a separate unit. 20

Mr. Lewin’s responsibility would be to design the heat exchanger in or outside the

oxygenator.

ROBERT CURTIS

79

At the beginning of every project, goals are written down. Our number one goal for

this particular heat exchanger was to have it equivalent to or better than the Benson Q-100.

On Monday morning Ted brought in an advertisement about special tubing made by

Spiral Tubing Corporation called “Turbotec.” He ordered this tubing and several weeks later

samples arrived. He immediately began making prototypes of different models. In the 5

beginning I was skeptical. Ted performed many tests on the Turbotec tubing; testing to see

how it would break, how to make it bend, and how heat makes it change. Turbotec tubing is

made of aluminum.

Ted’s idea for the heat exchanger was quite different from exchangers in other blood

oxygenators in that Ted’s used Turbotec tubing. All of Ted’s heat exchangers had helically 10

ribbed tubes which wound into different configurations. Because the Turbotec tubing was

made of aluminum, it had to be coated. This was Ted’s idea. We initially tried paint, but this

did not work. The initial coating we used was polyurethane. Ted still did all the testing. He

anodized the aluminum coating by electrolytically processing the aluminum. This is an

extremely hard coating compared to the aluminum itself and it protects the coil from 15

oxidizing. The first Shine S-100 oxygenators had a polyurethane coating on them but later

models had an anodized coating.

The combination of elements defined in Claim 4 of the ‘264 patent is found in the

Benson BOS-10 oxygenator, as shown by comparing the claim chart (Exhibit 1) with the

photos of the Benson BOS-10 oxygenator (Exhibits 6A and 6B). 20

First, Claim 4 is a blood oxygenator having an integral heat exchanger for regulating

the temperature of blood in an extracorporeal circuit. The BOS-10 device is a blood

oxygenator with an integral heat exchanger.

ROBERT CURTIS

80

The next element in Claim 4 is an oxygenating chamber, which can be found near the

top of the BOS-10.

Claim 4 then recites a first means for introducing blood and bubbles of oxygen into

the oxygenating chamber for forming blood foam within the chamber. The oxygen inlet on

the BOS-10 passes oxygen through a perforated device which generates bubbles, and the 5

bubbles then mix with the blood, forming blood foam.

The next element in Claim 4 is second means for contributing to the transfer of

oxygen into the blood and carbon dioxide out of the blood and for regulating blood

temperature. The BOS-10 oxygenator has a helical heat transfer tube with a continuous

hollow rib along its length. If you took your finger, you’d be going around the helix and 10

would eventually come out at the other end of the tube. That’s a continuous hollow helical

rib. These ribs on the fluid conduit create a flute passage which can be followed around from

one end of the tube to the other.

The next element in Claim 4 is that the flute passage is considerably longer than the

length of the fluid conduit. This requirement is also satisfied by the BOS-10 oxygenator, 15

where the ribs create flute passage winds around the coil.

Claim 4 next states that the helical rib is located in contact with or closely proximate

to the inner wall of the oxygenating chamber. This is also found in the BOS-10 oxygenator,

where the tube is mounted between the inner wall and outer wall of the oxygenating chamber,

either touching it or almost touching it. 20

Claim 4 goes on to say that substantially all of the blood and blood foam flows in

contact with the external surface of the heat transfer conduit through a plurality of flow paths

of restricted area and extended length. As a result, the blood and blood foam have a long

ROBERT CURTIS

81

residence time in contact with the heat transfer conduit. This also occurs in the BOS-10

oxygenator consistent with Claim 4.

No specific dimensions are mentioned in Claim 4 – it states only that substantially all

of the blood flows over the conduit. The BOS-10 has been tested to determine whether or

not substantially all of the blood and blood foam flow in contact with external surfaces of the 5

heat transfer tube, and it does as it goes through the BOS-10’s oxygenating chamber. It does,

but is not a constant contact. When the blood or blood foam is not going over the coils, it

goes down the inner wall of the chamber or the center column and then spirals back over the

coils. If we saw a sheet of blood going to the outside, I would say the coil would not be

touching the chamber wall and substantially all the blood would not be flowing over the heat 10

exchange coil. We didn’t see such a sheet.

I conducted a test with the Benson BOS-10 and Shine S-100 oxygenators with

Professor George Wilson from the University of Florida and several lab technicians. The test

included taking the Shine S-100 device and mounting it next to a Benson BOS-10 device.

We raised the top portion of each oxygenator slightly and attached the defoamer in order to 15

observe the blood and the blood foam flowing over the coils through the plastic housing.

I observed that the blood and blood foam coming in at the top of the BOS-10 device

came down across the heat exchanger. The blood and blood foam flowed in a spiral fashion

downward. In the Shine device the blood and blood foam flowed upward over and around

the coils and off the inner wall of the chamber. The spiral flow patterns of the BOS-10 and 20

Shine 100 were nearly identical though in opposite directions. The Benson device had larger

bubbles of blood foam than the Shine device.

ROBERT CURTIS

82

The gaps of the BOS-10 and the Shine S-100 were measured at my direction under

close supervision at Shine. I did not do the measurements myself. I do not recall what the

precise measurements were but they showed that the gaps in the two devices were essentially

identical, no greater than an 1/8 inch difference between them. I also had the opportunity in

my work with Shine to disassemble the BOS-10 oxygenator and study it. This examination 5

showed that the heat exchanger ribs were close to the wall of the oxygenating chamber and

the wall of the center column.

Mid-(YR-8) was the first sell date of the S-100 oxygenator. Sometime between (YR-

11) and (YR-9) there was a great demand or need for blood oxygenators, in particular, for

disposable blood oxygenators with an integral heat exchanger that was more efficient than 10

those on the market at that time. There was also a need to reduce the amount of blood

damage caused by existing oxygenators. It was believed that blood damage was related to

the amount of gas flowing through the oxygenator itself. The Shine S-100 oxygenator solved

this problem by providing an integral heat exchanger in the oxygenating chamber with the

ability to cool or heat the blood during the oxygenation process thus requiring less oxygen 15

gas to be introduced into the oxygenating chamber due to greater oxygen absorption by the

blood during the oxygenation process. The Shine S-100 and Benson BOS-10 blood

oxygenators with their integral heat exchangers replaced the other oxygenators that had been

used prior to their development. This occurred because these devices had a much better gas-

to-blood flow ratio than the earlier devices and much better heat exchange characteristics 20

because of the long contact time between the blood and the heat exchanger.

There is no question that the Benson BOS-10 infringes Claim 4 of the ‘264 patent.

The BOS-10 contains each of the elements of Claim 4, and any differences, such as the small

ROBERT CURTIS

83

gap between the ribbed tubing and inner wall of the oxygenating chamber or the downward

blood flow of the BOS-10, are minor and insubstantial from Claim 4 of the ‘264 patent.

84

DEPOSITION SUMMARY OF DONALD BENSON

My name is Donald Benson. I founded and opened the doors of Benson Laboratories

on January 1, (YR-20). I worked there as Chief Executive Officer and Chairman of the

Board until (YR-5) at which time I retired. I am now a private investor. I serve on the Board 5

of Directors of several small start-up companies and am engaged in philanthropic work. I am

a member of the following organizations: The American Society for Mechanical Engineers,

the Health Industries Manufacturers Association and the Association for the Advancement of

Artificial and Internal Organs.

I studied mechanical engineering at the University of Arizona at Tucson. I then 10

received an appointment to the U.S. Naval Academy at Annapolis, Maryland and graduated

from the Academy in (YR-40) but was forced to leave the service because of an eye problem.

I then went into private business as an engineer. After graduation from the Naval Academy I

went to the Rucker Company as a Plant Manager and stayed there until (YR-23) when I took

the position of Vice President and General manager of Edwards Laboratories, the originator 15

of the first successful heart valve.

In (YR-22) Edwards Laboratories was approached by Dr. Richard A. DeWall who

was a well-known thoracic surgeon. Dr. DeWall, while a resident, had been assigned the

task of developing means to support a patient during open heart surgery. He accomplished

the objective and published a paper on the device that he came up with. This device was the 20

basis for the first disposable oxygenator that was sold in this country, which was sold by

Travenol Laboratories under a license from the University where Dr. DeWall had done the

work.

DONALD BENSON

85

Dr. DeWall was interested in making improvements on the Travenol oxygenator but

Travenol was not interested, so he came to us to ask for help in making the improvement he

envisioned. We signed an agreement with him where we would attempt to improve or help

him improve the oxygenator that was based on his work. We soon discovered, however, that

what he wanted to do would conflict with his earlier work which was licensed to Travenol, so 5

we could not do specifically what he had envisioned. Instead, Dr. DeWall and I came up

with a design for an oxygenator which would not conflict with previous technology. We

checked with our patent attorneys and they confirmed that we could develop our idea without

any conflicts. That was how Edwards Laboratories became involved in the oxygenator field.

Edwards Laboratories spent about a year developing an oxygenator but then decided 10

to abandon the project. At that time I bought Edwards Laboratories’ interest in the work that

had been done on the oxygenator and started Benson Laboratories. During (YR-20), I

worked to improve the Edwards oxygenator. I had no employees at the time, however, much

to my surprise, people who had worked for me at Edwards would come to my facility in their

off hours to work for me without pay. 15

The primary problem with the Edwards oxygenator was that the bubble column was

not functioning consistently. By applying straight engineering principles to the problem I

was able to make a consistently functioning bubble column. During this time I was learning

about physiology and the medical business second hand by consultations with Dr. DeWall,

and by visiting Dr. Al Starr, a prominent doctor, in his facility to observe his techniques. I 20

had first become acquainted with Dr. Starr while I was with Edwards Laboratories by visiting

with him in Portland for a period of two weeks to learn about his work with heart valves.

DONALD BENSON

86

When Dr. DeWall first approached Edwards Laboratories there were two types of

oxygenators on the market. The first type was a reusable, hard-shell mechanical device

which, because it was reusable, created a hazard of contamination between patients. The

second kind of oxygenator was the one based on Dr. DeWall’s earlier work and

manufactured by Travenol Laboratories, which was a disposable device, intended to be used 5

once and then discarded to avoid the problem of cross-contamination. One of the problems

with the Travenol device was that it was a soft shell or “bag” device, that is, it had flexible

walls. The problem was that although it might appear that the device was full of blood it

might in fact be almost empty since the walls were flexible and one might not readily detect

its thickness. As a result, if you took more blood out of the oxygenator than you were putting 10

in, you could suddenly run out of blood without warning.

I was asked in late (YR-22) to come up with a design to improve the Travenol Bag. I

was assigned to replace the internal heat exchanger with an external heat exchanger and to

modify the design to reduce damage to red blood cells. The design modification I came up

with was to put a panel of flexible vinyl on the outside of the bag through which cooling and 15

heating water was run. Although it was not efficient, it did work and I subsequently received

a patent for this device as co-inventor with Dr. DeWall.

Over the next 8 months I made, by hand, probably 200 oxygenators of various

designs. When I thought that one of those designs would work properly I would send it to an

animal laboratory for experimental tests to see if it functioned as it was supposed to. Dr. 20

DeWall was using some of these animal laboratories to determine how they functioned and to

advise me as to what modifications might be necessary. By about September or October

(YR-20), Dr. DeWall decided that the oxygenator was ready to be used clinically.

DONALD BENSON

87

In November (YR-20), Dr. DeWall began using the oxygenators successfully in

clinical cases. He did about 20 or 30 cases, all of which were successful. Soon thereafter I

took my oxygenator to a medical meeting in Denver and received a lot of inquiries about it.

At that meeting I established a distributor and began to sell the oxygenator. This first Benson

oxygenator was called the “Q-100.” 5

In the original Benson Q-100 oxygenator gas transfer was achieved by exposing as

much of the blood as practical to the gas by means of producing bubbles in the blood. It is

desirable to have both large and small bubbles because maximum transfer of carbon dioxide

is accomplished with the largest bubbles while the maximum transfer of oxygen is

accomplished with the smallest bubbles. 10

Mr. Shine also worked for Edwards Laboratories. He left Edwards in (YR-22) and

formed Shine Labs. He went into direct competition with Edwards Laboratories

manufacturing heart valves. It wasn’t until about (YR-9) that he began selling a blood

oxygenator.

I employed a Mr. Brumfield at Benson Laboratories. He then left Benson and formed 15

Harvey. Harvey then later came out with an oxygenator and received a patent on it.

I was continually trying to improve the design of our Benson oxygenators. Our

objective was always to achieve the most amount of mixing of the oxygen and blood while

keeping the velocity of the blood flow to a minimum to minimize damage to the blood cells.

Improvements on the Q-100 led to the introduction of a second series which was called the 20

Q-200 series, and further refinements on the Q-200 series eventually led to the development

of the BOS-10 oxygenator.

DONALD BENSON

88

I designed several oxygenators, each of which was an improvement over previous

designs, in developing the BOS-10 oxygenator. I came up with two designs initially on

January 15, (YR-10). The first of these employs a fin that runs through the bubble chamber

laterally over which the blood could pass, causing a greater mixing of the blood and bubbles

than that achieved with earlier designs. The second design used a rib which gave me a 5

convoluted configuration developed by aluminum sheets. It was my goal to reduce the

turbulence, get low flow, and get very gradual mixing of the blood bubbles.

In March (YR-10) we built an oxygenator which employed a helically coiled tubular

heat exchanger in the bubble column. In our designs we try to employ gentle mixing of the

blood and gas. One of the reasons for employing gentle mixing is to allow the bubbles to get 10

large. When the bubbles get large they tend to burst which is not necessary to defoam the

blood. Small bubbles are much harder to get rid of. If the flow of blood is fast or violent, the

bubbles tend to stay small.

This improvement over the Q-200 became the Q-200A oxygenator for which a patent

was obtained. We filed the patent application for the Q-200A oxygenator in May (YR-9), 15

and this subsequently issued as the Patent No. 4,268,476. Exhibit 20 is taken from figures 7

and 8 of the ‘476 patent. Figure 7 shows a side cutaway view of Q-200A. Figure 8 shows a

cross-sectional view of Q-200A. You can see the helically coiled heat exchanger clearly

indicated as 134. The Lewin ‘264 patent was used against our application but the Patent

Office allowed our patent anyway. 20

The BOS-10 oxygenator is an improvement over the Q-200A oxygenator in that the

turbulence is further reduced. I first got the idea for the BOS-10 oxygenator while I was on

the beach in Hawaii in July (YR-9). When I came back home, I immediately began working

DONALD BENSON

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on this new design. I was sitting there in Hawaii thinking that blood damage is somewhat

proportional to the amount of foreign material that it comes in contact with. It’s not directly

proportional, but there is a relationship. All of the other devices force the blood up and then

back down again. If I could make a device which brought the blood in on top and let it

trickle down through the device under the influence of gravity, and therefore make only one 5

pass from entrance to exit, I would have a shorter path for the red blood cells to follow and

there would be less damage.

I also didn’t want to force the blood through a lot of constrictions in the form of

defoaming material, which can also damage red cells. I wanted a design which allowed the

bubbles, once they had become large, to burst, rather than being broken up again into smaller 10

bubbles. Heat exchange didn’t really bother me. I wasn’t out for a lot of heat exchange. Up

to that point, our devices were quite good. They weren’t the best as far as heat exchange, but

all you have to do to get better heat exchange is to increase the length of the tubing, and I had

plenty of tubing.

When I returned home, I went to an executive meeting at Benson Laboratories and 15

introduced my idea. At the time, I was Vice President of Regulatory Affairs and so I

couldn’t work on the device during the day. Instead, I worked on the first prototype at home,

around-the-clock, for about three days. I wanted to use a bellows as the heat exchanger coil,

however, I couldn’t find one. I checked with various suppliers, but no one had anything. So

I went and bought the next best thing. I went to a hardware store and bought the helically 20

spiral-ribbed flexible tubing that you would use to hook up your gas range or water heater. I

bought length in 5/8” diameter and started coiling these. I soldered the coils together so that

it would make a rigid cylinder. I brought the first prototype to the laboratory and began

DONALD BENSON

90

running it on animal blood. I observed the bubble formations at the top and the blood going

in at the top and going down through the annular rings that I had built, and going out at the

bottom. I could run it only for a short period of time because I didn’t have a defoamer. This

was my first prototype.

The second prototype I built had a defoamer. It had good gas exchange but had 5

problems with the defoaming. I also built this one at home. I built four prototypes in all, but

it wasn’t until the third that I was able to get testing done in the lab at Benson.

I kept no records of the animal laboratory tests for the prototypes because I was just

looking for a visual appearance and how the blood-foam mixture flowed through the

chambers. I was only looking at the tests to get an idea of how to build my next prototype. I 10

turned in receipts to the company, but the company couldn’t find them when asked to

produce them. I’m sure the company has them, but they’re lost in the archives.

The development of the BOS-10 oxygenator was something that evolved over a

number of years. The idea of using the helical coils in an annular ring for a heat exchanger,

as in the ‘476 patent and Q-200A, was an idea that was later incorporated into the BOS-10. 15

The down-flow idea came to me, as I mentioned earlier, while sitting on the beach in Hawaii.

With those two ideas I was then able to begin building the prototypes.

In the BOS-10 oxygenator the blood enters the chamber tangentially so that the blood

goes around the cylindrical chamber in a circle. Thus, when oxygen is introduced there is a

greater exposure of the blood to the oxygen than if the blood was not circulating. The blood, 20

which has been subjected to the bubbles, is now in the form of a blood foam which is

allowed to run over the heat exchanger coil under the force of gravity. The purpose of the

coil is two-fold. First, the coil is used to exchange heat. Second, the coil provides a surface

DONALD BENSON

91

upon which the bubbles can begin to break, which accelerates the defoaming process. The

only purpose of having ribs on this tubing is to increase the surface over which the film can

be created so that there is a higher heat exchange efficiency. The final separation of the gas

from the blood takes place in the defoamer.

We were required by the Food and Drug Administration to file a 510K application to 5

get approval for the introduction of our new oxygenator device into the market. We initially

filed our 510K application in November (YR-9). In response to the initial filing, the FDA

informed us that we would have to provide comparative studies of oxygenators which were

on the market and provide clinical studies. To comply with the FDA requests, I ordered

oxygenators of competitors, including the Shine S-100, so we could test them and compile 10

data. I also collected brochures from the various products to be included with the application.

We compared our BOS-10 with our own Q-200A and also with the Harvey H-1000 and the

Shine S-100. We ordered the Shine oxygenator in December (YR-9). We evaluated the

Shine S-100 oxygenator in December (YR-9).

As a result of those tests I became familiar with the Shine oxygenator. In the Shine 15

device the blood comes into the cylindrically shaped chamber at the bottom. The oxygen

comes in through a porous member which creates bubbles. The blood and oxygen are then

forced through urethane foam which causes a great deal of turbulence in the blood and

exposes more of the blood to the gas. The heat exchanger coil is tightly fit into the cylinder,

forcing the blood and gas to go through various relatively small openings created by the ribs, 20

which creates additional turbulence and higher shear stresses that tend to mix the blood and

the oxygen even further and incidentally, create hemolysis.

DONALD BENSON

92

The Benson BOS-10 oxygenator has a larger heat exchanger than the heat exchanger

in the Shine device because it’s less efficient. In the Shine device, the coil comes in intimate

contact with the outer wall of the cylinder, therefore, all of the blood must come in contact

with the coils. In the BOS-10 oxygenator, 50% of the blood does not go over the coils, but

rather flows along the outer wall of the cylinder. The spacing between the heat exchanger 5

coil and the wall in the BOS-10 oxygenator is not critical. It is approximately 1/8”. Since

there is not as much intimate contact of the blood foam with the coil, the heat exchanger is

less efficient.

I first learned about the Lewin ‘264 patent in early (YR-7) when it was sent to us by

our patent attorneys. I called our patent attorney and discussed the patent with him. We both 10

agreed that it was a different device from the BOS-10 oxygenator and he said there was no

reasonable basis upon which to charge the BOS-10 device with infringement.

While I was at Benson Laboratories, I participated in five or six technology licensing

negotiations. We did not license the technology of others to any great extent because we

considered ourselves the innovators in the field, but we did license our technologies to others. 15

I would take a number of factors into account in determining whether or not it would be

appropriate for Benson to license a patent or related technology. One factor is whether the

technology to be licensed pertained to a market that was large enough to justify considering

taking a license. Another factor is whether or not the technology being presented for license

to us is an improvement over anything that we ourselves had, and whether or not it was in 20

line with our design policy that the best interests of the patient be preserved. In my

experience regarding the licenses I have negotiated, the largest royalty rate was 5%, and the

normal rate was in the 2 to 3% range.

DONALD BENSON

93

If I had been approached by Shine when the ‘264 patent issued in December (YR-8)

and asked to take a license, I would not have taken a license because we already had work in-

house that was superior to Shine’s technology. Also, in our judgment, the Lewin oxygenator

did not consider the patient’s interest first, which is absolutely essential as far as we are

concerned. 5

The language in the portion of Claim 4 of the ‘264 patent which reads “said helical

rib being located in contact with or closely proximate to the inner wall of said oxygenating

chamber so that substantially all of said blood and blood foam produced by said first means

flows in contact with external surfaces of said heat transfer fluid conduit” does not apply to

operation of the Benson BOS-10 oxygenator. As I previously explained, approximately 50% 10

of the blood in the BOS-10 oxygenator flows over the outer wall of the oxygenating chamber.

Shine relies on Exhibit 13, a Benson Laboratory manufacturing procedure document,

to show that the coils in the BOS-10 oxygenator fits tightly within the chamber. This

document states as follows: “While holding outlet tube in position, insert a coil support

fixture rotating in counter-clockwise if necessary, but maintaining a snug fit.” The snug fit 15

that was referred to is just a snug fit with respect to a support fixture during manufacturing; it

is not a part of the oxygenator as sold.

I do not believe that I attended the trade show in July (YR-9) given by the American

Medical Association for Extracorporeal Technicians. If I did go to the show, I did not see the

Shine S-100. Nor do I recall if I went to the Atlanta, Georgia show in (YR-9). The first time 20

I saw the brochure for the S-100 was when it came across my desk for the December (YR-9)

testing following the 510K application for the FDA. I first heard through the grapevine that

DONALD BENSON

94

Shine was introducing an oxygenator, but I didn’t know when the S-100 came on the market,

nor did I know through the grapevine how it worked or what it looked like.

Sales of the BOS-10 oxygenator exceeded those of the Q-series, and it became

uneconomical to continue to produce these devices anymore, so they were discontinued. But

it is not true that the Q-series became obsolete because of significant problems with this 5

device.

Exhibit 12 appears to be a Spiral Tubing Corporation invoice. The words “Sold to”

appear on it. The words below “Sold to” say “Benson Laboratories, 1535 Armstrong Avenue,

Marco Island, Florida.” The date is January 23, (YR-8). Also typed on Exhibit 12 is the

statement “Use special length of Shine material being rushed from Linderme.” I do not recall 10

whether Benson Labs purchased any tubing from Spiral Tubing.

The tubing from which the heat exchange coils are made in the Benson BOS-10

oxygenator is substantially the same as the tubing used in the Shine oxygenator. However, it

is not true that Benson had never used an aluminum helical twisted tube before introduction

of the Shine oxygenator. We had used such an aluminum tube experimentally many times. 15

In fact, we sold twenty five Q-200A where the heat exchanged conduit was modified

with a coated aluminum helical twisted tube in April (YR-10) to the surgery clinic at Cornell

veterinary medicine school for their canine surgery service. We don’t have any samples left

but Benson has a recipe showing this deal. As I mentioned earlier, we were exploring ways

to improve to Q-200A so you could also say those were prototypes of BOS-10, except that 20

they did not have the gravity flow feature I came up with a year later.

DONALD BENSON

95

Nevertheless, it was not my idea to put the Turbotec tubing in the BOS-10 oxygenator.

I wanted to use a bellows, but somebody at Benson decided to use the Turbotec tubing as

found in the Shine device. The Turbotec tubing is cheaper than a bellows.

DEPOSITION SUMMARY OF DR. FRANK GOLLAN

My name is Frank Gollan. I obtained my medical degree from the University of 5

Lausanne in Switzerland in (YR-34). Following residency in internal medicine at the

University Hospital in Zurich, I became an Exchange Fellow at the Cedars of Lebanon

Hospital in Los Angeles. This institution has since merged with Mount Sinai Hospital to

become Cedars-Sinai Medical Center. At Cedars-Sinai I was a member of a research team

involved in the development of the heart-lung machine and artificial kidneys. In (YR-27) I 10

moved to Emory University in Atlanta, Georgia where I became an assistant professor of

physiology and later I became a full professor. I taught at Emory until (YR-18). Since (YR-

18), I have been at Brown University in Providence, Rhode Island where I am a professor of

medical science. In addition to teaching I am serving as vice president for biology and

medicine and heading an artificial organ laboratory. Among the medical devices with which 15

I have worked and experimented since the early (YR-30s) are blood oxygenators.

I am a member of several professional societies, including the American Society for

Artificial Internal Organs in which I have served as president, program chairman for its

national meeting and editor of the journal of the society. I have authored and co-authored

over 100 scientific papers and published books entitled Heart-Lung Bypass and Physiology 20

of Cardiac Surgery.

I am very familiar with the necessary mechanics of extracorporeal blood oxygenation

as well as the physiological benefits derived from lowering the body temperature of a patient

DR. FRANK GOLLAN

96

during cardiac surgery. Because of those benefits, most oxygenators include a heat

exchanger which lowers the temperature of the blood during surgery. In my experiments in

around (YR-30), I demonstrated that the body temperature of animals could be reduced

substantially without any ill effects. Lower temperature results in lower metabolism leading

to safer operation. 5

Exhibits 10C and 10D are from my book entitled Physiology of Cardiac Surgery.

They show two bubble oxygenators I devised and tested in about (YR-30). The oxygenator

of Exhibit 10C was made in my laboratory. The heat exchanger coil was made of copper

tubing. The outer shell was made of clear plastic so that you could observe the operation of

the device. Oxygen was input through a port into the bottom of the chamber. The oxygen 10

was fed through a sintered glass filter disk which formed gas bubbles. Blood was input

through another port and mixed with the gas bubbles, forming a blood foam. The blood foam

traveled up the column and passed over a cooling coil which had an antifoam coating. The

cooling coil was the heat exchanger. Cold or hot water was input through a port, flowed

around and down through the heat exchanger coil and then returned up through the center of 15

the heat exchanger and out another port. An upper chamber surrounded the inner

oxygenation chamber. The upper chamber was filled with plastic fibers coated with antifoam,

which converted the blood foam back into a liquid. The cooled (or heated) oxygenated liquid

blood then exited the device through a port. The coils were smooth and without ribs.

The oxygenator shown in Exhibit 10D is made of glass. It was made for me in (YR-20

30) by Corning Glass Works in Corning, New York. I switched to glass because the glass

coil could be sterilized. The heat exchanger of Exhibit 10D is a Friedrichs condenser, a

standard piece of laboratory equipment. In Exhibit 10D, oxygen is input at the base of the

DR. FRANK GOLLAN

97

device. It flows through a filter which causes the oxygen to bubble. Venous blood is input

through a port into the lower part of the chamber, where the oxygen bubbles and blood mix

together to form a blood foam. Thus, in this stage the oxygenator operates to this point in the

same way as the oxygenator of Exhibit 10C. The blood foam then rises through the inner

chamber into contact with the Friedrichs condenser, which cools (or warms) the oxygenated 5

blood. The oxygenated and cooled (or heated) blood foam passes through a defoaming

material in the top cover. Liquid blood then exits the device.

The Friedrichs condenser comprises a hollow glass column with a hollow rib which

winds around the outer periphery of the column in a helix from one end of the column to the

other end. The outer edge of this rib either touches or is in close proximity to the inner wall 10

of the oxygenating chamber. The spacing between adjacent turns of the rib defines a flute

passage. Blood flows in a helical path around the rib through a passage, spiraling upward

around a column. Cooling water is input through a nozzle into the glass column. It runs

downward, filling the column, including the interior portion of the rib. It exits at the bottom

of the column, running upward through a tube and out a nozzle. 15

Comparing Claim 4 of the ‘264 patent (Exhibit 1) with my glass bubble oxygenator

(Exhibit 10D) shows the following:

First, my bubble oxygenator had an integral heat exchanger for regulating blood

temperature flowing in an extracorporeal blood circuit. Second, the chamber in Exhibit 10D

is an oxygenating chamber. Third, my device has first means for introducing blood and 20

bubbles of oxygen into the oxygenating chamber for forming blood foam within the chamber.

This comprises an inlet port for introducing oxygen into the device, a disk which converts the

oxygen into bubbles, an inlet port into which non-oxygenated blood flows, and a chamber.

DR. FRANK GOLLAN

98

Fourth, my bubble oxygenator includes second means for both (a) oxygenating the blood and

removing carbon dioxide from the blood and (b) regulating the temperature of the blood.

This claim element corresponds to the heat exchanger over which the blood flows.

Continuing on with Claim 4, the heat exchanger has a heat transfer fluid conduit, in

the form of a column. This column has a substantially continuous hollow helical rib along its 5

length. This rib provides a continuous helical flute passage through which the blood flows.

This flute passage is considerably longer than the length of the fluid conduit, since it winds

around the column in a helix. The rib is located in contact with or closely proximate to the

wall of the oxygenating chamber, so that substantially all of the blood and blood foam

produced by the first means flows in contact with the external surfaces of heat transfer fluid 10

conduit. The blood is forced to flow through a plurality of restricted area, extended length

flow paths defined by the helical flute passages. This process results in long residence time

of the blood and blood foam in contact with the heat exchange coils and no areas of

stagnation of the blood and blood foam.

The operation and advantages of my bubble oxygenator designs of Exhibits 10C and 15

10D are discussed in Dr. Galletti’s book, which remains a reliable authority on blood

oxygenator technology.

I understand the term “closely proximate” in Claim 4 to mean “close enough” so that

all the blood-gas mixture will flow in contact with the heat exchanger tubing. The term

“residence time” is a term I had not used prior to this litigation. My understanding of 20

increased residence time simply means that the blood flow is slowed by the circuitous flow

paths.

DR. FRANK GOLLAN

99

I tested the oxygenators shown in Exhibits 10C and 10D at my laboratory. In

addition to my technical staff, all residents in surgery were required to rotate through my

laboratory and probably were present at those tests. Between 40 and 50 students or residents

are on a continual rotation through my lab. I have frequent visitors in my lab because of the

publicity surrounding and great interest in cardiac surgery. Thus, there also may have been 5

visitors present when the tests were conducted of the oxygenators shown in Exhibits 10C and

10D. These tests proved to be successful and the work was neither carried out in secrecy,

concealed, nor abandoned. To the contrary, this work was published.

The experiments conducted with the oxygenators shown in Exhibits 10C and 10D

were done with animal blood and the experimental animals were dogs. At the meeting of the 10

American College of Surgeons in Nashville, Tennessee in (YR-30), I disclosed my design of

an oxygenator with an internal heat exchanger.

My work has always been on animals and I have never used any of the devices I

designed on humans. I never settled on any particular design for my blood oxygenator, but

found that metals such as stainless steel are not good materials to use as heat exchanger 15

conduit because they do not readily transmit heat and are hard to clean to a sterilized state. It

would be years before the device I designed could be used on humans. With respect to any

such design, a different size device would have been necessary for human adults, although

the size of the device in my design was probably appropriate for infants. Present day

oxygenators, including those of the plaintiff Shine, are definite improvements over my (YR-20

30) vintage designs. My design was used to establish principles and was not for use with

patients.

DR. FRANK GOLLAN

100

I have patents in my own name and I am familiar with the patent application process.

I examined all of the prior art cited during the prosecution of the ‘264 patent. I am not a

patent expert but I do have an understanding of the prosecution history of the ‘264 patent as a

scientist.

The person of ordinary skill in around (YR-10) came from either the academic world 5

or from industrial organizations making oxygenators. They were quite aware of the

importance of secondary flow and were aware of ways of improving oxygenator design by

using specially contoured surfaces in order to enhance gas transport and other exchange

phenomena in the oxygenator. This was engineering knowledge that was widely distributed

and the object of common conversation at the time. 10

My book (Exhibits 10A-10D) is referenced in column 1 of the ‘264 patent. In my

opinion Exhibit 10D teaches a person of ordinary skill in the oxygenator art the structure of a

bubble oxygenator with a sparger plate at the bottom associated with a blood inlet for

introducing blood to be mixed with oxygen to form a two-phase mixture of oxygen and blood

in the lower half of a column, and that one of ordinary skill would recognize in the upper half 15

of the column the Friedrichs condenser as essentially a structure with ribs on the outside

surface and with an inlet and outlet for circulating heat exchange liquid. This drawing also

teaches one of ordinary skill that the Friedrichs condenser is immersed in the oxygenating

column so that the mixture of oxygen and blood will have to go up and contact immediately

the outer surfaces of the condenser until eventually it overflows and accumulates in the 20

arterial reservoir.

None of the references cited against Claim 4 of the ‘264 patent during prosecution

describe the particular characteristics found in my oxygenators of Exhibits 10C and 10D.

DR. FRANK GOLLAN

101

Exhibit 9 is an industrial advertisement from Spiral Tubing Corporation describing

twisted tubing for heat transfer. It states that this tubing is “currently applied in biomedical

devices like artificial kidney machines and artificial hearts.” This ad was published in (YR-

11) and (YR-10), several years after publication of my book (Exhibits 10A-10D) and Dr.

Galletti’s book in YR-23. 5

U.S. Patent No. 3,535,267 to Bunnell issued October 13, (YR-15) and U.S. Patent No.

3,015,355 to Humphrey, issued January 2, (YR-23), disclose methods of making specially

ribbed tubing. It would be a relatively simple step for one of ordinary skill in the oxygenator

art in (YR-10) to combine the teachings of my bubble oxygenator of Exhibit 10C with the

Turbotec coil in Exhibit 9 or these patents to make the invention defined in Claim 4 of the 10

‘264 patent. The Turbotec ad states that the tubing described therein can be used as a heat

exchanger and shows that it would be a simple step to form the Turbotec material into a coil

in the concentric oxygenator of the type shown in Exhibit 10C. Exhibit 10C and the

Turbotec advertisement of Exhibit 9 would have taught one of ordinary skill to take the heat

exchanger represented in the Turbotec ad and slip it between the wall and inner cylinder 15

shown in Exhibit 10C to fill the annular space.

The advertisement of Exhibit 9 makes explicit that the reason for using the tubing in a

heat exchanger is that the particular shape will promote turbulence. The ad also says that the

tubing is used in the biomedical field, giving as examples artificial hearts and artificial

kidney machines. The ad pictorially shows that the tubing can be coiled in a very tight 20

assembly. Exhibit 10C teaches introducing a coil in the oxygenating column to serve

simultaneously as a heat exchanger and gas exchanger. To one skilled in the art it would

have been quite natural to use a structure such as the Turbotec tubing with a convolution on

DR. FRANK GOLLAN

102

the outside to make it as efficient as possible. The combination of my work shown in Exhibit

10C and the disclosure of the Turbotec advertisement in Exhibit 9 would meet Claim 4 of the

‘264 patent.

I am familiar with U.S. Patent No. 3,769,162 to Brumfield, which also discloses an

oxygenator having a spiral heat exchanger tube; U.S. Patent No. 3,802,499 to Garcea, which 5

discloses a heat exchanger where the heat exchanger coils are wound helically around a

central column; U.S. Patent No. 3,731,731 to Kyvsgaard, which discloses a temperature

control device for blood; and U.S. patent No. 3,437,450 to Greenwood, which shows an

oxygenator with a spiral heat exchanger ramp in the oxygenating column. In my view these

references would have further suggested the invention of Claim 4 to a person of ordinary 10

skill.

It would have been obvious to one of skill in the art that the device of Exhibit 10D

would produce a countercurrent flow by introducing liquid in the upper part of the Friedrichs

condenser and draining it from the bottom of the condenser while introducing blood and

oxygen in the bottom of the device and removing it from the top. The teachings of Exhibits 15

10C and 10D are more relevant to the claimed subject matter of the ‘264 patent than any of

the patents listed by the Examiner on the first page of his Office Action or any of the

references cited in the text of the patent.

At or about the time of the invention in the ‘264 patent there was an interest in the

blood oxygenator community and those involved in the design thereof in the use of specially 20

contoured surfaces and convoluted surfaces for the purpose of enhancing gas exchange. This

would suggest to a person of ordinary skill the desirability of combining the structure shown

in Exhibit 10C with the Turbotec tubing.

DR. FRANK GOLLAN

103

Prior to (YR-9) and the Shine oxygenator coming on the market, I was not aware of

any bubble oxygenator that used twisted aluminum tubing for the heat exchanger to get both

good heat transfer and good gas transfer.

With respect to Claim 4 of the ‘264 patent (Exhibit 1), my oxygenator as shown in

Exhibit 10C contains a blood oxygenator with an oxygenating chamber and means for 5

introducing blood and bubbles of oxygen into the chamber for forming a blood foam which

absorbs oxygen and releases carbon dioxide. This is shown in the bottom portion of Exhibit

10D, where oxygen comes in through a tube into the chamber and is passed through a

sintered glass filtered disk, which generates gas bubbles.

There are several differences between the BOS-10, which is Exhibit 18, and Exhibit 10

2C, the oxygenator disclosed in Figure 3 of the ‘264 patent. First, Exhibit 18 shows the heat

exchanger coils exiting from the top of the device. This is not found in Exhibit 2C. In

Exhibit 2C water is input at the upper side of the oxygenating chamber through opening 85

and it exits on the side at the bottom of the oxygenating chamber. Second, there is no

opening at the top of the oxygenator in Exhibit 2C. Third, the defoamer in Exhibit 18 is 15

concentric to the oxygenator, whereas in Exhibit 2C the defoamer is to the side of the

oxygenator. Fourth, there is a sponge 109 in Exhibit 2C, but no such sponge in Exhibit 18.

Fifth, Exhibit 18 shows a long tube running through the center of the oxygenator which feeds

the heat exchange fluid back up through the top of the device. There is no such tube in the

oxygenator of Exhibit 2C. Sixth, Exhibit 2C does not teach the use of antifoam on the heat 20

exchanger coil, while Exhibit 18 teaches such use. In my view, these differences are trivial

and in any event, are not recited in Claim 4.

DR. FRANK GOLLAN

104

I would not know how many flutes or helical ribs in the Turbotec coil are used with

my oxygenator of Exhibit 10C without performing calculations and testing. I have never

bought a Turbotec coil and put it in the oxygenator of Exhibit 10C.

I have reviewed Claim 4 of the ‘264 patent and compared it to the Benson BOS-10

device. 5

As to the element marked “H” of the ‘264 patent, the helical rib of the BOS-10, as

manufactured, can be up to 1/8” away from the inner chamber wall and the device will

function correctly. Even though there is no manufacturing specification as to how close the

ribbed tubing can be placed to the inner chamber wall of the BOS-10, I do not consider the

rib to be “closely proximate” to the inner wall of the BOS-10. 10

As to element “I” in the BOS-10, a substantial amount of the blood flows down the

side of the inner chamber wall and mixes at the bottom with blood that has flowed in contact

with the heat transfer conduit, so substantially all the blood and blood foam does not flow in

contact with the heat transfer conduit.

As to element “N” in the BOS-10, there is no “long residence time of the blood and 15

blood foam in contact with said heat transfer fluid conduit” because in the BOS-10, the blood

is always flowing pulled by gravity through the device.

It is my personal conclusion that the BOS-10 does not infringe the Shine ‘264 patent.

20

105

Shine v. Benson

Exhibits

Table of Contents

Exhibit No. Description Page No.

1…………… Claim 4 of the ‘264 Patent…………...……………………...………….. 132

2A -L……… U.S. Patent No. 4,065,264…………………………………....….……… 134

3…………… Letter from Shine to Benson on 11/13/(YR-5)………………….……… 158

4…………… Drawing of Heart-Lung Machine Configuration.…………....….……… 160

5…………… Drawing of the BOS-10 Oxygenator…………………………...…….… 162

6A-C……… Labeled Photos of BOS-10 Oxygenator.……………..……....….……… 163

7…………… Drawings of Shine Model S-100 Oxygenator…..………..…….…..…… 170

8…………… Chart of Performance Factors………………..…………….……….…… 172

9…………… Turbotec Advertisement on 10/31/(YR-11)………………….……...…… 174

10A-D..…… Portions of Physiology of Cardiac Surgery by Dr. Gollan.......….….…… 176

11.………… Excerpt of Heart-Lung Bypass by Dr. Galletti.……………....….……… 182

12.………… Spiral Tubing Corp. Invoice to Benson, dated 1/23/(YR-8)……..……… 184

13.………… Benson Revised Manufacturing Procedure, dated 11/10/(YR-4)…...…… 186

14.………… Table, Unit Sales of Benson and Shine Oxygenators*……...….…..……. 188

15.………… Chart, Unit Sales of Benson and Shine Oxygenators*…………......……. 190

16.………… Table, Dollar Sales of Benson and Shine Oxygenators*……….…..……. 192

17.………… Chart, Dollar Sales of Benson and Shine Oxygenators*……….…..……. 194

18.………… Benson BOS-10 Device ………………………………………Physical Exhibit

19.………… Invoice of sale from Benson to Cornell University……….…..……. 196

20A-C……… U.S Patent No. 4,268,476………………………….……….…..……. 198

*From (YR-9) through (YR-2).[

107

Exhibit 1

108

Exhibit 2A

109

Exhibit 2B

110

Exhibit 2C

111

Exhibit 2D

112

Exhibit 2E

113

Exhibit 2F

114

Exhibit 2G

115

Exhibit 2H

116

Exhibit 2I

117

Exhibit 2J

118

Exhibit 2K

119

Exhibit 2L

120

Exhibit 3

121

Exhibit 4

Heart-Lung Machine Configuration

123

Exhibit 5

124

Benson BOS-10 Blood Oxygenator

125

Exhibit 6B


126

Exhibit 6C


127

Exhibit 7

Exhibit 8

Shine S-100 Blood Oxygenator

Performance Factor

128

5

10

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129

Exhibit 9

5


130

Exhibit 10A


131

Exhibit 10B

5

10

15

20

25


132

This page left intentionally blank

133

Exhibit 11

CHAPTER 3: MATERIALS IN EXTRACORPOREAL CIRCUITS · 37

METALS

Where mechanical strength and stiffness are the primary requirements for parts of an

extracorporeal circuit, metals are commonly used. Though cheap and easy to machine,

copper and brass have long been recognized as inadequate in perfusion technology because

they are easily oxidized and release toxic ions when exposed to watery media. Chromium-

plated surfaces have proven disappointing, because pinholes subsist in the plating, through

which contact with the basic material is still possible. Nickel and nickel alloys appreciated

for their unusual toughness and corrosion resistance, were proposed by Tainter (YR-53) but

never gained a wide acceptance, possibly because of the price. Reports of nickel sensitivity

as a cause of infusion reaction (Stoddart, YR-25) may also deter from their use. Despite a

lack of hardness, silver has been used where its high thermal conductivity coefficient is of

particular benefit (heat exchanger surfaces). Gold and gold-plated parts are acceptable, but

their price is prohibitive. Aluminum and light metal alloys are still the subject of

controversy. Beland, et al. (YR-47) experienced a considerable degree of toxicity which

could, however, be overcome by simple passage of the arterialized blood through the animal

lung. They surmised that aluminum hydroxide is formed on the surface of the metal exposed

to blood, leading to the precipitation of plasma proteins and capillary embolisms. The lung

was through to act as a filter for the small particles because it was of no help when inserted

into the venous line. Diettert, et al. (YR-32) have used disposable aluminum screens in their

artificial lung, but did not observe any toxic effect during the course of perfusion. It may very

well be that the presence of other metals in aluminum alloys and the kind of finishing of the

surfaces determine their blood handling properties and that a suitable material from that class

will be developed someday.

From the evidence presently available, stainless steel is the material of choice. Not

too expensive, it can be machined into complicated shapes and provided special welding

techniques are used, connected to other pieces without creating dangerous recesses or joints.

It readily transmits heat, can be easily cleaned by mechanical or chemical means and permits

sterilization by autoclaving. The chromium-nickel type alloys are the most widely used.

They are normally nonmagnetic and show the highest corrosion resistance of all types of

stainless steel as well as unusually fine mechanical properties. The types of standardized as

304 (18-20 per cent chromium, 8-12 per cent nickel) and 316 (16-18 per cent chromium, 10-

14 per cent nickel, 2-3 per cent molybdenum) are preferred because they combine the

mechanical qualities of steel with a high degree of biochemical inertia. They can be

electropolished to the point where their surface becomes almost atraumatic to blood (Bass

and Broida, YR-21; Adams, et al., YR-27). Other alloys, such as 303 and 17-4PH, are

considered for special applications (Watkins and Hering, YR-35). As for other surgical

metals, it is still not clear whether the biochemical mertia and tissue tolerance of stainless

steel is primarily dependent on the alloy composition, the degree of annealing, the hardness,

the polish, or more complex properties such as electrical surface potential (Fleisch and

Stauffer, YR-24) or thermal electromotive forces. Development of better alloys, must,

therefore, be promoted by

Excerpt from: Pierre M. Galletti, HEART-LUNG BYPASS 37 (YR-23).

134

Exhibit 12


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135

Exhibit 13


136

Exhibit 14

Sales of Oxygenators – Units


137

Exhibit 15

Sales of Oxygenators – Units


138

Exhibit 16

Sales of Oxygenators – Dollars


139

Exhibit 17

Sales of Oxygenators – Dollars


140

Exhibit 19


141

Exhibit 20A

Exhibit 20B


142


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