655web.stanford.edu/~rjmorris/sciev.07/pruitt.doc · Web view18 modification of medical polymers...

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1 Volume 3

2 Pages 424 - 654

3 UNITED STATES DISTRICT COURT

4 NORTHERN DISTRICT OF CALIFORNIA

5 BEFORE THE HONORABLE SUSAN ILLSTON

6 BOSTON SCIENTIFIC CORPORATION, ) et al., ) 7 ) Plaintiffs, ) 8 ) VS. ) No. C 02-0790 SI 9 ) JOHNSON & JOHNSON and CORDIS )10 CORPORATION, ) ) San Francisco, California11 Defendants. ) Wednesday -----------------------------------) October 11, 200712 CORDIS CORPORATION, ) 8:30 a.m. )13 Counterclaim-Plaintiff, ) )14 VS. ) )15 BOSTON SCIENTIFIC CORPORATION, ) et al., )16 ) Counterclaim-Defendants. )17 ___________________________________)

18 TRANSCRIPT OF PROCEEDINGS APPEARANCES:19 For Plaintiffs: Wilmer Cutler Pickering Hale and Dorr20 60 State Street Boston, Massachusetts 0210921 By: William F. Lee, Esquire Dominic E. Massa, Esquire22

23 (Appearances continued on next page)

24 Reported By: Katherine A. Powell, CSR 5812, CRR Debra L. Pas, CSR 11916, CRR25 Official Reporters - US District Court

425

1 APPEARANCES CONTINUED:

2 For Plaintiffs: Wilmer Cutler Pickering Hale and Dorr 1117 California Avenue 3 Palo Alto, California 94304 By: Mark D. Selwyn, Esquire 4

5 For Defendants: Sidley Austin LLP One South Dearborn 6 Chicago, Illinois 60603 By: David T. Pritikin, Esquire 7 William H. Baumgartner, Jr., Esquire

8 Johnson & Johnson One Johnson & Johnson Plaza 9 New Brunswick, New Jersey 08933 By: Eric I. Harris, Esquire10

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PROCEEDINGS 426

1 P R O C E E D I N G S

2 OCTOBER 11, 2007 8:38 A.M.

3

4 (Proceedings held in open court, outside

5 the presence and hearing of the jury.)

6 THE COURT: Good morning.

7 ALL COUNSEL: Good morning.

8 THE COURT: There were things you want to talk about?

9 You may be seated.

10 MR. LEE: Yes, Your Honor.

11 There are two things that will arise with the two

12 witnesses that follow, not completing Mr. Meyer's direct and

13 cross-examination, but two witnesses that follow. And I wanted

14 to alert the Court to them.

15 THE COURT: Okay. How long is this going to take,

16 because we are making the jury wait on this one?

17 MR. LEE: Well, Your Honor, both of these are -- I

18 don't know how long it's going to take. They are pretty

19 important. They go to the subject of the testimony of these

20 two witnesses.

21 Maybe I can just describe them for you, and you can

22 tell us when you would like to address that.

23 THE COURT: Maybe we can talk about it at a break.

24 Go ahead.

25 MR. LEE: There are two. First we received a

PROCEEDINGS 427

1 demonstrative.

2 THE COURT: Right. If it has to do with that motion

3 Tracy put on my desk, I read that.

4 MR. LEE: Your Honor, there is a criticism of us for

5 not having moved, I mean, the equivalence was in a six-line

6 footnote. But if we had moved in limine on every theory and

7 every footnote, Your Honor would have been even more upset with

8 the number of in limine motions.

9 THE COURT: Perhaps. But you have to balance that

10 off against the untimeliness of the request.

11 MR. LEE: Well, but, Your Honor, this is objecting to

12 testimony. This testimony -- actually, their brief is very

13 helpful because their brief is clearer than her opinion and

14 it's clearer than anything that's been given to us before. And

15 what engendered this is the demonstrative they sent, that's

16 going to set forth --

17 THE COURT: If she wants to testify to something that

18 wasn't in her report, that's one thing. But you're not making

19 it on that ground, right?

20 MR. LEE: Your Honor, you know, it's a six-line

21 footnote that's general. And is it mentioned? The answer is,

22 yes, it's mentioned.

23 But if Your Honor looks at Claim 7 of the Fontirroche

24 patent and just looks at Lines 46 to 48, you will see that the

25 opinion that's articulated in the demonstrative and in their

PROCEEDINGS 428

1 brief is inconsistent with the claim. And I think that's an

2 objection that I have to raise.

3 THE COURT: All right. Well you have raised it.

4 MR. LEE: The second one is this: They sent at 10

5 o'clock last night -- 9 o'clock last night an animation from

6 their cardiologist with a parade of horribles that could happen

7 if there was delamination and dissection.

8 Your Honor may recall we had this at the interference

9 trial. This is one expert saying that there could be

10 delamination, without identifying the circumstances; a doctor

11 then reading her report, not even talking to her, and saying,

12 well, if that could happen then this could happen to the

13 patient.

14 And that is really speculation built upon

15 speculation. And they intend to offer that animation today,

16 first without having put in the underlying predicate that the

17 delamination could cause these problems, and then have him

18 describe all of these parade of horribles that could occur to a

19 patient.

20 First, it's inadmissible because of the speculation.

21 Second, there is a 403 problem with it. And if it goes in

22 before they have laid the predicate, the horse is out of the

23 barn.

24 THE COURT: Well, we can talk about before the

25 witness is called, which I presume will be after our first

PROCEEDINGS 429

1 morning break.

2 MR. LEE: I think that's right.

3 THE COURT: All right. And this other thing, will

4 that likewise be after the first morning break?

5 MR. LEE: I think so.

6 THE COURT: All right.

7 MR. LEE: Your Honor, I think we fairly joined the

8 issue, and I would ask Your Honor to look at Claim 7, the first

9 paragraph, at Column 8, line 47 to 49, which is the only claim

10 that's in issue.

11 And, actually, I think if Your Honor judges that

12 against their brief, you'll see precisely the issue.

13 THE COURT: All right. I will look at that.

14 MR. PRITIKIN: One quick procedural point, Your

15 Honor, on this. We got that brief at a quarter to 10:00 last

16 night, and it concerns Dr. Pruitt's expert report.

17 My trial team was up until the wee hours of the

18 morning looking at that and trying to put together a response.

19 I don't think it's fair for us to get things like

20 that and have to respond to them in the wee hours of the

21 morning.

22 THE COURT: When had they gotten her demonstrative?

23 MR. PRITIKIN: They got the demonstrative yesterday

24 morning.

25 MR. LEE: But they had known about her report, Your

PROCEEDINGS 430

1 Honor, since June of this year.

2 THE COURT: He says it's line 6 of footnote 12 of the

3 fine print.

4 MR. PRITIKIN: They took her deposition. This is not

5 something that's --

6 THE COURT: I agree with you and with the frustration

7 you express. On the other hand, trial is a very tough job, and

8 there is a night crew for reasons.

9 MR. PRITIKIN: There is a night crew. But when you

10 get something like this and you've got people like Bill

11 Baumgarten and me who have to look at this, and we're getting

12 these briefs at 9:30 at night when we are trying to get ready

13 for the next day and get a little sleep, I just think that's

14 something that is perhaps a little over the top.

15 MR. LEE: Your Honor, can I just have 30 seconds to

16 respond?

17 THE COURT: Yes.

18 MR. LEE: Your Honor, we got the demonstrative

19 yesterday and we came back -- I came back from court. We made

20 the decision to file the brief. We got it filed promptly.

21 These things happen at trial. We got this animation -- we were

22 supposed to have exchanged the demonstratives yesterday

23 morning. We got their animation at 9:30 last night. I'm not

24 complaining.

25 THE COURT: Exactly.

PROCEEDINGS 431

1 MR. LEE: We've just got to deal with it, right.

2 THE COURT: Right. Thank you. Are we ready?

3 MR. PRITIKIN: Yes.

4 (Jury in at 8:43 a.m.)

5 THE COURT: Welcome back, ladies and gentlemen. You

6 may be seated.

7 All right Mr. Selwyn, you may continue. Mr. Meyer,

8 you are under oath from yesterday, sir.

9 PAUL MEYER,

10 called as a witness for the Plaintiff herein, having been

11 previously duly sworn, resumed the stand and was examined and

12 testified as follows:

13 MR. SELWYN: Thank you, Your Honor.

14 Could we please have demonstrative Exhibit PDX-D10.

15 I'm sorry, PDX-D10. Perfect.

16 DIRECT EXAMINATION RESUMED

17 BY MR. SELWYN:

18 Q. Mr. Meyer, when we talked yesterday we were reviewing the

19 reasonable royalty analysis under the Georgia-Pacific factors.

20 Do you recall that?

21 A. Yes, I do.

22 Q. And we had just finished reviewing the three factors that

23 you concluded had a significantly upward influence on the

24 starting point royalty, correct?

25 A. That's correct.

LIANG - RECROSS EXAMINATION / LEE 598

1 A. Yes.

2 Q. And the standards and the principles that Cordis used in

3 adding Mr. Trotta would tell us something about what the right

4 standards and principles are in evaluating the addition of

5 Ms. Byam and Mr. Goodin, correct?

6 MR. PRITIKIN: Objection, Your Honor.

7 THE COURT: Sustained.

8 BY MR. LEE:

9 Q. You would agree with me that in terms of adding inventors

10 the same principles apply to both parties, correct?

11 A. I'm not a patent attorney, so I couldn't tell you one way

12 or the other, sir.

13 MR. LEE: Fair enough.

14 Nothing further, Your Honor.

15 THE COURT: Thank you. You may step down, sir.

16 THE WITNESS: Thank you.

17 (Witness steps down.)

18 THE COURT: Now, Mr. Baumgartner.

19 MR. BAUMGARTNER: Thank you, Your Honor.

20 THE COURT: I'm sorry.

21 MR. PRITIKIN: That's fine.

22 MR. LEE: I'm going to move this, Your Honor.

23 THE COURT: Okay.

24 MR. BAUMGARTNER: Cordis calls Lisa Pruitt.

25 THE CLERK: I'm going to take your picture.

LIANG - RECROSS EXAMINATION / LEE 599

1 Ma'am, if you could just please raise your right

2 hand.

3 LISA ANN PRUITT,

4 called as a witness for the Defendant herein, having been first

5 duly sworn, was examined and testified as follows:

6 THE WITNESS: I do.

7 THE CLERK: Thank you.

8 Okay. If you could state your full name for the

9 record, please.

10 THE WITNESS: My name is Lisa Ann Pruitt,

11 P-r-u-i-t-t.

12 THE CLERK: Okay. Thank you.

13 MR. BAUMGARTNER: Ladies and gentlemen of the jury,

14 Professor Pruitt is a professor at the University of California

15 at Berkeley, where she holds the Lawrence Talbot chair of

16 engineering. She works in the field of mechanical engineering

17 and bioengineering, particularly as they relate to the use of

18 polymers in medical devices. She will testify regarding

19 whether or not Boston Scientific's products meet the claims of

20 the asserted Cordis patent.

21 DIRECT EXAMINATION

22 BY MR. BAUMGARTNER:

23 Q. Well, let's start out, Professor Pruitt, with some

24 personal information. Where do you live?

25 A. I actually live in Northern California, in Petaluma.

PRUITT - DIRECT EXAMINATION / BAUMGARTNER 600

1 Q. What do you do for a living?

2 A. Professor of mechanical engineering and bioengineering.

3 Q. Can you explain for us what bioengineering is?

4 A. Yes. Bioengineering essentially is using engineering

5 disciplines, mechanical engineering as an example, to try to

6 solve biological problems or clinical problems or any medical

7 problems we might have.

8 Q. Does bioengineering have any practical uses?

9 A. Yes. Probably the best example is medical devices as

10 you're hearing about today, where we try to really bring

11 engineering into the design and use of a medical device.

12 Q. Do you have a particular research interest within the

13 field of bioengineering?

14 A. The research specialty of my research group is really to

15 focus on medical polymers and tissues. The medical polymers

16 specific to medical devices used in the body, such as the

17 devices that you're hearing about today.

18 Q. Now, you do research. Do you teach classes, as well, over

19 at Berkeley?

20 A. I do.

21 Q. Do angioplasty catheters play a role in any of the classes

22 that you teach?

23 A. Yes. There's -- there's one undergraduate class that I

24 teach. It's entitled, Structural Aspects of Biomaterials.

25 Essentially, it's medical device design.


1 And one element of that class is to actually talk

2 about medical devices. And we break that down to orthopedics

3 or cardiovascular or soft tissue applications.

4 And in that context, we bring in guest lecturers,

5 we've developed lectures to try to teach the students what's

6 actually needed in angioplasty design, catheter design, what it

7 is.

8 You've heard some of these comments today, actually,

9 about trackability, pushability, flexibility, lubricity. All

10 those concepts are covered in that lecture.

11 Q. Have you ever the chance s to see a real angioplasty

12 procedure on a human patient?

13 A. Yes, I have. I've actually seen a few of those

14 procedures.

15 Q. Now, can you explain for us what it means to be a

16 professor at a university and have an endowed chair?

17 A. An endowed chair is a named professorship. Typically,

18 it's named after the person that's donated funds to the

19 university.

20 I hold the Lawrence Talbot chair. It's named after a

21 colleague of mine that deceased a few years ago. It usually

22 recognizes someone in a specific research field. The Lawrence

23 Talbot chair recognizes someone who has made major

24 contributions in bioengineering and mechanical engineering.

25 Q. Do you hold any positions at any other universities in


1 California, apart from Berkeley?

2 A. Yes. In addition to UC Berkeley, I have an adjunct

3 faculty position in the Department of Orthopedic Surgery at

4 UCSF Medical School.

5 Q. Now, can you remind all of us what orthopedic surgery is.

6 A. Yes. Orthopedics really deals with the bones and joints.

7 So we do a lot of device design for total hips, total knees,

8 total shoulder replacements.

9 Q. And what do you do over at UCSF, as an adjunct professor

10 of orthopedic surgery?

11 A. In that role, I would give lectures to residents or I do

12 an early morning lectureship to practicing orthopedic surgeons.

13 I would also direct young residents in my laboratory for up to

14 a year to do research in orthopedics.

15 And then I have a strong collaboration with the chief

16 of arthroplasty, so a lot of orthopedics research is also

17 performed.

18 Q. Let's change gears a little bit here.

19 Can you explain for us what it means to have a

20 peer-reviewed scholarly paper?

21 A. Yes. As an academic, often we're judged by our

22 publications.

23 When we write a paper, we submit it to a journal.

24 And that journal paper then is disseminated to what would be

25 our peers or colleagues around the world or around the nation.


1 And they would scrutinize and evaluate and make sure that it's

2 technically correct, that it's publishable.

3 Those comments go back to the editor. And then

4 assuming all comments look appropriate, that paper would be

5 published in a journal.

6 Q. How many peer-reviewed papers have you either published in

7 a journal or presented at a scholarly meeting after the peer

8 review?

9 A. At this time, close to 200.

10 Q. Now, what are some of the journals where your work has

11 been published?

12 A. Probably of most relevance I've published in the journal

13 entitled Polymer, which focuses on, essentially, polymers as

14 they're used in engineering applications.

15 We have published in the Journal of Biomedical

16 Materials Research, which focuses on materials that are used in

17 medical devices or in the body. Also, there is a journal

18 entitled Biomaterials. Those would be three of our prevalent

19 journal sites.

20 Q. Let's quickly review your educational background.

21 Can you tell us when you graduated from college?

22 A. I graduated in 1988 from college.

23 Q. And where did you go?

24 A. I was an undergraduate at the University of Rhode Island.

25 Q. How many undergraduate degrees did you get when you


1 graduated?

2 A. As an undergraduate, I pursued two engineering degrees and

3 received two engineering degrees. One was in chemical and

4 ocean engineering and the other is in materials engineering.

5 Q. Did you work during college?

6 A. I did.

7 Q. What did you do?

8 A. Each summer I worked at engineering firms. The last two

9 years in particular I worked as a research engineer at the Army

10 Research Labs in the corrosion science division.

11 Q. That's for the U.S. Army?

12 A. That's for the U.S. Army.

13 Q. Can you tell us, just briefly, what you did for the U.S.

14 Army during college?

15 A. Sure. Actually worked on the pitch links that are used

16 for the Apache helicopter. Worked on the corrosion aspects of

17 the alloy, worked on the fracture issues, the fracture

18 mechanics issues. So essentially worked on both corrosion and

19 the mechanical failure modes that could exist in that alloy.

20 Q. So you graduated from college in 1988, having worked for

21 the Army. What did you do then?

22 A. Academia was so fun that I went on to graduate school at

23 Brown University.

24 Q. And did you receive any degrees from Brown?

25 A. Yes. I received a master's degree in engineering, and


1 then stayed on for a Ph.D., also in engineering.

2 Q. And you received a Ph.D. degree when?

3 A. 1993.

4 Q. What happened then?

5 A. From Brown, I went directly to Berkeley. So relocated

6 from the East Coast to the West Coast.

7 Q. And your initial position there was?

8 A. I was hired as an assistant professor in mechanical

9 engineering.

10 Q. And you worked your way up to the ranks to where you are

11 now?

12 A. That's right. I've been there ever since. And been

13 promoted both in mechanical engineering and bioengineering to

14 full professor.

15 Q. Now, this is a patent case, so I guess I should ask you if

16 you have any patents.

17 A. I do. I hold two patents on the topic of surface

18 modification of medical polymers for medical devices.

19 Q. Would you take a look at Defendant's Exhibit 1 in your

20 exhibit notebook. The Fontirroche patent '594 patent.

21 MR. BAUMGARTNER: And at this time, Your Honor,

22 Cordis would offer Defendant's Exhibit 1.

23 THE COURT: Any objection?

24 MR. LEE: None, Your Honor.

25 THE COURT: Thank you. It will be received.



2 Q. Have you had a chance to review this patent in preparation

3 for your testimony here today?

4 A. Yes, I have.

5 Q. Now, can you tell us, just in a sentence or two, what the

6 invention of the Fontirroche patent involves.

7 A. Yes. As you've heard a little bit about today, the basis

8 of this or the major outcome of this patent is that we have a

9 co-extruded tube with an outer layer and an inner layer. And

10 those two layers are bonded together. And that the inner layer

11 provides flexibility and lubricity to that guidewire tube.

12 Q. Does the Fontirroche patent talk about a particular kind

13 of bond?

14 A. It does. It specifically refers to a bond. And it's been

15 issued by the Court that would be a chemical bond.

16 Q. All right. Now, were you asked to focus on a particular

17 issue in this case?

18 A. Yes. I was asked to focus on whether the Boston

19 Scientific products infringed on one particular claim of this

20 patent. And that's Claim 7 of the '594 patent.

21 Q. And did you reach a conclusion?

22 A. I did. After looking at the claim and looking at the

23 Boston Scientific products, it's my opinion that, in fact, the

24 Boston Scientific products do infringe on Claim 7.

25 Q. Let's go into just a little bit more detail, so we can


1 understand the basis for what you're saying.

2 Have you brought along today a chart that explains

3 what the Maverick family of products at Boston Scientific is?

4 A. Yes, I have.

5 Q. Could you refer to Defendant's Exhibit 3011 in your

6 exhibit notebook, please.

7 A. Yes.

8 Q. Is that your chart?

9 A. Yes, it is.

10 MR. BAUMGARTNER: Your Honor may we display

11 defendant's Exhibit 3011 to the jury?


13 MR. LEE: No objection.

14 THE COURT: Yes, you may.


16 (Document displayed)


18 Q. Professor Pruitt, could you explain for us briefly what

19 the Maverick family of products is.

20 A. Okay. The Maverick family is a class of family of balloon

21 catheters manufactured by Boston Scientific. And it's divided

22 here into three columns.

23 So on the left we've got just our basic balloon

24 angioplasty catheters. That's the Maverick over-the-wire.

25 You've heard about that being the long wire of catheter tube.


1 You're heard about the Rapid Exchange with the

2 Maverick Rapid Exchange, the Maverick 2 Rapid Exchange, the

3 Quantum Maverick over-the-wire, the Quantum Maverick Rapid

4 Exchange, the Maverick XL and the Ultrasoft SV.

5 And then second category, again, you've heard a

6 little bit about this today. That would be just a bare metal

7 stent that's delivered on the tip of that balloon. That

8 includes the Express 2 over-the-wire, the Express 2 Rapid

9 Exchange, the Liberte over-the-wire, the Liberte Rapid

10 Exchange.

11 And, again, you've heard about this today

12 (indicating), the drug-eluting stent. So also a stent system

13 delivered on the balloon. And that includes the Taxus Express

14 2 over-the-wire, the Taxus Express 2 Rapid Exchange, the Taxus

15 Liberte over-the-wire, and the Taxus Liberte Rapid Exchange.

16 Q. How similar is the guidewire tube design in the Maverick

17 family of products?

18 A. So for the family itself, looking at all three categories,

19 the design of the guidewire tube is the same.

20 Q. Have you brought along a picture to illustrate the

21 guidewire tube design in the Maverick family of products?

22 A. Yes, I have a schematic of that.

23 Q. Could you take a look at Defendant's Exhibit 3014 in your

24 exhibit notebook. Is that your picture?

25 A. Yes, it is.


1 MR. BAUMGARTNER: Your Honor, may we display

2 Defendant's Exhibit 3014 to the jury?


4 MR. LEE: I think -- no objection.

5 THE COURT: All right. You may.




9 Q. Can you tell us, Professor Pruitt, using your drawing,

10 what the inner layer of the guidewire tube is made from in the

11 Maverick family of products, and show us where it is on this --

12 on this chart.

13 A. Yes. This is a cross-section of the guidewire tube. The

14 inner layer, which is the high-density polyethylene, is denoted

15 by this dark green inner circle. So that's the interface to

16 the guidewire.

17 Q. And what is the thickness of that inner layer?

18 A. So it's highlighted here. It's .0008 inches in thickness.

19 Q. Now, is there any benefit to having an inner layer of

20 high-density polyethylene in a guidewire tube?

21 A. Yes. You heard Mr. Liang talk about some of the design

22 requirements. One aspect is how easy it is to push a guidewire

23 through this lumen, this opening.

24 And so high-density polyethylene is what's known as a

25 lubricious polymer. It's got a slippery nature to it. So it


1 provides lubricity to that catheter.

2 Q. All right. Let's move now to the outer layer. What is

3 the outer layer made from in the guidewire tube for the

4 Maverick family of products?

5 A. Okay. The outer layer is denoted here in the red outer

6 circle. And that's Pebax, which is a polyester polymer.

7 Q. What is the purpose of the Pebax layer?

8 A. So the Pebax layer is the outer layer. Provides some

9 stiffness. Again, that's an important feature for the catheter

10 tube design. And, also, it provides compatibility to a balloon

11 that needs to be attached to this guidewire.

12 And so the Pebax would be highly compatible with

13 another Pebax balloon.

14 Q. Now, there is a middle layer shown on your drawing. What

15 is that made from?

16 A. Okay. So in the lighter green region, which is sandwiched

17 between the dark green high-density polyethylene and the outer

18 Pebax layer, we have what's known as a tie layer. So it

19 actually ties two dissimilar materials together. And that's

20 what we see as Plexar. And that's a maleic anhydride linear

21 low density polyethylene.

22 My mom used to say engineering is a foreign language

23 in itself.

24 Q. So there's polyethylene in the high-density polyethylene

25 layer and there's polyethylene in the Plexar layer?


1 A. That's correct. Both of these features in green comprised

2 a polyethylene as its base chain.

3 Q. Now, if you took the Plexar layer out of the guidewire

4 tube, what would happen?

5 A. If we take the Plexar layer away, we would lose capacity

6 for a chemical bond. The chemical bond is actually denoted

7 here schematically with a yellow dash line between the Plexar,

8 which is the tie layer, the middle layer. And that Plexar

9 actually has additional groupings, so that maleic anhydride

10 facilitates a chemical bond to that outer Pebax layer.

11 Q. If you had no chemical bond between the layers, would

12 there be anything to hold the tube together?

13 A. If we don't have that bond, we would have no ability to

14 hold those layers together.

15 Q. Would there be any forces that would hold them together?

16 A. Yes. We could have frictional forces. So you could stick

17 one garden hose inside another, but you could pull that hose

18 free. So you would have friction, but you would not have

19 structural bond.

20 Q. How much better is the attachment you get when you use the

21 Plexar tie layer?

22 A. I presume it would be significantly improved to not having

23 a chemical bond.

24 Q. And is there any benefit to that, that you know of?

25 A. Yes. One of the big concerns that we would worry about in


1 guidewire tube design would be making sure that we had

2 integrity between these layers.

3 If we didn't have a strong bond to attach an inner

4 layer to an outer layer, and we had separation, we could have

5 what's known as delamination, where one inner layer actually

6 peels away from the outer layer.

7 And then the consequence of that could be that a

8 guidewire that's trying to pass through could get hung up at

9 that point, which could be clinically extremely inappropriate

10 or dangerous.

11 Q. Let me read you a statement from the Boston Scientific

12 opening statement. The statement is:

13 "Boston Scientific's products don't have two layers.

14 There are three. They don't have a chemical bonds."

15 Is that statement correct?

16 A. The Boston Scientific products do have a bond. This is a

17 cross-section of a Boston Scientific product. And as we see

18 here in the yellow hatched line, we have a chemical bond

19 between that Plexar tie layer and the outer Pebax polyester

20 layer.

21 Q. Let's talk a little bit about that chemical bond. Can you

22 explain for us, from your perspective as a scientist and an

23 engineer, what exactly a chemical bond is?

24 A. Yes. There's a very specific chemical definition when we

25 say "a chemical bond." And those typically are comprised of


1 three different classes.

2 One is a covalent bond. That's where we share other

3 valence, valence electrons. A good example of that would be

4 carbon carbon in diamonds, obviously a very strong hard

5 material.

6 We can have ionic bonds, in which case we get

7 electron transfer from one charge to another. So a good

8 example of that would be sodium and chlorine, which we see in

9 salt, NACL.

10 And then we can have hydrogen bonding, which is

11 typically weaker but also a significant bond. And that

12 requires the presence of hydrogen to be present. And a good

13 example of that would be the dipoles that are created in water.

14 Hydrogen and oxygen create a hydrogen bond.

15 Q. And what kind of chemical bond do we have here?

16 A. Here we have Plexar, that again has functionalized groups,

17 and we have polyester. So we've got two polar groups, and we

18 would have expected covalent bonding on those yellow hatches.

19 Q. Now let's talk a little bit more about the inner layer,

20 the one that's made from high-density polyethylene or HDPE.

21 Can you explain for us in just simple terms what polyethylene

22 is.

23 A. Yes. Just to give us some household examples, probably

24 all of you have experienced dealing with polyethylene on a

25 day-to-day basis. Most trash bags are made of polyethylene.


1 Your shampoo bottles would be made of polyethylene.

2 Polyethylene is a polymer comprised of many chains.

3 And if we look at an individual chain, we would see the repeat

4 unit of the mer that's called ethylene. And so "poly" means

5 many, many ethylenes on a chain.

6 And then all those chains would be entangled together

7 into one large mass, which would be your solid. So when you

8 look at your shampoo bottle, it's not a single polymer chain.

9 It's the mass of entanglement of many, many chains that

10 provides that solid structure.

11 Q. I would like to explore this idea of the chains of

12 polyethylene being entangled together so that you have a

13 material that can form something like a bottle.

14 Is there something that you can think of in everyday

15 life that we can use to sort of visualize how this entanglement

16 of the chains works?

17 A. Sure. I think just the word entanglement has probably

18 meaning to everyone.

19 But when I teach my polymer class, when I'm trying to

20 get the sense of what it means to have chain entanglement, the

21 analogy I like to use is a very simple one.

22 We probably have all put Christmas tree lights up at

23 some point. Even if it's just for decoration. And so we rely

24 on those chains to give us nice little feature on the tree or

25 just for decoration. And then we take them off and we put them


1 in a box.

2 And, I don't know, most of us have experienced over

3 the course of the year -- I always think gremlins come in --

4 the box gets shaken, gets disturbed, and we go to take those

5 nice, long --

6 (Reporter interrupts.)

7 A. So we go to take these nice long chains of lights out of

8 the box, and they all become physically entangled.

9 And what happens, when we try to pull on these

10 chains, they are physically entangled and actually are

11 structurally tied to each other. So there's some real

12 structural integrity there.

13 Another good analogy is actually thermoplastic

14 elastomer rubber bands. So must most of our everyday rubber

15 bands are actually made of that polymer.

16 And, again, we have a lot of structural integrity.

17 We can take that rubber band, we can stretch it. It can

18 support a load. We are relying on that covalent bond -- sorry.

19 We are relying on that entanglement to essentially re-create

20 the same type of feature as a covalent bond.

21 Q. How strong a bond can you get from chain entanglement?

22 A. So as I just mentioned, looking at the elastomers, you can

23 get an equivalently strong bond as if you had had a covalent

24 bond. So it can be equivalent.

25 Q. All right. So we now understand what polyethylene is.


1 Let's move on and talk about high-density polyethylene. Can

2 you give us just a simple nontechnical explanation of what HDPE

3 is.

4 A. Okay. So polyethylene is a class of all polymers that are

5 made of -- made of ethylene chains.

6 High-density polyethylene has a very specific meaning

7 based on its density. It's typically one of the highest

8 densities of the whole polyethylene family. Meaning there is

9 more mass per volume than, say, low-density polyethylene.

10 So, you know, a simple analogy is looking at a brick

11 versus a same geometry of foam. One has got substantially

12 greater density.

13 So how efficiently those chains pack in space will

14 dictate the overall density of the polymers. The high-density

15 specifically means more efficiency of those chains packing in

16 space.

17 Q. Now, you told us about this chemical bond at the interface

18 between the outer Pebax layer and the Plexar tie layer.

19 There's another interface in our drawing that has these little

20 red Xs between the HDPE layer and the Plexar layer.

21 Is there a chemical bond that connects the Plexar

22 layer to the HDPE layer?

23 A. No. There is no chemical bond between the Plexar and the

24 high-density polyethylene.

25 What I've denoted here, instead, are these red Xs


1 that exist between the Plexar tie layer and the high-density

2 polyethylene inner layer.

3 And, again, those red Xs would denote those Christmas

4 tree light entanglements. That's where the polymer chains have

5 physically become entangled with the other polyethylene chains.

6 So if you'll recall, the Plexar is also predominantly

7 a polyethylene polymer. So you've got a lot of long chains

8 that are physically entangled and giving us a structural bond.

9 Q. Did you do any testing of the Maverick family of products

10 to try to figure out how strong the attachment is between the

11 Plexar tie layer and the HDPE inner layer?

12 A. Yes. Actually took one of these catheters and dissected

13 out a piece of this tubing, and then tried to pull apart the

14 inner high-density polyethylene away from the inner middle

15 layer, the Plexar.

16 So just focusing on these two, tried to physically

17 pull apart the Plexar from the high-density polyethylene. And,

18 again, had there been no entanglement or structural integrity

19 there, these would have easily separated and been indicative of

20 no structural bond.

21 Q. And what did you find when you tried to separate them?

22 A. I was unable to separate them with human force. And it

23 was my opinion that we had a structural bond there and that we

24 had good adhesion.

25 Q. Now, you said at the very outset that you focused in this


1 case on this question of infringement. And I understand you're

2 not a lawyer, but do you understand when you're trying to

3 decide whether a patent is infringed what part of the patent

4 you have to focus on?

5 A. Yes. As you've said, I'm not a lawyer. But it's my

6 understanding that we focus on the claims of the patent when

7 addressing infringement.

8 Q. How many claims have to be infringed in order for there to

9 be infringement?

10 A. Only one.

11 Q. Now, are you familiar with the term "literal

12 infringement"?

13 A. Yes. So literal infringement means literally that every

14 element of the claim is present in the feature of a product

15 that is infringing that claim.

16 Q. Now, you told us that you focused on Claim 7 of the

17 Fontirroche '594 patent. Have you brought along a chart that

18 has the text of Claim 7 in it?

19 A. I have.

20 Q. Would you refer to defendant's Exhibit 3015, and tell us

21 if that's your chart.

22 A. Yes.

23 MR. BAUMGARTNER: Your Honor, may we display DX-3015

24 for the jury?

25 THE COURT: Is there any objection?


1 MR. LEE: Just a second, Your Honor. As to 3015, no.

2 THE COURT: All right. You may display it.




6 Q. Professor Pruitt, let's go through the claim one part at a

7 time. It starts out, "An intravascular balloon catheter."

8 Are the products in the Maverick family of products

9 intravascular balloon catheters?

10 A. Yes, they are.

11 Q. Now, you told us that some of the products in the Maverick

12 family are bare metal stent delivery systems and drug-eluting

13 stent delivery systems.

14 How can a stent delivery system also be an

15 intravascular balloon catheter?

16 A. As I mentioned before, the balloon becomes the vehicle for

17 the stent delivery. So a stent is actually placed on the

18 balloon tip and then brought to the site of the lesion for

19 delivery.

20 Q. Let's go to the next part of the claim. It says there

21 that there is a "first flexible plastic tube defining a

22 guidewire lumen."

23 Do the Maverick family of products have that?

24 A. Yes, they all have the first flexible plastic tube or the

25 guidewire tube.


1 Q. Now, there is this phrase here defining a guidewire lumen.

2 Can you explain for us what that word lumen means?

3 A. Yes. Lumen just essentially means the opening. So it's

4 the opening space that's in the interior of that guidewire

5 tube.

6 And just a simple analogy is, if you took a role of

7 paper towels and you were to look down the cardboard tube, that

8 opening is the lumen for the paper towels.

9 Q. Let's go to the next part of the claim. It says that the

10 "said first tube being co-extruded of an outer plastic layer

11 and an inner plastic layer."

12 To start with, what tube are we talking about here?

13 A. So, again, this is the guidewire tube.

14 Q. Now, in the Maverick family of products is the guidewire

15 tube co-extruded?

16 A. Yes.

17 Q. Is there an outer layer and an inner layer in the

18 guidewire tube?

19 A. Yes. You'll probably recall from that cross-section we

20 looked at, we had an outer Pebax layer and an inner

21 high-density polyethylene layer.

22 Q. All right. Let's go on.

23 The claim says, "the plastic materials of said outer

24 and inner plastic layers being different and bonded to each

25 other."


1 Do you see that?

2 A. Yes, I do.

3 Q. Now, are the materials of the outer -- the outer layer and

4 the inner layer different?

5 A. Yes. As we've said, in the cross-section the outer layer

6 was a Pebax polyester and the inner layer is a high-density

7 polyethylene. So they are different.

8 Q. Are the materials of the Pebax outer layer and the HDPE

9 inner layer bonded to each other?

10 A. Yes, they are boned to each other.

11 Q. Now, can you explain for us how the Pebax outer layer and

12 the HDPE inner layer are bonded to each other?

13 A. Again, if we refresh our memories with that cross-section

14 that we looked at, we had an internal middle layer, which is a

15 Plexar layer. And so the bonding is achieved via this Plexar

16 middle layer.

17 So that light green polymer, which is polyethylene

18 based, provides a mechanism for a covalent bond to be achieved.

19 So we have a tie layer that provides that chemical bond.

20 Q. Now, is there any sort of commonplace product that we're

21 all familiar with that would use a similar mechanism to what we

22 see here?

23 A. Yes. When we think about two materials that are bonded to

24 each other but not touching, a simple analogy is to look at

25 brick and mortar as a model.


1 We have two bricks that are bonded to each other, and

2 we use mortar to achieve that bond.

3 Q. Let's go back to the Fontirroche patent itself. And let's

4 see if we can get Column 6, Line 12. And this is of DX-1 of

5 Cordis.

6 Could you refer, Professor Pruitt, to Column 6, Line

7 12 and just read for us the sentence that appears there.

8 A. It says, "More specifically, the material of inner plastic

9 layer 34 may be a high-density polyethylene modified, for

10 example, with the presence of about 1 or 2 mole percent of

11 copolymerized maleic and anhydride units. As previously

12 stated, such modified polyethylene resins are commercially

13 available under the Quantum Chemical Corporation under the

14 trademark Plexar, being used conventionally as tie layer" --

15 thank you -- "as tie layer resins for the bonding of dissimilar

16 plastics together in co-extruded film."

17 Q. Now, when it refers in this patent to dissimilar plastics,

18 what does that mean?

19 A. So, again, the dissimilar plastics would be, that outer

20 Pebax polyester material would be dissimilar from that inner

21 high-density polyethylene.

22 Q. All right. Now, let's move over to Column 3, line 9. And

23 could you read for us the sentence that appears there, please.

24 A. Yes. It starts, "Preferably the functional plastic

25 material is not used to bond two dissimilar layers together but


1 rather making use of the material in its own right for its

2 desired characteristics."

3 Q. Can you give us an example of the functional plastic

4 material that is referred to in this sentence?

5 A. Yes. So the functional plastic material that's referred

6 to here would be covered by the description we've just read on

7 the Plexar, the functionalized polyethylene.

8 Q. What did the inventors mean when they said that preferably

9 the functional plastic material is not used to bond two

10 dissimilar layers together?

11 MR. LEE: I object.

12 THE COURT: Sustained to the form.


14 Q. What is your understanding, from reading the

15 specification, as to what it means when it says "preferably the

16 functional plastic material is not used to bond two dissimilar

17 layers together"?

18 MR. LEE: Well, Your Honor, I have no objection to

19 the substantive question, but I think the question is what it

20 would have been to one of ordinary skill in the art back in

21 1991. If that's the question --

22 THE COURT: Do you accept the amendment?

23 MR. BAUMGARTNER: Yes, Your Honor, I do.

24 THE COURT: Why don't you say it then all together.

25 MR. BAUMGARTNER: All right.



2 Q. From the standpoint of a person of ordinary skill when the

3 invention was made, what would this language, preferably the

4 functional plastic material that's not used to bond two

5 dissimilar layers together, what would that mean as you

6 understand it?

7 A. Uhm, the way that that language would read would be that

8 preferably you would use that functionalized material in its

9 own right as a layer.

10 And that a nonpreferred embodiment could then be that

11 you would use that functionalized material, that Plexar

12 material, as a tie layer to bond two dissimilar materials.

13 MR. BAUMGARTNER: Could we go back to Exhibit 3015,

14 please.



17 Q. Now, when the claim refers to the outer and inner plastic

18 layers being different and bonded to each other, is a

19 particular kind of bond required?

20 A. The Court has construed "bonded" to mean a chemical bond.

21 MR. BAUMGARTNER: May we ever DX-3014 again, please.



24 Q. Is there a chemical bond that helps to connect the outer

25 plastic layer to the inner plastic layer?


1 A. Yes. As I've said earlier, the chemical bond is denoted

2 by the yellow hatch marks. So that's the covalent bond that's

3 achieved between the Plexar and the Pebax.

4 Q. Now, we talked just a minute ago about how the patent

5 specification talks about the use of a tie layer as a

6 nonpreferred embodiment.

7 Where a tie layer is used in that manner, where would

8 the chemical bond normally be located?

9 A. So if we're using this tie layer, we would have the

10 chemical bond between this tie layer and the outer Pebax layer.

11 Q. Now, we talked earlier about literal infringement. In

12 order for there to be literal infringement of Claim 7, does

13 there need to be a chemical bond between the Plexar layer and

14 the HDPE layer?


16 THE COURT: It's a legal --

17 MR. LEE: Conclusion.

18 THE COURT: -- conclusion. Sustained.


20 Q. In order for the inner layer and the outer layer to be

21 bonded to each other through the use of a chemical bond, does

22 there need to be a chemical bond between the Plexar layer and

23 the HDPE layer?





2 Q. Uhm, let's suppose, just hypothetically, that the claim

3 were interpreted to require a chemical bond between the Plexar

4 layer and the HDPE layer. Can you assume that?

5 A. I can.

6 Q. Now, making that assumption, would there be literal

7 infringement by the Maverick family of products?

8 A. If, hypothetically, we required a chemical bond between

9 the Plexar, the lighter green, and the inner layer, the

10 high-density polyethylene, then we would not have literal

11 infringement.

12 Q. Now, is there a way to have infringement of a patent claim

13 other than literal infringement?

14 A. Yes. Again, I'm not a patent attorney, but it's my

15 understanding that there's another way to satisfy infringement.

16 Q. And what is that?

17 A. Uhm, there's a terminology entitled "doctrine of

18 equivalents," which essentially says if something is not

19 literally present in that claim but it's insubstantially

20 different or prefers substantially the same function in

21 substantially the same way, giving you substantially the same

22 result, then you still have infringement under the doctrine of

23 equivalents.

24 Q. Now, making our assumption about how you would need the

25 two different chemical bonds, making that assumption that the


1 claim would require that, have you prepared a chart to

2 summarize how the doctrine of equivalents would apply, making

3 that assumption?

4 A. Yes. I have a chart that looks at the doctrine of

5 equivalents for this situation.

6 Q. Could you take a look at Defendant's Exhibit 3012, and

7 tell us if that's your chart.

8 A. Yes, it is.

9 MR. BAUMGARTNER: Your Honor, may we display DX-3012?

10 MR. LEE: Your Honor, I object to this chart which we

11 got yesterday, for the reasons previously stated.

12 THE COURT: Right. And those are overruled.

13 And there are no other objections, Mr. Lee?

14 MR. LEE: Not to the chart, Your Honor.

15 THE COURT: Okay. You may display it.




19 Q. Let's go through this quickly, Professor Pruitt.

20 What is the function of the chemical bond in the

21 Fontirroche patent?

22 A. As you see here, the function of the chemical bond in the

23 Fontirroche patent allows for the formation of the multi-layer

24 guidewire tube.

25 Q. And what function is served by the entanglement bond


1 between the Plexar layer and the HDPE layer in the Maverick

2 family guidewire tube?

3 A. Again, also, the entanglement provides the same function.

4 It allows the formation of a multi-layer guidewire tube.

5 Q. What is the way that the chemical bond in the Fontirroche

6 patent works?

7 A. The way that the chemical bond in the Fontirroche patent

8 works is that it holds the layers together so they cannot be

9 separated.

10 Q. Is that true of the entanglement bond between the Plexar

11 layer and the HDPE layer?

12 A. Yes. Entanglement between the Plexar layer and the

13 high-density polyethylene also holds those layers together so

14 that they cannot be separated.

15 Q. And are you pretty sure about that?

16 A. Yes. As I've said, I have tried to dissect this apart,

17 and that's my opinion.

18 Q. Finally, what is the result of the chemical bond in the


20 A. The result of the chemical bond in the Fontirroche patent

21 is that we end up with a guidewire tube that does not

22 delaminate. It doesn't come apart under force.

23 Q. Is substantially the same result achieved with the

24 entanglement bond between the Plexar layer and the HDPE layer?

25 A. Yes. The entanglement bond between that tie layer and


1 that inner layer gives us the same results that the guidewire

2 tube is a structurally intact tube that does not delaminate.

3 MR. BAUMBARTNER: Let's go back to Defendant's

4 Exhibit 3015, please.


6 Q. The next part of the claim says:

7 "Said guidewire lumen being adapted to slidingly

8 receive a guidewire."

9 Is that true of the Maverick family of products?

10 A. Yes, it is.

11 Q. Can you tell us, again, what the guidewire lumen in is?

12 A. So that guidewire lumen is, again, it's the opening on the

13 inside of the guidewire tube.

14 Q. And what does it mean for that to be adapted to "slidingly

15 receive a guidewire"?

16 A. As you see in, actually, Mr. Liang's talk, you need to

17 transport a guidewire through this inner tube and so it's

18 important that we slidingly; in other words, you can slide that

19 guidewire readily through this tube.

20 Q. Can a guidewire slide inside the guidewire tube of the


22 A. Yes.

23 Q. Let's go to the next part of the claim.

24 It says:

25 "Wherein the material of said inner plastic layer


1 includes at least a majority of high density

2 polyethylene."

3 Can you remind us, again, what the inner plastic

4 layer is in the guidewire tube of the Maverick family of

5 products?

6 A. Yes. You will recall that that inner layer would be a

7 100 percent high density polyethylene layer.

8 Q. So is that part of the claim satisfied?

9 A. Yes.

10 Q. Let's go to the next part of the claim. It says:

11 "Said material of the inner plastic layer being

12 more flexible and exhibiting a more lubricious

13 surface than the material of said outer plastic

14 layer."

15 Let's focus on the flexibility requirement first. Is

16 that requirement satisfied with the Maverick family of

17 products?

18 A. Yes, it is.

19 Q. And explain to us what you did to study flexibility in

20 this context?

21 A. Okay. Flexibility -- and I will have a demonstrative in a

22 few minutes, but the flexibility is a geometric property. So

23 it's a function of the flexual modulus of the material and the

24 geometry of that material that's involved.

25 So we took tubes of the outer layer, the Pebax, and


1 the inner layer, the high density polyethylene, of the same

2 geometry that's used in the catheter design and we looked at

3 what the flexual modulus was for that material. We looked at

4 the moment of inertia or the geometric parameter for that tube

5 and calculated out what the stiffness of that material would

6 be.

7 When something is stiff, it is not flexible. They

8 are inverse relationships. And we were able to determine that

9 the inner material, the high density polyethylene, was, in

10 fact, less stiff or more flexible than the outer Pebax layer.

11 Q. So this is a calculation you learned how to do in

12 engineering school?

13 A. The calculation that we used is as a standard strength of

14 materials formulation, that couples the modulus and the moment

15 of inertia to give you a geometric property, such as stiffness

16 or flexibility.

17 Q. Now, when you do this calculation, do you focus on the

18 material in isolation or do you look at how flexible the

19 material is in the tube form as it exists in the guidewire

20 tube?

21 A. Because flexibility is a geometric property, you actually

22 have to look at it in the context of the geometry that you

23 would find it in within the tube.

24 Q. Let's take a look at the patent again and turn to column

25 5, line 38. This is DX-1 again.



2 Q. Could you read for us the two sentences that appear there,

3 please?

4 A. Yes. It reads:

5 "The outer tubular plastic layer, 32, of catheter

6 tube, 20, may preferably be selected from the group

7 consisting of nylon, polyurethane and polyester, with

8 such materials typically being of greater stiffness

9 than the material of inner tubular plastic layer, 34.

10 Outer plastic layer, 32, may typically comprise about

11 60 to 90 percent of the overall wall thickness of

12 tube, 20, providing a desired amount of stiffness to

13 the tube, while tube, 20, retains a thin wall."

14 Q. Is this part of the patent specification important to the

15 analysis of flexibility?

16 A. It's my interpretation that it's extremely important, as

17 it tells us here that the outer tubular layer is being

18 equivalated to the material.

19 And, more importantly, it's reaffirming that

20 stiffness is tied to the geometric property. We are seeing

21 here specifications to the overall thickness of the tube and

22 the overall constituency of that thickness.

23 Q. As a matter of basic engineering, is the patent correct

24 when it suggests that stiffness is affected, in part, by the

25 thickness of a materials?


1 A. Yes.

2 Q. Did you bring along some everyday materials to illustrate

3 this point?

4 A. I did. I brought some just basic materials I thought

5 might be useful in illustrating flexibility, and I will bring

6 those out.

7 Q. Why don't you show us what you have?

8 (Brief pause.)

9 A. Okay. So with me I have aluminum in a variety of forms.

10 This is the same alloy. It's a 6061 alloy. And it comes in

11 same lengths, different diameters, so a different cross

12 section.

13 And one of the things that's extremely important and

14 then we will make the example as we go to polyethylene,

15 something we have all seen, which would be aluminum foil.

16 As we progress in thickness, one of the things that

17 we would find is if I took a relatively small diameter tube, I

18 would actually just under force of hand be able to get

19 flexibility. I actually would be able to get a little bit of

20 bend (indicating) and it gets recovered.

21 That's what we mean by flexibility. This is the same

22 material. It has the same flexual modulus. The modulus is a

23 material property. Flexibility is a geometric property.

24 If I move to a slightly larger diameter, I don't have

25 the physical strength any more to get flexibility. Someone in


1 the room might get a little bit of flex, but I would question

2 if anyone out there wants to try to put some flex in the larger

3 diameter.

4 And, in fact, we saw a little bit of this in the

5 catheter design by Mr. Liang when he talked about making a

6 balloon flexible by changing the thickness. You make it

7 thinner, you make it more flexible.

8 So just by changing very simple geometry, I'm able to

9 move this from a relatively flexible material to a rigid type

10 material. And then if I take the geometric limit and move this

11 to a thin form, I can make it extremely flexible (indicating).

12 So, again, it's the same material modulus, but I'm

13 able to change the flexibility just with geometry.

14 Q. Let's go back to the claim language and take a look again

15 at Defendant's Exhibit 3015.


17 Q. Now, the same part of the claim that we were talking about

18 also refers to how, "the inner layer will have a more

19 lubricious surface than the material of the outer plastic

20 layer." What does "lubricious" mean?

21 A. Again, I think this is a term that you have heard earlier

22 today, but "lubricious" means slippery. It's how easy it is to

23 move one material past the other. So something that's very

24 slippery is lubricious. Teflon-coated pans are lubricious.

25 Q. No, is the HDPE inner layer more slippery, more lubricious


1 than the Pebax outer layer?

2 A. Yes. Polyethylene, high density polyethylene is known for

3 being a lubricious or slippery material. In fact, we often use

4 polyethylene in things like the bottoms of our snowboards,

5 because it's lubricious, slippery.

6 Q. Now, did you do any testing just to make sure that the

7 HDPE layer was more slippery than the Pebax outer layer?

8 A. Yes, I did.

9 Q. Can you tell us what your testing involved?

10 A. This testing actually involved a standard test that is

11 used by Cordis engineers. In this case, again, we made tubes

12 of the materials in question, so the high density polyethylene

13 and that Pebax polyester.

14 We made them of the distal geometry of the catheter

15 tube, so they had the same geometry, and we ran these -- we

16 actually set up a helical coil of this guidewire tube and then

17 we ran a guidewire through that helical tube and measured the

18 force that it would take to --

19 Q. Let me interject. A helical coil is like a corkscrew?

20 A. Yes.

21 Q. Okay.

22 A. So it got essentially a twist to try to mimic what would

23 happen in the curvature of the vasculature.

24 And then we monitor the force that it takes to move

25 the guidewire through that lumen, through that guidewire tube.


1 The more force that it takes, means the more

2 resistant that material is, the less slippery the less

3 lubricious. The more slippery the more lubricious that

4 material is, the easier it is to move that guidewire through.

5 And so those findings revealed that the high density

6 polyethylene was, in fact, more lubricious, more slippery than

7 the Pebax material, the polyester.

8 Q. Let's go to the next part of the claim. It says:

9 "And the material of said outer plastic layer

10 being selected from the group consisting of nylon,

11 polyurethane and polyester."

12 Is the Pebax outer layer made from one of those

13 materials.

14 A. Yes. As I have said earlier, the Pebax material is

15 actually a polyester polymer.

16 Q. Now, is there a particular definition of polyester that

17 you used for your analysis here?

18 A. Yes. The definition that I used was the one issued by the

19 Court.

20 Q. Did you bring along a chart showing the definition?

21 A. Yes. I have a picture demonstrating that.

22 Q. Is that DX-3013?

23 A. Yes.

24 MR. BAUMBARTNER: Your Honor, may we display that to

25 the jury?



2 MR. LEE: No objection.

3 THE COURT: You may.


5 BY MR. BAUMBARTNER:

6 Q. Would you read for us the definition of polyester that you

7 used?

8 A. Yes. The Court's definition is:

9 "Polyester is a condensation polymer that

10 contains ester groups as inter-unit linkages in its

11 principal chemical chain. Polyester is not limited

12 to homopolymers, but embraces copolymers such as

13 Hytrel."

14 Q. Using that definition, is Pebax a polyester?

15 A. Yes. The Pebax polymer actually has linkages of ester in

16 its backbone.

17 Q. Let's go back to the claim language. It continues:

18 "A second flexible plastic tube surrounding said

19 first tube and defining an inflation lumen between

20 the outer surface of the first tube and the inner

21 surface of the second tube."

22 Do the Maverick family of products have that?

23 A. Yes, they all have this component.

24 Q. Now, what is the second tube? What is that?

25 A. That is the outer tube that enables the inflation process.


1 Q. Would that be called the inflation tube or --

2 A. Yes.

3 Q. (Continuing) -- the shaft?

4 A. The shaft.

5 Q. All right. Now, what does this inflation tube or shaft

6 do?

7 A. I think you might have even seen some of this in

8 Mr. Liang's demonstration, but it enables some structural

9 rigidity and, also, provides a coupling for the inflation to

10 occur to the balloon.

11 Q. And what goes through the inflation tube?

12 A. So that inflation, actually, we use a fluid to --

13 externally as a source to do the inflation of the balloon

14 inside the body.

15 Q. Now, the claim language uses the phrase "inflation lumen."

16 What does that mean?

17 A. Again, this would be an opening that enables that

18 inflation process to occur. So the lumen would be that inner

19 opening.

20 Q. In the Maverick family of products is the inflation lumen

21 located between the outer surface of the first tube and the

22 inner surface of the second tube?

23 A. Yes, they are.

24 Q. Let's go finally to the last part of the claim. It says:

25 "A flexible balloon having a distal end coupled


1 to said first tube and a proximal end coupled to said

2 second tube such that the interior volume of the

3 balloon is in fluid communication with said inflation

4 lumen."

5 Is that part of the claim present in the Maverick

6 family of products?

7 A. Yes, it is.

8 Q. Now, what is the balloon on the Maverick family of

9 products made from?

10 A. Balloon is made of the same polymer as the outer layer, so

11 it's a Pebax polymer.

12 Q. Is Pebax flexible?

13 A. Yes, in that geometry it is flexible.

14 Q. Now, what is the distal end of the balloon?

15 A. The distal end is the end furthest from the cardiologist,

16 the word distal.

17 Q. Now, is that end of the balloon coupled to the guidewire

18 tube?

19 A. Yes, it is.

20 Q. What is the proximal end of the balloon?

21 A. Proximal end would be the end that is actually closest to

22 the cardiologist.

23 Q. Is that end of the balloon coupled to the inflation tube

24 in the Maverick family of products?

25 A. Yes, it is.


1 Q. What does it mean to say that, "The interior volume of the

2 balloon is in fluid communication with the inflation lumen"?

3 A. Again, as I just stated, it means that they were able to

4 use that fluid, the fluidization through that lumen to do the

5 inflation of the balloon tip on the distal end of this catheter

6 tube.

7 Q. So the liquid goes through that inflation lumen and is

8 used to pump up the balloon?

9 A. That is correct.

10 Q. All right. Now, I think we are at the end of the claim,

11 so let's sum up.

12 For the Maverick family of products is every part of

13 Claim Seven of the '594 patent literally present?

14 A. Yes.

15 Q. What conclusion do you draw about the infringement of

16 Claim Seven of the '594 patent by the Maverick family of

17 products?

18 A. It's my opinion that the Maverick family literally

19 infringes and infringes on Claim Seven of the '594 patent.

20 MR. BAUMBARTNER: Thank you, Professor Pruitt. I

21 have no further questions.

22 THE COURT: Thank you.

23 (Witness steps down.)

24 THE COURT: And that brings us, ladies and gentlemen,

25 to the end of our day and it brings you to the end of our week.

PROCEEDINGS 641

1 We will not have court for this jury trial tomorrow.

2 I have other matters I have to hear in the courtroom, so this

3 begins your weekend from me anyway.

4 I would like to see you back here, please, at 8:30

5 Monday morning. We will go Monday, Tuesday, Wednesday,

6 Thursday next week, but then only Monday, Tuesday the following

7 week.

8 In the meantime, we will be apart for three days, so

9 I know that people will be curious to know what you are doing,

10 what you are up to. It's the weekend. You will be seeing

11 people.

12 Once again, I urge you, you may not speak with anyone

13 about this case. Don't tell them about it. Don't let them ask

14 you about it. Don't look up anything about it. Don't look in

15 dictionaries or on the internet. Don't do any research. It's

16 important that everybody decide the case based simply on the

17 evidence that you hear in this courtroom.

18 Have a great weekend. I will see you 8:30 Monday

19 morning.

20 (Jury out 3:00 p.m.)

21 THE COURT: So what is up for Monday morning?

22 MR. PRITIKIN: I think our next witness, your Honor,

23 is going to be Dr. David Roberts. And then we had thought we

24 would play a deposition after that, but that was based, in

25 part, on not knowing when we were going to finish today.

653

1 I N D E X

2 PLAINTIFF'S WITNESSES PAGE VOL. 3 MEYER, PAUL 4 Direct Examination Resumed by Mr. Selwyn 431 3 Cross Examination by Mr. Baumgartner 450 3 5 Redirect Examination by Mr. Selwyn 509 3 Recross Examination Resumed by Mr. Baumgartner 518 3 6

7 - - - -

8 DEFENDANT'S WITNESSES PAGE VOL. 9 LIANG, SAMUEL10 (SWORN) 525 3 Direct Examination by Mr. Pritikin 526 311 Cross Examination by Mr. Lee 561 3 Redirect Examination by Mr. Pritikin 597 312 Recross Examination by Mr. Lee 597 3

13

14 PRUITT, LISA ANN (SWORN) 599 315 Direct Examination by Mr. Baumgartner 599 3

16

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18

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25

654

1

2 E X H I B I T S 3

4 PLAINTIFF'S EXHIBITS IDEN VOL. EVID VOL.

5 201, 265, 266, 267, 304 525 3 391, 461, 463, 590, 600 525 3 6 604, 673, 844, 962 525 3 577 433 3 7 844 491 3

8

9

10 DEFENDANT'S EXHIBITS IDEN VOL. EVID VOL.

11 Following exhibits admitted conditionally: 22, 23, 30, 38, 39, 40 646 312 47, 59, 62, 64, 71, 90 646 3 95, 105, 107, 111, 112 646 313 168, 176-A, 177, 358 646 3 360, 413, 745, 819, 868 646 314 951, 960, 1579, 1642 646 3 2107-A, 2112, 2115, 2116 646 315 2278, 2336, 2366, 2367 646 3 PTX-33 646 316

17

18 _ _ _ _

19

20

21

22

23

24

25

655

1

2

3 CERTIFICATE OF REPORTER

4 I, DEBRA L. PAS, Official Reporter for the United

5 States Court, Northern District of California, hereby certify

6 that the foregoing proceedings in 02-0790 SI, BOSTON SCIENTIFIC

7 CORPORATION, et al versus JOHNSON & JOHNSON, et al, were

8 reported by me, a certified shorthand reporter, and were

9 thereafter transcribed under my direction into typewriting;

10 that the foregoing is a full, complete and true record of said

11 proceedings as bound by me at the time of filing.

12 The validity of the reporter's certification of said

13 transcript may be void upon disassembly and/or removal

14 from the court file.

15

16

17 ________________________________________

18 Katherine A. Powell, CSR 5812, RMR, RPR

19

20

21 ________________________________________

22 Debra L. Pas, CSR 11916, CRR, RMR, RPR

23 Thursday, October 11, 2007

24

25

THIS PAGE INTENTIONALLY LEFT BLANK EXCEPT FOR THESE WORDS...

THIS IS THE BREAK BETWEEN DAY 3 AND DAY 4.

655

1 Volume 4

2 Pages 655 - 891

3 UNITED STATES DISTRICT COURT

4 NORTHERN DISTRICT OF CALIFORNIA

5 BEFORE THE HONORABLE SUSAN ILLSTON

6 BOSTON SCIENTIFIC CORPORATION, ) et al., ) 7 ) Plaintiffs, ) 8 ) VS. ) No. C 02-0790 SI 9 ) JOHNSON & JOHNSON and CORDIS )10 CORPORATION, ) ) San Francisco, California11 Defendants. ) Monday ) October 15, 200712 ___________________________________) 8:39 a.m. )13 CORDIS CORPORATION, ) )14 Counterclaim-Plaintiff, ) )15 VS. ) )16 BOSTON SCIENTIFIC CORPORATION, ) et al., )17 ) Counterclaim-Defendants. )18 ___________________________________)

19 TRANSCRIPT OF PROCEEDINGS

20 APPEARANCES:

21 For Plaintiffs: Wilmer Cutler Pickering Hale and Dorr 60 State Street22 Boston, Massachusetts 02109 By: William F. Lee, Esquire23 Dominic E. Massa, Esquire

24 (Appearances continued on next page)

25 Reported By: Katherine A. Powell, RPR, CRR, CSR No. 5812 Debra L. Pas, RMR, CRR, CSR No. 11916

656

1 Appearances continued:

2 For Plaintiffs: Wilmer Cutler Pickering Hale and Dorr 1117 California Avenue 3 Palo Alto, California 94304 By: Mark D. Selwyn, Esquire 4

5 For Defendants: Sidley Austin LLP One South Dearborn 6 Chicago, Illinois 60603 By: David T. Pritikin, Esquire 7 William H. Baumgartner, Jr., Esquire

8 Johnson & Johnson One Johnson & Johnson Plaza 9 New Brunswick, New Jersey 08933 By: Eric I. Harris, Esquire10

11

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13

14

15

16

17

18

19

20

21

22

23

24

25

657

1 P R O C E E D I N G S

2 OCTOBER 15, 2007 8:39 A.M.

3

4 (The following proceedings were held in open court,

5 outside the presence of the jury.)

6 THE COURT: Good morning.

7 ALL COUNSEL: Good morning.

8 THE COURT: You may be seated. Are we ready?

9 MR. LEE: Yes.

10 THE COURT: Now, what's up next?

11 MR. LEE: I think I'm going to cross-examine

12 Dr. Pruitt.

13 THE COURT: All right. Okay. And then we have

14 the --

15 MR. PRITIKIN: Yes, I can tell Your Honor what's

16 happening today. After Professor Pruitt will be Dr. Roberts,

17 Ms. --

18 THE COURT: He's live?

19 MR. PRITIKIN: Yes.

20 THE COURT: Okay.

21 MR. PRITIKIN: And Ms. Robinson live. Then we have a

22 couple of depositions, Krieger and Wilkins.

23 THE COURT: I gave Tracy the corrections to Krieger

24 and Wilkins Friday night, but I don't think we've shared them

25 with you yet. Not corrections, responses to objections.

658

1 She'll get those to you this morning.

2 MR. PRITIKIN: Won't be a problem. We can plug those

3 in today.

4 THE COURT: You don't think we're going to do

5 Kastenhofer today?

6 MR. PRITIKIN: I think it's doubtful. There are some

7 issues there, but I suggest we take this up either at lunch or

8 at the end of the day.

9 MR. LEE: Right.

10 THE COURT: Tracy.

11 (Jury enters at 8:41 a.m.)

12 THE COURT: Welcome, back ladies and gentlemen. You

13 may be seated.

14 All right. We'll give the witness the oath again,

15 since it's been a few days since we were last together.

16 THE CLERK: Just raise your right hand.

17 LISA PRUITT,


19 duly sworn, was examined and testified further as follows:


21 THE COURT: Okay. Mr. Lee.

22 MR. LEE: Thank you, Your Honor.

23 Could we have a moment to distribute the binders? I

24 think we have one for your Honor, as well.

25 THE COURT: Oh, sure.

659

1 CROSS EXAMINATION

2 MR. LEE: Your Honor, just to clarify, this is the

3 beginning of the cross-examination.

4 THE COURT: Right.

5 MR. LEE: Okay.

6 BY MR. LEE:

7 Q. Good morning, Dr. Pruitt.

8 A. Good morning.

9 Q. Dr. Pruitt, you testified about the Fontirroche patent

10 last Thursday, correct?


12 Q. Now, you used some materials when you testified, correct?


14 Q. You understand the difference between a real exhibit and a

15 demonstrative exhibit?

16 A. Yes, I do.

17 Q. All right. The demonstrative exhibits were some of the

18 charts you put on the screen to illustrate points, correct?


20 Q. The real exhibits are the materials that are real exhibits

21 and will go to the jury, that they can use to make their

22 decisions, correct?

23 A. It goes to the best of my understanding, that's correct.

24 Q. Fair enough.

25 Now, Dr. Pruitt, the only real exhibit you used in

660

1 your entire testimony was DX-1, the Fontirroche patent,

2 correct?

3 A. I guess I'm unclear about the legal aspects of the -- of

4 my demonstratives.

5 Q. Sure. Let me break it down this way. You did use DX-1,

6 the Fontirroche patent, correct?


8 MR. LEE: And could we have that placed on the

9 screen?

10 Your Honor, we would offer DX-1, the Fontirroche

11 patent.

12 MR. BAUMGARTNER: No objection.

13 THE COURT: Isn't it already in?

14 MR. LEE: No.

15 THE COURT: Well, if it's not, you don't object?

16 MR. BAUMGARTNER: I certainly don't.

17 THE COURT: It will be received.

18 (Defendant's Exhibit DX-1 received in evidence)


20 BY MR. LEE:

21 Q. In addition to the Fontirroche patent, I want to ask you

22 about the materials you used for with your opinion to the jury.

23 You didn't use any materials that showed the Boston

24 Scientific catheter, correct, other than your demonstratives?

25 A. I guess, in asking your question are you referring to my

661

1 flexibility demonstration?

2 Q. No. I'll be even more precise.

3 Did you show to the jury the design specifications

4 for the Boston Scientific product?

5 A. I did not put up the very specific design for individual

6 products, no.

7 Q. Did you show to the jury the manufacturing specifications

8 for the products?

9 A. No, I did not give you the very specific manufacturing

10 specs; just demonstratives.

11 Q. Right.

12 A. Yes.

13 Q. But you did look at those, correct?

14 A. Yes, I have looked at the engineering drawings and the

15 basic specs for these devices.

16 Q. Now let's talk about the Fontirroche patent. You

17 testified about how a person of ordinary skill in the art would

18 interpret portions of that patent.

19 Do you remember that?

20 A. Yes, I do.

21 Q. Would you tell us, Dr. Pruitt, who was the person of

22 ordinary skill in the art in January of 1994? What were their

23 qualifications?

24 A. By my understanding, a person of ordinary skill in the art

25 would have had an engineering education, would have had

662

1 expertise in the catheter design industry, basic experience in

2 materials engineering.

3 Q. In January 1994, you had just received your doctoral

4 degree, correct?

5 A. I finished my Ph.D. in '93, yes.

6 Q. Were you a person of ordinary skill in the art in

7 January 1994?

8 A. In January of 1994, I was not a catheter designer.

9 Q. So in January 1994, you would not have satisfied the

10 definition of one of ordinary skill in the art, correct?

11 A. At that specific time frame, no, I would not.

12 Q. So I want to ask you a few more questions then about your

13 testimony to the jury about how someone who was one of ordinary

14 skill in the art in January 1994, would have understood the

15 patent.

16 Mr. Fontirroche, you know who that is, correct?

17 A. Yes, I do.

18 Q. He was a person of ordinary skill in the art in

19 January 1994, correct?

20 A. That is my understanding, yes.

21 Q. But as of the time you formed your opinions, you had never

22 talked to him, correct?


24 Q. You've never talked to him, have you?

25 A. I have never spoken with Mr. Fontirroche.

663

1 Q. And you've never asked to speak to Mr. Fontirroche,

2 correct?


4 Q. So when you explained to the jury the meaning of the

5 patent specification, you hadn't asked Mr. Fontirroche what his

6 own words meant, correct?

7 A. No, I relied on reading the patent alone.

8 Q. Now, you described to the jury the specification portion

9 of the patent. Do you remember that?

10 A. Yes, I do.

11 Q. And you said that was a portion of the patent before the

12 claims. Do you remember that?

13 A. Yes, I referred to specifications within the patent before

14 the claim.

15 Q. Now, would you tell the jury, how does that portion of the

16 patent specification compare to the application that was

17 actually filed in January 1994?

18 A. I'm not sure what you mean by your question.

19 Q. Dr. Pruitt, you know an application was filed in

20 January 1994, correct?

21 A. That is my understanding.

22 Q. You have reviewed it, have you not?

23 A. I believe so.

24 Q. Right. And isn't it true that the January 1994

25 application is virtually identical in words to the

664

1 specification that you described to the jury; isn't that true?

2 A. To the best of my recollection, that would be true.

3 Q. So the words that you were interpreting for the jury, from

4 the prospective of one of ordinary skill in the art, were

5 Mr. Fontirroche's and his lawyer's words, correct?

6 A. That would be correct.

7 Q. But you were here last Thursday when we learned from

8 Mr. Liang that Mr. Fontirroche is not going to come and

9 testify, correct?

10 A. I don't know that personally.

11 Q. But as far as you know, the jury is not going to get to

12 hear what Mr. Fontirroche says the words you've put on the

13 screen mean, correct?

14 A. Again, I don't really know who is going to be called.

15 Q. Fair enough.

16 Mr. Trotta, was he a person of ordinary skill in the

17 art in January of 1994?

18 A. Yes, I would say Mr. Trotta is also a person of ordinary

19 skill as of 1994.

20 Q. And did you ever talk to Mr. Trotta about the meaning of

21 the words in the patent?

22 A. I've met with Mr. Trotta and spoken to him. I don't know

23 that we specifically discussed the meanings of the words in the

24 patent.

25 Q. Did you have any conversations with anyone who was a

665

1 person of ordinary skill in the art in January 1994, about the

2 meanings -- the meaning of the words of the patent?

3 A. Well, in 1994, I didn't have any conversations. The only

4 person I would have spoken to specifically would have been

5 Mr. Trotta, and not specifically to the words in the patent.

6 Q. Right. So is the answer to my question -- I'm asking you

7 to focus on the person of ordinary skill in the art. Do you

8 have that in mind?

9 A. Yes.

10 Q. And I'm asking you to focus on that person in 1994. Do

11 you have that in mind?

12 A. I do.

13 Q. And my question to you was, did you in preparing to give

14 your opinion to this jury, talk to anybody who was that person

15 of ordinary skill in the art in the year 1994, about what the

16 patent meant?

17 A. No, not about what the patent meant specifically, no.

18 Q. Now, you understand that Boston Scientific -- Were you

19 here during Mr. Liang's testimony?

20 A. Yes, I was here for Mr. Liang's testimony.

21 Q. And at the end there was questions about whether Boston

22 Scientific challenged the validity of the Fontirroche patents,

23 and some other questions.

24 Do you remember that generally?

25 A. I remember that generally, yes.

666

1 Q. Now, you do understand that Boston Scientific challenges

2 the proposition that it infringes the claims of the Fontirroche

3 patent, correct?

4 A. That's my basic understanding.

5 Q. Sure. And that's why you're here, in part, to help us

6 understand what Cordis's position is, correct?

7 A. I'm here to assess whether the Boston Scientific products

8 infringe on Claim 7 of the '594 patent.

9 Q. And in the process of giving your opinion on this issue

10 which Boston Scientific disputes, you referred the jury to

11 specific portions of the specification of the patent, correct?

12 A. Yes, I referred them to specific places within the '594

13 patent.

14 Q. Right. Portions to the patent that if Mr. Fontirroche and

15 Mr. Trotta were here, they might tell us, they might explain to

16 us what they thought it meant, correct?

17 A. I can't say specifically what they would testify to.

18 Q. Now, Dr. Pruitt, are you being compensated for your time

19 in the case?

20 A. Yes, I am.

21 Q. At what rate?

22 A. $400 an hour.

23 Q. And how many hours have you spent working on the case from

24 the day you first got hired to today?

25 A. I don't recall the exact number.

667

1 Q. Can you give us an approximate number?

2 A. Less than 100 hours, would be my guess.

3 Q. Now, other than talking to Mr. Trotta -- and I take it

4 that you can't remember specifically what you discussed with

5 him, correct?

6 A. I recall on that day we looked at the processing and some

7 of the aspects of development of materials for the catheter

8 design, but I don't recall the specific conversations, no.

9 Q. Okay. Other than talking to Mr. Trotta and to lawyers,

10 did you talk to anybody else to investigate or do the research

11 that lead to your opinion?

12 A. There were a few other scientists when I visited Cordis.

13 I do not recall their names. And I've also had conversation

14 with Pat Davis-Lemessy about some of the testing at Cordis.

15 Q. And that's it, correct?

16 A. That is -- the best of my knowledge, that is it, yes.

17 Q. Now, have you ever designed a balloon angioplasty

18 catheter?

19 A. I have not personally denied a balloon angioplasty

20 catheter, no.

21 Q. Have you ever performed a co-extrusion?

22 A. I have not personally performed a co-extrusion.

23 Q. Have you ever seen a co-extrusion performed?

24 A. I believe I have seen a co-extrusion, just in a basic lab

25 environ, but not specific --

668

1 Q. Have you ever seen a co-extrusion performed at a

2 manufacturing process?

3 A. I've -- I actually would like to correct my previous

4 answer.

5 I've seen co-extrusion in the context of

6 manufacturing the co-extruded tube, when I visited the Cordis

7 plant.

8 Q. So for the Boston Scientific product, how many hoppers are

9 used to produce the co-extruded tube for the Maverick?

10 A. I have never seen the Boston Scientific manufacturing

11 process in person.

12 Q. Well, is it one? Is it two? Is it three? Or is it more?

13 A. To the best of my knowledge, I would -- I would estimate

14 that it would be three.

15 Q. Right. It would be three because there is one for each

16 level, correct?

17 A. There's one for each starting material.

18 Q. Right. Isn't there one for each layer?

19 A. There is one for each starting material, so...

20 Q. Can you not answer my question?

21 Is there one for each layer?

22 A. To the best of my knowledge, I would say those two would

23 probably equate.

24 Q. Now, had you ever seen a co-extrusion before you were

25 retained by Cordis in this case?

669

1 A. I have seen extrusion processes. I don't know that I have

2 seen a co-extrusion in particular.

3 Q. Now, you do know Dr. Cohen, who has testified for Boston

4 Scientific in this case, correct?

5 A. Yes, I do know Dr. Cohen.

6 Q. He is a very well-respected polymer chemist and scientist,

7 correct?


9 Q. He does have co-extrusion experience, correct?

10 A. I would believe that he would.

11 Q. Now, you did your graduate -- sorry, you did your college

12 and graduate work in New England, correct?


14 Q. Are you familiar with the polymer chemistry or plastics

15 engineering program at the University of Massachusetts at

16 Lowell?

17 A. Yes, I am.

18 Q. It's one of the best programs in the country, isn't it?

19 A. Yes, it is one of the best programs.

20 Q. And unlike some of the major research institutes like

21 Brown, the University of Massachusetts at Lowell has a plastics

22 engineering program that focuses on the actual manufacturing of

23 real devices for the real world, correct?

24 A. I only know that they are known for their polymer

25 engineering program. I don't know their specifics.

670

1 Q. Would you say that they're nationally known?

2 A. I would say they are nationally known for their polymer

3 program, yes.

4 Q. And isn't it true that Christine Byam was a graduate of

5 that program right before she began her work at Boston

6 Scientific?

7 A. I can't say.

8 Q. You don't know one way or another?

9 A. I do not.

10 Q. Now, let me ask you just a couple more questions about

11 co-extrusion.

12 You consider the use of co-extrusion in medical

13 devices to be a significant scientific achievement, do you not?

14 A. I think in my deposition I said that, generally speaking,

15 co-extrusion was a good contribution to the medical device

16 industry.

17 Q. Didn't you say that a co-extruded catheter tube was a

18 major contribution to the field?

19 A. I think my words were that it was generally a good

20 contribution.

21 Q. Could we have -- your deposition is in the notebook?

22 A. Okay.

23 Q. I'm going to go to page 57, line 19. And I'm also going

24 to put it on the screen, once you get to the page.

25 A. Okay.

671

1 Q. Okay. You tell me which -- you can read it either off the

2 screen or out of the hard copy, whichever is easiest for you.

3 A. Okay.

4 Q. Dr. Pruitt, if you would look at page 57, line 19:

5 "QUESTION: Would you consider the use of

6 co-extrusion in medical devices a significant

7 scientific achievement?

8 "Again, just a general answer, I think the

9 co-extrusion provides unique properties that

10 are needed for this catheter. So as I

11 described earlier, you need to have

12 trackability to pass tortuous vasculature,

13 but you also need to have lubricity, you need

14 compatibility with the balloon. So I think

15 to have a co-extruded catheter tube is a

16 major contribution to this field."

17 Have I read that correctly?

18 A. Yes.

19 Q. Now, you know that Cordis has an expert in this case

20 called Dr. Christian?

21 A. I do not know that.

22 Q. Do you know that they have an expert who has been asked to

23 evaluate the question of whether the Kastenhofer patents are

24 obvious?

25 A. I'm not aware of the other aspects of the case.

672

1 Q. All right. Well, based upon your own experience, you

2 would be qualified, would you not, to look at the Kastenhofer

3 patents, to look at the prior art, and to offer an opinion as

4 to whether they were obvious or not, wouldn't you?

5 A. If I had sufficient time to study those documents, yes.

6 Q. Cordis did not ask you to, correct?


8 Q. And isn't it true that one of the reasons they did not ask

9 you to is because it's your opinion that in general terms a

10 co-extruded catheter tube is a significant scientific

11 achievement?

12 A. I do not know the reasons.

13 Q. Okay. Now, who was the first person to use co-extrusion

14 to make an inner tube of a balloon catheter?

15 A. I don't know that I can answer that question.

16 Q. So you don't know if it was Christine Byam or someone at

17 Cordis, or somebody else?

18 A. Again, I was asked to assess whether the products

19 infringed a specific claim in this patent.

20 Q. Okay. But you could have evaluated the question of who

21 first made a co-extruded catheter tube with a multi-layer

22 design, if you had been asked to, correct?

23 A. If I had studied the appropriate literature, I could have

24 expressed an opinion.

25 Q. Right. But Cordis picked yet another person to talk about

673

1 that, correct?

2 A. Again, I don't know the other aspects of the case.

3 Q. Now, I want to move to a different topic now.

4 Have you read the Kastenhofer patents?

5 A. It's been several years, but, yes, I have read the

6 Kastenhofer patents.

7 Q. And you have read the Fontirroche patents, correct?

8 A. That is correct. I have read the Fontirroche patents.

9 Q. And have you compared the claims of the Fontirroche

10 patents with the claims of the Kastenhofer patents?

11 A. Not in any recent time, I have not.

12 Q. Let me ask it to you this way then. You have some patents

13 of your own, as you told us, correct?


15 Q. Sometimes, you know from your own experience, there can be

16 many patents in a particular field, correct?


18 Q. For example, you mentioned to the jury on Friday that you

19 have a few patents of your own. One of them is a patent

20 entitled, "Plasma-assisted surface modification of polymers for

21 medical device applications," correct?


23 Q. Now, you weren't the first person to use plasma-assisted

24 surface modification, were you?

25 A. No, I was not.

674

1 Q. You weren't the first person to use it to modify the

2 surface of a medical device, correct?


4 Q. What you've -- had done, which is true of many patents, is

5 you had taken what had been done before and you had improved on

6 it, correct?

7 A. Yes, I had made some specific changes that were

8 improvements to the field.

9 Q. Right. So you understand the concept of an improvement

10 patent, correct?

11 A. Again, I'm not a patent lawyer --

12 Q. Sure.

13 A. -- but...

14 Q. I'm asking not as a patent lawyer, but as a scientist, who

15 as you told the jury on Thursday has some patents of her own,

16 okay, are you familiar with the concept of an improvement

17 patent?

18 A. Actually, I'm really not.

19 Q. Would you characterize your own patents as improvements or

20 advances on work that had been done by others before you?

21 A. I guess, to the best of my knowledge, I would say that it

22 had to be an improvement of some sort in order to be issued a

23 patent.

24 Q. Sure.

25 A. So it had to have some uniqueness.

675

1 Q. So, for example, if someone invented the windshield

2 wiper -- do you have that in mind?

3 A. Yes.

4 Q. If the next person invented the intermittent windshield

5 wiper, the second invention would be an improvement on the

6 first, correct?

7 A. Again, I'm not a lawyer, but that seems like it would be

8 an improvement.

9 Q. But the second person who invented the intermittent

10 windshield wiper would still need permission from the first

11 inventor of the windshield wiper before he could make his

12 intermittent windshield wiper, correct?

13 A. Again, I think it goes back to whether the products are

14 covered by the claims of the original patent.

15 Q. And that's why I wanted to ask you about the Kastenhofer

16 and Fontirroche patents. You told us the Fontirroche patent

17 requires a chemical bond, correct?


19 Q. As the Court's interpreted the Kastenhofer patents, there

20 is no requirement of a chemical bond, correct?

21 A. I don't really recall the specific claims of the

22 Kastenhofer patent.

23 Q. Is it true that the Fontirroche patent and its chemical

24 bonded co-extruded catheter is simply an improvement upon the

25 Kastenhofer invention?

676

1 A. I can't say. I've really not studied the Kastenhofer

2 patent.

3 Q. You can't help us with that one way or another, correct?

4 A. I can't answer that question now.

5 Q. But you have studied Claim 7 of the Fontirroche patent in

6 detail, have you not?

7 A. Yes, I have.

8 Q. When is the first time you ever heard of the Fontirroche

9 patent?

10 A. Probably the first time I became aware of Fontirroche

11 patent was when I became involved with this case.

12 Q. So the manner in which you became involved is a lawyer

13 called you?

14 A. Yes. I was asked to be an expert on materials for this

15 case.

16 Q. All right. And the lawyer brought to your attention the

17 Fontirroche patent, correct?


19 Q. And prior to that point in time, you had never heard of

20 the Fontirroche patent, correct?

21 A. There would really be no reason for me to have come across

22 his patent in my day-to-day work.

23 Q. The answer is that you had not heard of it before?

24 A. Had not, that is correct, yes.

25 Q. I'm going to put up on a hard board, if I could, Claim 7,

677

1 because this is the focus of the testimony you gave the jury.

2 And I want to ask you questions about Claim 7, if that's okay.

3 A. That's fine. Thank you.

4 MR. LEE: Your Honor, I'm going to put it there so

5 everybody can see it. And I promised the reporter that if I

6 move to it, I'll face her, if that's okay.

7 THE COURT: Okay.

8 BY MR. LEE:

9 Q. Now, Claim 7, which is on the hard board, is a claim that

10 you talked to the jury about on Thursday, correct?


12 Q. And this is the claim that you say is infringed by Boston

13 Scientific's products, correct?


15 Q. Now, to infringe literally, Boston Scientific's products

16 must meet each and every element of the claim, correct?

17 A. That is my understanding, yes.

18 Q. All right. You can't leave one out, correct?

19 A. That is my understanding for literal infringement, yes.

20 Q. If one of them is missing, there is no literal

21 infringement, correct?

22 A. Again, that was my understanding, yes.

23 Q. Okay. And that's the understanding that you brought to

24 bear on your opinion, correct?

25 A. Yes.

678

1 Q. Now, I want to go through the claim a little bit more -- I

2 want to go through the claim a little bit more slowly and focus

3 on the first paragraph. Do you see that?

4 A. This is really an eye exam. Yes.

5 Q. Let me do this. I'll put it on the screen. And it's also

6 in your notebook at DX-1. And you should use it wherever you

7 can see it the best.

8 Do you have it?

9 A. I do.

10 Q. Now, I want to look at the first paragraph, "A first

11 flexible plastic tube defining a guidewire lumen."

12 Do you see that?

13 A. Yes.

14 Q. "Said first tube being co-extruded of an outer plastic

15 layer and an inner plastic layer."

16 Do you see that?

17 A. I do.

18 Q. So we've got an outer plastic layer and an inner plastic

19 layer. Okay. Correct?

20 A. Correct.

21 Q. Then it says "the plastic materials of said outer and

22 inner plastic layers being different..."

23 That's a requirement, correct?


25 Q. And then it says "bonded to each other."

679

1 Correct?

2 A. Correct.

3 Q. Now, it doesn't just say "bonded." It says "bonded to

4 each other," correct?

5 A. That's what it says, yes.

6 Q. And the "each other" are the outer plastic layer and the

7 inner plastic layer, correct?

8 A. Yes, that's what those words imply, yes.

9 Q. So for this claim to be infringed, the outer plastic layer

10 and inner plastic layer must be bonded to each other, correct?

11 A. That is correct, yes.

12 Q. Now, the Court has interpreted the term "bonded" as it's

13 used in this patent, correct?


15 Q. And I'm going to put on the screen the Court's

16 interpretation of what the word "bonded" means.


18 This is PDX-A061. And the Court has determined that,

19 quote:

20 "Based on the focus of the specification and the

21 substantial evidence concerning how one skilled in the art

22 would read the '594 patent, the Court finds that 'bonded' in

23 Claim 7 of the '594 patent should be construed as chemically

24 bonded."

25 Correct?

680


2 Q. All right. So in order for there to be literal

3 infringement -- so the jury is clear -- there has to be an

4 outer layer, an inner layer, and they must be chemically bonded

5 to each other, correct?


7 Q. And you understand that the words "to each other" are

8 important, correct?

9 A. I understand "bonded to each other" is important, correct.

10 Q. "Bonded to each other" is different than just "bonded,"

11 correct?

12 A. It means that the layers have to be bonded to each other.

13 Q. My question, Dr. Pruitt, isn't it true that the term

14 "bonded to each other" is more specific than just the term

15 "bonded"?

16 A. It's more specific.

17 Q. Right. It -- what this claim does is identifies what

18 needs to be bonded to what, correct?

19 A. The inner and outer layer must be bonded.

20 Q. Right.

21 Now, let's see, you did examine the file history,

22 correct?

23 A. Yes.

24 Q. And the file history is a series of communications that go

25 back and forth between the Patent Office and the applicants,

681

1 correct?

2 A. Yes.

3 Q. And that's a process where the applicant talks to the

4 Patent Office, the Patent Office talks back. But the public

5 doesn't have any right to participate, correct?

6 A. Again, that's not my specific knowledge, but I would

7 assume that that would be the case.

8 Q. Well, based upon the prosecution of your own patents, do

9 you know?

10 A. I wasn't aware whether the public had access to that or

11 not.

12 Q. Okay. Well, let me -- in your notebook is DX-6, which is

13 the file history of the patent.

14 MR. LEE: And we would offer DX-6 at this time, Your

15 Honor.

16 MR. BAUMGARTNER: No objection, Your Honor.


18 (Defendant's Exhibit DX-6 received in evidence)

19 BY MR. LEE:

20 Q. Do you have DX-6 before you?

21 A. I do.

22 Q. Now, this patent application was filed, as we said, on

23 January 31, 1994, correct?

24 A. Yes.

25 Q. And you've reviewed this in detail?

682

1 A. Uhm, it's been quite some time since I've looked at any of

2 the prosecution history, so not in recent time.

3 Q. But you understand that the prosecution history contains

4 statements made by Mr. Fontirroche, Mr. Querns, their lawyers,

5 about what the patent means and what it doesn't mean, correct?

6 A. It would be my understanding that this would be a specific

7 technical correspondence between the Patent Office and the

8 inventors.

9 Q. Right. Now, the applicants are Carlos Fontirroche,

10 correct?

11 A. Yes, I would understand that.

12 Q. What was his contribution to the Fontirroche patent?

13 MR. BAUMGARTNER: Your Honor, objection. This goes

14 beyond the scope of the direct.

15 THE COURT: Overruled.

16 You may answer.

17 THE WITNESS: I don't know his individual

18 contribution, specifically.

19 BY MR. LEE:

20 Q. Well, what was Mr. Querns' contribution?

21 A. Again, I don't know the specific contribution of the

22 individual inventors.

23 Q. And what was Mr. Trotta's contribution? Same answer?

24 A. Yes.

25 Q. Okay. Now, let's talk then a little bit about the written

683

1 record of the communications between the Patent Office and the

2 inventors. Which you did review, correct?

3 A. Again, it's been several years since I've looked at any --

4 any of these correspondences.

5 Q. Well, but you did review them before forming your opinion,

6 correct?

7 A. Yes.

8 Q. All right. Turn, if you would, in DX-6 to the page that

9 has at the bottom "9007." Tell me which you've had a chance to

10 get there.

11 A. Is that 19007?

12 Q. 19007.

13 A. Yes.

14 Q. Actually, why don't we start at 19004, first. Do you have

15 it?

16 A. I do.

17 Q. Okay. Now, this is a portion of the file history,

18 correct?

19 A. It appears to be, yes.

20 Q. These are statements made by Mr. Fontirroche and his

21 lawyers to the Patent Office, in order to get their patent,

22 correct?

23 A. It appears to be that document, yes.

24 Q. Now, let's look at the bottom of page 19004 of DX-6.

25 Quote: A two-page brochure of unknown date from Schneider

684

1 discloses a catheter with a double layer core tube of nylon and

2 HDPE layers."

3 Do you see that?

4 A. Yes.

5 Q. Next sentence: "There is no teaching of a chemical bond."

6 Do you see that?

7 A. I do see that, yes.

8 Q. You do recall reading this, correct?

9 A. Again, it's been years. I don't recall the specific

10 details.

11 Q. Well, Dr. Pruitt, this is what the patent -- this is what

12 the applicant said to the Patent Office in order to get this

13 patent.

14 You understand that?

15 A. I do understand that, yes.

16 Q. That's important, isn't it?

17 A. I would assume so, yes.

18 Q. If they told the Patent Office that something was true

19 were not true, that would be important, wouldn't it?

20 A. Again, I'm -- I'm not the inventor here but, yes, I would

21 assume that would be true.

22 Q. Sure. Now, let's see what they were referring to when

23 they told the Patent Office that they had something that was

24 different because it had a chemical bond. Would you turn to

25 page 19007.

685

1 MR. LEE: If we could have that on the screen.

2 BY MR. LEE:

3 Q. They were talking about the Asuka catheter, correct?

4 A. It appears to be the Asuka catheter, yes.

5 Q. And you were here in the courtroom when we talked to

6 Mr. Liang about the Asuka catheter?

7 A. Yes, I recall the mention of the Asuka catheter.

8 Q. And that was made by Schneider in Europe, correct?

9 A. I don't know the specifics, but that's what I recollect

10 from that conversation you had with Mr. Liang, yes.

11 Q. So the Asuka catheter was a catheter on the market in

12 Europe that had a co-extruded two-layer design. And Cordis, at

13 least, said it does not have a chemical bond, correct?

14 A. Based on this language here, that's what it states.

15 Q. Now, what it says on page 19004 is that the co-extruded

16 catheter is made out of nylon and HDPE. Do you see that?

17 A. Yes, I do.

18 Q. Now, I want you to have in mind that the testimony you

19 gave to the jury about physical bonds or entanglements that are

20 the equivalent of chemical bonds.


22 A. I do.

23 Q. For a catheter like the Asuka, that was on the marketplace

24 and sold tens of thousands as the evidence has established,

25 what kind of bond was there between the nylon and HDPE layers?

686

1 A. In this particular case, there would be no chemical bond,

2 nor would there be an expected entanglement.

3 Q. So there would just be no bond at all?

4 A. I would guess that friction would hold these together.

5 Q. So the friction would be the bond that would hold them

6 together, correct?

7 A. Based on my understanding of chemical bonds, that would be

8 what I would state.

9 Q. And in your view, is that equivalent to a chemical bond?

10 A. It's not a chemical bond. I mean, it --

11 Q. That wasn't my question. I was asking you about your

12 equivalents opinion. Do you remember that little chart you put

13 out?

14 A. I do remember that chart.

15 Q. Isn't it true that as you used -- and you can take a look

16 at it if you would like -- the standards you used to define

17 whether something was equivalent or not -- do you have that in

18 front of you?

19 A. I do.

20 Q. Dr. Pruitt, I want you to have in mind that we're talking

21 about a catheter with a co-extruded tube, correct?

22 A. Correct.

23 Q. That was on the marketplace, correct?

24 A. Correct.

25 Q. That sold tens of thousands, correct?

687

1 A. I don't know.

2 Q. Okay. That had nylon and HDPE, correct?

3 A. Based on this correspondence, yes.

4 Q. And my question to you is, by the standard you applied to

5 determine whether something is equivalent, isn't it true that

6 that friction bond, or whatever it is holding those two layers

7 together, is equivalent, correct?

8 A. Based on my equivalence arguments, we would have a

9 guidewire that doesn't delaminate. But I also understood that

10 that particular combination of materials was susceptible to

11 delamination failures.

12 Q. Dr. Pruitt, can you give this jury a single example

13 anywhere in the world of an Asuka catheter delaminating?

14 A. I haven't studied the Asuka catheter, so I cannot answer

15 that, no.

16 Q. Right. So let's go back to my question. We have a

17 catheter on the market, nylon and HDPE, okay?

18 A. Yes.

19 Q. On the marketplace in Europe, selling. Now, we know it

20 doesn't have a chemical bond because Cordis says it doesn't

21 have a chemical bond, correct?

22 A. That's what it states, yes.

23 Q. Now, my question is this: Isn't it true that judged by

24 the standards you applied to determine whether something is

25 equivalent, that friction bond or that friction securement

688

1 would be the equivalent of a chemical bond, correct?

2 A. It satisfies the function way result analysis.

3 Q. The function way result analysis that you've applied,

4 correct?

5 A. Yes.

6 Q. So that if we explore your opinion in detail, the function

7 way result analysis you would apply would end up covering a

8 catheter that the patent owners explicitly told the Patent

9 Office was different from theirs, correct?

10 A. Again, I can't say to the specific details. Just that the

11 equivalence appeared to be satisfied.

12 Q. All right. Let's see what else the patent applicant said

13 to the Patent Office.

14 Would you turn to page 18989. And I'll put it on the

15 screen, as well, if that's easier to read. Do you have that

16 before you?

17 A. I do.


19 Q. Now, at page 1989 (sic) the Patent Office mentions a

20 patent called Hamlin, correct? Hamlin, H-a-m-l-i-n. Do you

21 see that?

22 THE COURT: Which page are you on?

23 MR. LEE: I'm sorry, 18989, bottom right-hand corner,

24 Your Honor. It's the second page of a rejection by the Patent

25 Office.

689

1 THE COURT: Thank you.

2 MR. LEE: I may have misspoke.

3 THE COURT: Came out several different ways.

4 MR. LEE: Which means I misspoke for sure.

5 BY MR. LEE:

6 Q. I'm sorry, are you at the right page, Dr. Pruitt?

7 A. I'm at the right page, yes.

8 Q. 18989. Now you understand the way things work at the

9 Patent Office, there is an application, there can be

10 rejections, there can be responses, might be other rejections.

11 And if the patent at the end of the day issues, all the

12 objections are overcome, correct?

13 A. That's my understanding, to the best of my knowledge.

14 Q. Right. So what we have on page 18989, is Patent Office

15 saying that some of the claims in the application are rejected

16 as clearly -- as being clearly anticipated by the Hamlin '488.

17 Do you see that?

18 A. I do see that.

19 Q. Now, did you go to the file history and review the Hamlin

20 patent?

21 A. I don't recollect whether I have seen the Hamlin patent or

22 not.

23 Q. If you turn to page 18950, you'll find that the Hamlin

24 patent was in the official record of the Patent Office.

25 Do you have that page?

690

1 A. I'm almost there.

2 Q. Okay. Tell me when you get there.

3 A. I'm there.

4 Q. Do you have it?

5 Now, do you see that the Hamlin patent application?

6 A. I do.

7 Q. This is the application that the patent examiner was

8 discussing with the Cordis folks, correct?

9 A. Yes, the European patent application '488.

10 Q. Let's see who owns this European patent application. It

11 was owned by Schneider, correct?

12 A. Yes.

13 Q. And it described something calls a parison, correct?

14 A. I'm not sure.

15 Q. Do you know what a parison is?

16 A. I'm not sure of the context of your question.

17 Q. Okay. Well, let me do it this way. If you look at the

18 patent itself, the Hamlin patent, and turn to Column 2, Line

19 32.

20 Do you have that before you?

21 A. I do.


23 Q. And do you see the portion which I've put on the screen,

24 that says -- this is the same document you have in the file

25 history from the Patent Office, correct?

691


2 Q. "By forming a three-layer tubular parison, where one of

3 the layers is a plastic with known rupture characteristics, the

4 polyethylene layer may provide the bondability attribute, the

5 PET, the limited radial expansion characteristic, and/or the

6 controlled rupture characteristic while the polycaprolactam

7 again affords the lubricity."

8 Do you see that?

9 A. I see that passage, yes.

10 Q. Now, a parison is a balloon, correct?

11 A. To the best of my knowledge.

12 Q. So what's being described here is a three-layer balloon,

13 correct?

14 A. It appears to be, yes.

15 Q. All right. And it has a polyethylene layer, correct?

16 A. It's stated here as a polyethylene layer.

17 Q. It has a PET layer, correct?

18 A. It states that, yes.

19 Q. And it has something -- and if I mispronounce it, tell

20 me -- called a polycaprolactam layer, correct?

21 A. Yes.

22 Q. And that layer is supposed to provide lubricity, correct?

23 A. That's what it states, yes.

24 Q. Just like the HDPE -- just like the HDPE layer of the

25 Maverick is supposed to provide lubricity, correct?

692

1 A. Yes.

2 Q. So we have three layers, one of which is supposed to

3 provide lubricity, correct?

4 A. It appears to be from this text.

5 Q. Right. Just like the Maverick has three layers, one of

6 which is to provide lubricity, correct?

7 A. The inner layer of the Maverick provides lubricity to the

8 guidewire lumen, the guidewire, yes.

9 Q. Just like the polycaprolactam layer of this piece of prior

10 art, this Schneider patent, does, correct?

11 A. Again, it appears to be, from this text.

12 Q. Sure. Now, after the rejection, the Cordis folks wrote

13 back to the Patent Office, didn't they?

14 A. I don't know specifically, but I would assume, yes.

15 Q. And if you turn to page 19001 to '02, do you have that

16 before you?

17 A. Almost there.

18 Q. Okay. Tell me when you get there.

19 A. I'm at 19002.

20 Q. And why don't we start at 19001, so you can pick up the

21 first sentence that begins, quote, It should be noted that the

22 Hamlin European..." and it goes on to the next page.

23 A. Okay.

24 Q. Now, Cordis said two things to the Patent Office. It

25 said, first, this is about parisons or balloons, not catheters,

693

1 correct?


3 Q. But then it said, second, there's another important

4 distinction. Do you see the portion that says, "Furthermore"?

5 A. Yes.

6 Q. "Furthermore, the multiple layers of the balloon of the

7 Hamlin European publication do not appear to be chemically

8 bonded together. For example, a tube comprising layers of PET,

9 polyethylene, are taught at Column 2 of the publication."


11 A. It appears to be correct.

12 Q. Now, I want to focus on the last sentence, which concerns

13 the third layer and the layer that provides lubricity, okay?

14 Are you with me?

15 A. Yes. I'm just reading this passage.

16 Q. Sure. "Similarly a third polycaprolactam layer is taught,

17 but that also does not seem to be chemically bonded to the

18 other layers."

19 Do you see that?

20 A. I see these words, yes.

21 Q. So Cordis, when it filed its patent application, told the

22 Patent Office that if you have three layers, and the third

23 layer is not chemically bonded to the other two, it's different

24 from their invention, didn't they?

25 A. I feel as though I need more time to study the whole

694

1 context of the patent, to answer that question. But those are

2 the words that you're reading to me, yes.

3 Q. Right. Well, when you studied this file history to

4 prepare your opinions for the case, did you study the Hamlin

5 patent?

6 A. I have not looked -- I have not looked at this document in

7 years.

8 Q. Right. But you will agree with me that it's part of

9 what's before the Patent Office, correct?

10 A. I will agree with you there.

11 Q. You will agree with me it describes a three-layer

12 structure?

13 A. It appears, to be.

14 Q. You will agree with me that Cordis distinguished it on the

15 basis, number one, that it's a balloon, not a catheter,

16 correct?

17 A. Yes, based on the correspondence.

18 Q. And you will agree with me that they distinguished the

19 third layer as not chemically bonded to the other two, correct?

20 A. Based on the words that are here, that seems to be the

21 interpretation.

22 Q. I'm going to put that on the hard board now, your chart

23 DX-3014.


25 A. Yes.

695

1 Q. And one thing you told us is, there was an HDPE layer,

2 correct?

3 A. That's right. There's an HDPE inner layer.

4 Q. Right. And it's not chemically bonded to the next layer

5 or the next layer, correct?

6 A. That is correct. It's not chemically bonded to the

7 Plexar.

8 Q. So it would appear that your analysis of what causes the

9 Maverick to infringe contradicts what Cordis told the Patent

10 Office about what its patent covers, correct?

11 A. I can't say to that opinion.

12 Q. Well, let's just do it this way then. You would agree

13 with me that the Maverick product has a third layer, correct?

14 A. I'm sorry, the Maverick has three layers.

15 Q. Right. And there's a layer that's intended to provide

16 lubricity, correct?

17 A. It appears that that's the use, yes.

18 Q. Yeah. And that third layer, intended to provide

19 lubricity, quote, is not chemically bonded to the other layers,

20 correct?

21 A. Again, I focused on Claim 7, and whether the products

22 infringed on Claim 7. So that wasn't -- I wasn't using this as

23 my specific argument for my case.

24 Q. I understand that. But my question to you, Dr. Pruitt, is

25 this:

696

1 The argument that you made to support your case is

2 inconsistent with what Cordis told the Patent Office, isn't it?

3 A. Again, I can't -- can't agree because I haven't had enough

4 time to really evaluate the Hamlin patent.

5 Q. Well, let's look at what the Patent Office said when --

6 let's go, on the same page, a little further down, to see what

7 else it said, what else Cordis said. Same page, 19002.

8 Do you see the paragraph that begins, "Accordingly"?

9 A. Yes.

10 Q. "Accordingly, it is submitted that the teachings of the

11 claims are not found in the European publication. Specifically

12 in this invention, the chemical bonding between the layers as

13 affected particularly by an inner plastic layer comprising" --

14 is it "vinylic"?

15 (Reporter interrupts.)

16 Q. V-i-n-y-l-i-c.

17 A. Vinylic.

18 Q. "... vinylic polymer having functional groups for such

19 chemical bonding to the other materials."

20 That's what they said, correct?

21 A. Yes, it appears so.

22 Q. And, in fact, they're saying that, the paragraphs I just

23 read to you about what they said to the Patent Office, are

24 actually what lead the Patent Office to issue this patent;

25 isn't that true?

697

1 A. Again, I -- I can't answer that specifically.

2 Q. Well, Dr. Pruitt, the patent examiner wrote a note that

3 said why the examiner thought the patent should issue. Did you

4 know that?

5 A. I'm sure that he did.

6 Q. Yeah. Turn to page 19050 to 19051.

7 Do you have that before you?

8 A. I do.

9 Q. And do you recognize this is what the Patent Office said

10 when it issued the patent? It said, Here are our reasons for

11 issuing the patent, correct?

12 A. I'm sorry, are you referring to a specific passage?

13 Q. Yes, 19050.

14 A. Yes.

15 Q. Paragraph three at the bottom, that says, "The following

16 is an Examiner's statement of reasons for allowance." Do you

17 see that?

18 A. Yes, I do.

19 Q. So this follows the arguments we've just shown the jury

20 about Hamlin, correct?

21 A. Based on what I've seen thus far, yes.

22 Q. Sure. Chronologically it follows there was a rejection

23 from Hamlin; there was an argument that was different; and the

24 patent examiner says, okay, I'm going to let you have a patent,

25 but here's why, correct?

698

1 A. It appears so, yes.

2 Q. And what the patent examiner says, is this:

3 "The intravascular catheter is found to be allowable

4 because the prior art lacks an inner plastic layer extending

5 most of the length of the catheter comprising a major amount of

6 high-density polyethylene having functional groups chemically

7 bonded to the outer layer of the catheter or a minor amount of

8 unsaturated carboxylic acid or an anhydride thereof chemically

9 bonding the outer and inner layers of the catheter."

10 That's what the examiner said, correct?

11 A. That's what he has said.

12 Q. Right. So isn't it true that the examiner accepted

13 Cordis's argument that this patent was different because you

14 have an inner layer and an outer layer, and they are chemically

15 bonded to each other?

16 A. I think he's saying specifically what's written here,

17 right.

18 Q. And isn't he saying that -- hasn't Cordis said that that's

19 different from three layers, where one of the layers does not

20 have a chemical bond?

21 A. Again, I don't know that I can agree with that specific

22 statement without further time to study these.

23 Q. Because you don't know one way or another?

24 A. I can't answer that at this instant.

25 Q. Now, I have your chart, DX-3014, on the hard board,

699

1 correct?


3 Q. How many layers does the Maverick have? Three?

4 A. So the Maverick has the outer layer, which is the Pebax,

5 the inner layer, the high-density polyethylene, and then it has

6 a tie layer, which is the Plexar.

7 Q. Now, Plexar makes HDPE, correct?

8 A. Plexar is a family of tie polymers.

9 Q. Right. But the Plexar that's used in the Boston

10 Scientific product is not HDPE, correct?

11 A. It's a linear low-density polyethylene.

12 Q. Right. So would you agree with me that, as you testified

13 on Thursday, the Maverick has three layers? An inner layer of

14 HDPE, correct?

15 A. Correct.

16 Q. It has a middle layer of LDPE, correct?

17 A. Right. It has a tie layer.

18 Q. And it has an outer layer of Pebax, correct?

19 A. Correct.

20 Q. Now, Dr. Pruitt, you gave your deposition in this case not

21 too long ago, correct?


23 Q. And it was on -- let me get the right date.

24 It was in September of this year, correct?


700

1 Q. Now, at that point in time, you were asked, How many

2 layers does the Boston Scientific product have?


4 A. Yes, I remember that question.

5 Q. And at that point in time, you were focused on the

6 requirement that there be an inner layer and an outer layer,

7 and that they be chemically bonded to each other, correct?

8 A. That's my recollection, yes.

9 Q. Okay. And at that point in time when you were asked in

10 your deposition how many layers does Boston Scientific's

11 products have, you said:

12 "There really are two. There is an HDPE

13 layer and a Plexar layer, but they are really

14 one layer, and they are chemically bonded to

15 the Pebax layer."

16 That's what you said, correct?

17 A. Yes. But in that deposition, I was also addressing two

18 different claims for two different patents. So I just want to

19 make sure I'm clear about the passage you're referring to.

20 Q. Let me show you the passage. It's at page 96. Do you

21 have that before you?

22 A. I do.

23 Q. Now, I want you to have in mind the requirements of the

24 claim, outer layer/inner layer bonded to each other, correct?

25 A. Correct.

701

1 Q. Outer layer/inner layer chemically bonded to each other,

2 as the Court has interpreted, correct?

3 A. Correct.

4 Q. So what you said in your deposition was:

5 "Well, here's how I find an inner layer and

6 outer layer chemically bonded to each other.

7 The inner layer would be these two things.

8 The outer layer would be this red thing. And

9 they are chemically bonded to each other."

10 That's what you said, correct?

11 A. I said two things. I said one way to look at this was

12 that we had an inner layer and an outer layer that were bonded

13 via the Plexar. So like a brick-and-mortar model. And I said

14 it was a glass half full/glass half empty type analogy.

15 The other way to interpret it would be that we had

16 entanglement between the, as you've said, the inner

17 high-density polyethylene and the middle Plexar layer, and that

18 that would be essentially a very density polyethylene that

19 would be the inner layer bonded to the outer layer. So, yes.

20 Q. Let's take that in parts. Let me take your brick and

21 mortar example, which you used last week.

22 A chemical bond requires the entanglement of

23 electrons, or the sharing of electrons, correct?

24 A. It requires the sharing of electrons.

25 Q. Right. And in your brick and mortar example the two

702

1 bricks don't share one single electron, do they?

2 A. Again, it was a demonstrative. It was to make the case

3 that two things could be bonded without touching.

4 Q. Right. But we're talking about a chemical bond, not just

5 any bond.

6 You understand Her Honor has already decided this?

7 A. Yes, I do.

8 Q. So I want to figure out just how good your brick and

9 mortar example is. The Court said it needs to be a chemical

10 bond, correct?


12 Q. As a scientist, you know for there to be a chemical bond

13 the two materials need to share electrons, correct?

14 A. Either need to share or transfer electrons, correct.

15 Q. That's different than this physical entanglement that you

16 talked about, correct?

17 A. Yes. While they are equivalent in their structural

18 performance, they are different, yes.

19 Q. And in the -- I'm sorry. Are you finished?

20 A. Yes, I am.

21 Q. If I do that, just tell me, okay. She'll get very mad at

22 us. The reporter will get mad at us if we don't.

23 In your brick and mortar example, the two bricks are

24 not sharing any electrons, are they?

25 A. I don't really know the specific nature of how the bricks

703

1 are -- the chemistry involved.

2 Q. Well, the brick and mortar example that you gave the jury

3 does not satisfy the Court's definition of an inner layer and

4 an outer layer chemically bonded to each other, correct?

5 A. I can't say what the chemistry is. I was really using it

6 as a demonstrative, to show that two things could be bonded to

7 each other without physically touching.

8 Q. Can they be chemically bonded to each other without

9 physically touching?

10 A. If the middle layer provides that mechanism.

11 Q. So is it your testimony, Dr. Pruitt, that two bricks with

12 mortar in between are chemically bonded?

13 A. I can't -- I can't say what the chemistries of the mortar

14 to the brick is.

15 Q. Let's see what you said at your deposition, about the

16 question of how many layers there were. And if you would turn

17 to page 97, and the question at 22:

18 "So I guess I just want to be clear as to

19 what your theory is. It's that you're

20 treating the mechanically -- what you say is

21 mechanically entangled Plexar layer and the

22 HDPE layer as a single layer?"

23 Answer on page 97:

24 "I'm saying that one way to look at that,

25 that structure, is that the Plexar Marlex in

704

1 the entangled mechanism provides a

2 polyethylene layer, yes."

3 That was your testimony, correct?

4 A. Yes. As I said, one way to look at it is that we have

5 entanglement between that inner layer and that Plexar

6 intermediate layer.

7 Q. Which is it? Are there three layers or two layers in the

8 Boston Scientific product?

9 A. Again, I think it's -- it's whether the glass is half full

10 or half empty. I think it's just interpretation.

11 I made two different analogies. So one

12 interpretation is that I -- and that's why I said one way to

13 look at it.

14 One interpretation is that we have high-density

15 polyethylene that is entangled with that middle layer, in which

16 case we could refer to that as one polyethylene layer that's

17 varying in its structure, and that that layer is chemically

18 bonded to the outer layer.

19 Q. Let's take it in pieces, Dr. Pruitt.

20 A. Okay.

21 Q. Let me ask you to assume the first of your two examples,

22 the one you gave the jury last Thursday.

23 A. Okay.

24 Q. There are three layers, dark green, light green, and red.

25 A. Okay.

705

1 Q. It's true, is it not, that the dark green layer is not

2 chemically bonded to the red layer, correct?


4 Q. So if we read the claim literally, it says, An outer

5 plastic layer and an inner plastic layer bonded to each other,

6 the Boston Scientific product does not do that by that

7 interpretation, correct?

8 A. The high-density polyethylene does not directly bond the

9 Pebax. But it is chemically bonded via the Plexar.

10 Q. Now, the claim doesn't say bonded to something else. It

11 says "bonded to each other," doesn't it?

12 A. But it doesn't say where the bond needs to be. It just

13 says that they need to be bonded to each other.

14 Q. Dr. Pruitt, let me take out the words "to each other."

15 Just scribble them out of the claim.

16 A. Okay.

17 Q. The claim has exactly the same meaning to you with those

18 words gone, correct?

19 A. There's a chemical bond, and that's the mechanism by which

20 the inner and outer layers are bonded. It's just in this case

21 it's achieved through a Plexar tie layer.

22 Q. Is the answer to my question correct, those words have no

23 meaning as you've interpreted the claim?

24 A. I wouldn't say they have no meaning. I'm, as I said,

25 giving you my interpretation based on the schematic I have

706

1 below.

2 Q. You understand that the infringement question for this

3 jury is defined by the words in that claim?

4 A. I do.

5 Q. And my question to you -- and I apologize for doing it

6 again, but I would like to get an answer to it -- is, if the

7 words "to each other" are eliminated, if you just white them

8 out, the claim has exactly the same meaning as we've just

9 given, because the inner layer and the outer layer are bonded

10 through the middle layer, correct?

11 A. They are bonded to each other through the middle layer.

12 Q. So the answer is true, correct?

13 A. Uhm, again, I -- they are bonded to each other. But it's

14 via the Plexar tie layer.

15 Q. Well, how is that different from Hamlin?

16 A. Again, I would need time to -- to study that in further

17 detail, to answer that appropriately.

18 Q. How is that different from what Cordis told the Patent

19 Office? Or do you not know?

20 A. I don't think I can answer that specifically at this

21 moment in time.

22 Q. Let's take a look at the patent. And I'm going to put

23 Figure 2 of the patent on the screen.

24 Figure 2 is in the patent, but it's also on the cover

25 of the patent, correct?

707

1 A. Yes, that's correct.

2 Q. And item 20 is the inner tube, correct?

3 A. I believe so, yes.

4 Q. And what this example shows is an outer portion, which is

5 32, correct?

6 A. Yes.

7 Q. An inner portion, which is 34, correct?

8 A. Correct.

9 Q. And they are directly bonded to each other, correct?

10 A. That's what's illustrated in this particular figure, yes.

11 Q. Right. Now, last Thursday you testified that, by your

12 words, there is something called a nonpreferred embodiment in

13 the patent?

14 A. Yes.

15 Q. Is that a word that you learned from counsel?

16 A. It's a word that I've learned in working in the -- in the

17 legal aspects of this case.

18 Q. All right. So let's make sure we understand. A preferred

19 embodiment --

20 MR. LEE: Could I have Figure 2 back on the screen.


22 BY MR. LEE:

23 Q. A preferred embodiment means here is the example of what

24 the inventors preferred as their invention, correct?

25 A. That's my understanding, that it's the preferred

708

1 configuration, yes.

2 Q. So, so the jury knows, the preferred configuration is

3 Figure 2; is it not?

4 A. That's what's given as the example in the patent, yes.

5 Q. And the preferred configuration has two layers chemically

6 bonded directly to each other, correct?

7 A. That's the preferred embodiment that's shown in Figure 2.

8 Q. Now, you said that there was a nonpreferred embodiment

9 that involved a tie layer, didn't you?

10 A. Yes, I did.

11 Q. Let's put up on the screen and now go carefully through

12 the words that you talked about, Column 2, Line 56, to Column

13 3, line 13.

14 Do you have those before you?

15 A. Yes, I do.

16 Q. Now, in this portion of the patent, the inventors actually

17 use the word "tie layer," don't they?

18 A. Yes. Ask if they could bring that up.


20 Q. Right? They actually use the word "tie layer" correct?

21 A. I'm actually just trying to read this document quickly

22 here.

23 Q. Why don't you read it, and tell me when you have had a

24 chance, because I want to go through it a little bit more

25 slowly than we did last week.

709

1 A. Okay.

2 MR. LEE: Okay. And so can I actually get this

3 column and the next column put side by side, so that Dr. Pruitt

4 can see it all together. Just give us a second, and we'll put

5 them side by side, Dr. Pruitt.


7 BY MR. LEE:

8 Q. Now, do you see at the top of Column 3, Line 1, the word

9 "tie layer" is used, correct?



12 Q. Now, you understand what a tie layer is, correct?

13 A. I do.

14 Q. Now, having used the word "tie layer" in the

15 specification, can we agree that the applicants, when they got

16 their claim, had no mention of a tie layer, correct?

17 A. It is not listed specifically in Claim 7, that's correct.

18 Q. Now, let's see if they said they were using a tie layer

19 or, instead, whether someone else had used a tie layer before.

20 Do you see at the top, I'm going to begin at line 60,

21 "Typically, known resins manufactured or sold by the Quantum

22 Chemical Company under the trademark Plexar may be used for the

23 inner plastic layer."

24 You do understand what that means, correct?

25 A. I do, yes.

710

1 Q. "These materials are vinylic, for example, polyethylene of

2 varying densities, polypropylene, or polyethylene vinyl

3 acetate, which are copolymerized with a small amount of maleic

4 acid." Have I read that correctly?

5 A. Yes, you have.

6 Q. Now that's a chemist's way of saying that what you've done

7 is taken these materials and mixed in a small amount of maleic

8 acid, correct?

9 A. Right. We've added functional groups to the polymer.

10 Q. But what you get out of that is a single material that has

11 functional groups in it, correct?

12 A. Yes. We have a copolymer now.

13 Q. Okay. "These materials are vinylic, for example,

14 polyethylene of varying densities." I just read that sentence.

15 Now let's go to the next sentence. "These materials

16 have previously been used as tie layers for multi-layer plastic

17 sheeting, the Plexar material being an inner layer which bonds

18 together dissimilar outer plastic layers."

19 Do you see that?

20 A. I do see that, yes.

21 Q. Now, we went through this very quickly last Thursday, but

22 what the patent says about the tie layer is, the materials

23 we've just described for you have previously been used as tie

24 layers for multi-layer plastic sheeting, correct?

25 A. He was just saying that this material has precedence

711

1 elsewhere.

2 Q. Right. It never says you can use a tie layer for this

3 invention, does it?

4 A. I actually disagree. I think if we read down to the next

5 paragraph, it makes a statement about this polymer used in this

6 application, starting with the words "preferably."

7 Q. Why don't you show -- let's bring it up, and I want you to

8 tell the jury -- I want you to have in mind two things. I want

9 you to have in mind this polyethylene that has mixed-in

10 functional groups, which is just a new material that forms a

11 layer of that new material, in contrast to a separate tie

12 layer. Do you have that in mind?

13 A. No, I'm not sure what you mean by that question, actually.

14 Q. Did you not know there was a difference between a

15 polyethylene that has maleic acid mixed in, which forms a

16 layer --

17 A. Right.

18 Q. -- on the one hand, or two materials, one of which is a

19 tie layer, the other of which is polyethylene? Did you know

20 there was a difference?

21 A. Again, I'm not clear in your question, sir. I'm sorry.

22 Q. Let me see if I can do it this way. Did you know that

23 Mr. Trotta was specifically asked whether there was a

24 difference between the two?

25 A. No, I'm not aware of that.

712

1 Q. Have you reviewed Mr. Trotta's testimony in a prior

2 proceeding in this case?

3 A. Not recently, I have not.

4 MR. LEE: Can I have Mr. Trotta's deposition

5 testimony on the -- I'm sorry, can I have Mr. Trotta's

6 testimony from the prior proceeding on the screen.

7 And it's at proceeding date three, page 1721, line 4.

8 MR. BAUMGARTNER: Objection, Your Honor. If there

9 was no reliance on this and the witness didn't review it, I

10 don't think this is appropriate.

11 MR. LEE: Your Honor --

12 THE COURT: Overruled.

13 You may proceed.

14 MR. LEE: I apologize, Your Honor. It just takes a

15 second to bring it up.


17 BY MR. LEE:

18 Q. There was a prior proceeding in this case. You know that?

19 A. Yes.

20 Q. Mr. Trotta testified. Did you know that?

21 A. I'm aware of it now, yes.

22 Q. And I want to have -- Dr. Pruitt, I want you to have in

23 mind, as best you can, the two different situations I offered

24 to you.

25 One is polyethylene with some maleic acid or

713

1 something else mixed in to form a new functionalized material,

2 but still one material. Okay?

3 A. Okay.

4 Q. As distinct from, for instance, a polyethylene with a

5 separate tie layer like the Maverick. Okay?

6 A. I'm doing the best I can with that analogy, yes.

7 Q. The Maverick doesn't have a Pebax layer with

8 functionalized groups mixed in, does it?

9 A. No. It's Pebax.

10 Q. Right. It has a separate tie layer, correct?

11 A. That is correct. It has the Plexar tie layer.

12 Q. So let's see what Mr. Trotta said about those two

13 situations, and which one is covered by the patent and which

14 one isn't.

15 MR. LEE: Could I begin at Line 721, Line 4. And

16 they're talking about Mr. Querns's notebook.

17 "QUESTION: What was your understanding of

18 what Mr. Querns was talking about here?

19 "ANSWER: Steve wanted to co-extrude a nylon

20 over an HDPE tie layer, and that would

21 provide a chemical bond between HDPE and the

22 nylon."

23 Then the Court, says, Judge Illston:

24 "What is the tie layer in between?

25 "THE WITNESS: No, this would be not in

714

1 between. You would just have -- they sell

2 tie layers that contain -- large majority of

3 it is high-density polyethylene, and then a

4 small amount of adhesive is added. It's

5 actually anhydride modified high-density

6 polyethylene is added to it in a small

7 amount. That allows the HDPE to be bonded

8 directly to the nylon 12 so you would only

9 need two layers."

10 Do you see that?

11 A. I do.

12 Q. And of my two situation, number one and number two, in

13 response to Her Honor's question Mr. Trotta said:

14 "No, it's not a separate layer. It's

15 actually material added to the first layer

16 that allows the chemical bond to the second

17 layer."

18 A. That's what it states here.

19 Q. That's what Mr. Trotta said?

20 A. Right.

21 Q. And you would agree with me that Mr. Trotta, one of the

22 named inventors, would know what this patent is about, correct?

23 A. I would assume he would.

24 Q. So let's go on further. Question by Mr. Baumgartner:

25 "So the HDPE layer is Plexar 209?

715

1 "ANSWER: Yes.

2 Answer:

3 "And the Plexar 209 has this glue in it

4 that, in effect, causes the nylon and Plexar

5 209 to form chemical bonds?"

6 That's actually the question.

7 "ANSWER: Yes.

8 "QUESTION: Now, give us an example of what a

9 chemical bond is.

10 "ANSWER: These are covalent chemical bonds.

11 Covalent chemical bonds -- some covalent

12 chemical bonds would be" --

13 If we go to the next page.

14 "Now, give us -- some covalent chemical

15 bonds would be such as hydrogen to oxygen,

16 water.

17 "QUESTION: How strong is a typical chemical

18 bond?

19 "ANSWER: Very strong.

20 "QUESTION: Was the use of this Plexar 209

21 material to form chemical bonds with nylons,

22 was this a new idea to you at the time you

23 learned about it?"

24 Mr. Trotta says:

25 "Yes, it was.

716

1 "QUESTION: From Mr. Querns?

2 "ANSWER: That was a new idea to me.

3 Question, and this is from Mr. Baumgartner again:

4 "Now, in the concept described here, would

5 it be more accurate to refer to the Plexar

6 209 material as an HDPE with a tying

7 ingredient as distinct from a third layer

8 between the high-density polyethylene layer

9 and the nylon layer?

10 "ANSWER: Yes, that would be fair.

11 "QUESTION: There are other designs" --

12 Have I read it correctly up until then?

13 A. Yes.

14 Q. Next question:

15 "There are other designs that involve a

16 third layer between the nylon and the HDPE;

17 that's really a tie layer in the sense that

18 it's physically distinct?"

19 And Mr. Trotta said:

20 "Yes. The reason they call it a tie layer

21 is in the industry it's more expensive than

22 normal -- than the other material -- the base

23 material like HDPE. So very seldom when you

24 tie -- you use as little as you could of the

25 tie layer because it's expensive. But in the

717

1 industry it's not, so we just bonded it

2 directly together."

3 Do you see that?

4 A. I see that.

5 Q. So Mr. Trotta was asked explicitly about the two

6 situations I just gave you. Situation one, where you mix in

7 the material so there can be a chemical bond, and situation,

8 two where there is a tie layer, correct?

9 A. Correct, that's what he stated, yes.

10 Q. And what Mr. Trotta the inventor says is those catheters,

11 those other designs that involve a third layer, are different,

12 correct?

13 A. Uhm, it's my interpretation that he's making a distinction

14 between whether -- about this -- this tie -- functionalized

15 polyethylene, whether it's different.

16 Q. Dr. Pruitt --

17 A. Yes.

18 Q. Quote, there are other designs that involved a third layer

19 between the nylon and HDPE?

20 A. I see that, yes.

21 Q. Do you see that? Right.

22 "Other designs" means other designs different from

23 what Cordis has done, doesn't it?

24 A. Again, I don't know what the specific design differences

25 are, but that's what the verbiage says, yes.

718

1 Q. Right. And, in fact, if you go back one page in response

2 to Her Honor's question about what is a tie layer, he said, no,

3 we're not using a tie layer; we're doing something different.

4 Isn't that what he said?

5 A. It's also my understanding that it distinguishes itself as

6 a tie layer when you have two different materials on either

7 end. And if you use it in its own right, we can refer to it as

8 a functionalized material.

9 Q. Dr. Pruitt, isn't it true that what Mr. Trotta testified

10 on the stand in a prior proceeding flatly contradicts your

11 opinion in this case?

12 A. I don't -- I don't agree with that, sir. I'm sorry.

13 Q. All right. And no one ever gave you Mr. Trotta's prior

14 testimony before; is that right?

15 A. Not to my knowledge, no.

16 Q. All right. Have you read Mr. Trotta's deposition?

17 A. Uhm, if it's been recent, I have not.

18 Q. No, it's actually been -- it's a couple of years ago.

19 A. Okay. If I read it at all, it would have been several

20 years ago.

21 Q. Have you read Mr. Fontirroche's deposition?

22 A. Again, same answer. It would have been several years ago,

23 if I read it.

24 Q. And do you know if they had anything to say about the

25 question of whether a tie layer is something that they had in

719

1 mind when they filed their patent application with the Patent

2 Office?

3 A. Again, I would need to reread those, to answer your

4 question correctly, sir.

5 Q. Fair enough.

6 MR. LEE: Your Honor, I'm about to move on to a new

7 subject, if you want to take the first morning break.

8 THE COURT: Ladies and gentlemen, we will take a

9 brief recess at this time, for approximately 15 minutes. If

10 you would please not speak to each other or anyone else about

11 this case. Don't make up your minds. You haven't heard all

12 the evidence.

13 Have a great break. We'll see you in about 15

14 minutes.

15 (Jury out at 9:55 a.m.)

16 THE COURT: You can step down.

17 (Whereupon there was a recess in the proceeding's

18 from 9:55 until 10:21 a.m.)

19 THE COURT: Welcome back, ladies and gentlemen. You

20 may be seated.

21 Mr. Lee, you may proceed.

22 BY MR. LEE:

23 Q. Dr. Pruitt, during the recess did you have an opportunity

24 to talk to your lawyers?

25 A. Yes, we spoke briefly.

720

1 Q. And did you talk about some of the questions I had asked

2 you on cross-examination?

3 A. We didn't speak about any questions. I just looked at the

4 patent that you brought up to me again.

5 Q. Now, right at the time we recessed, I asked you about

6 whether you had read Mr. Fontirroche's deposition, correct?


8 Q. I think you told me you couldn't recall?


10 Q. Let me put on the screen page 127 of Mr. Fontirroche's

11 deposition from November 25th, 2002 and ask you if you recall

12 reading these questions -- this question and this answer about

13 tie layers from Mr. Fontirroche.

14 "QUESTION: Do you recall any experiments you

15 did where you had a straight HDPE as the

16 inner layer, a tie layer as an intermediate

17 layer, and nylon 12 as the outer layer?

18 "ANSWER: No, I don't recall."


20 Q. And that question would describe the type of tri-layer

21 structure that Boston Scientific has, correct?

22 A. To the best of my knowledge it would be a similar class.

23 Q. The answer is yes?

24 A. To the best of my knowledge, yes.

25 Q. Now, I want to go to a slightly different topic which is

721

1 this question of a chemical bond versus a physical

2 entanglement.

3 A. Okay.

4 Q. I think you told the jury last Thursday that a physical

5 entanglement is a little bit, by analogy, like Christmas lights

6 getting tangled together?

7 A. That was the analogy I drew, yes.

8 Q. Now, as a scientist, you understand the difference between

9 a chemical bond and a physical entanglement, correct?

10 A. I do, yes.

11 Q. And one of the major differences is that for a chemical

12 bond, as you told me earlier, you share electrons, correct?

13 A. Right. We either share electrons or transfer electrons,

14 yes.

15 Q. But for a physical bond, there is no sharing of electrons,

16 correct?

17 A. That's correct. We rely on entanglement of the chain.

18 Q. Right. But there are other differences between

19 entanglement of the chain and a chemical bond, are there not?

20 A. Yes, there are.

21 Q. For instance, a chemical bond is usually a bond of short

22 range order? It's shorter, correct?

23 A. Yes. The length scale is typically very short.

24 Q. It's typically on the order of a few angstroms?

25 A. That's correct. It's typically on the order of a few

722

1 angstroms.

2 Q. And to help us, how long is a angstrom?

3 A. Ten to the minus tenth meters. So extremely small

4 measure.

5 Q. So they are very, very small --

6 A. Yes.

7 Q. -- right?

8 Now, in contrast, the entanglement chains that you

9 talked about, the length is typically much longer, correct?


11 Q. Now, the entanglement, the physical entanglement is driven

12 by a process called diffusion, correct?

13 A. Yes, that's one of the mechanisms.

14 Q. But the chemical bonds are not driven by a process called

15 diffusion, correct?


17 Q. Now, you can measure or you can quantify on the one hand

18 physical entanglement, correct?

19 A. You can use techniques to try to quantify an entanglement

20 density.

21 Q. And you can also techniques to quantify the degree of

22 chemical bonds, correct?

23 A. Yes. We would use different techniques, but you can

24 actually quantify the presence of a chemical bond, yes.

25 Q. And you would use different techniques because they are

723

1 different types of bonds correct?

2 A. Different types of bonds and different length scales, yes.

3 Q. So, for instance, for the chemical bonds you use something

4 called X-ray defraction, correct?

5 A. You may use X-ray defraction or spectroscopy as a

6 technique.

7 Q. But that wouldn't be usable for the physical entanglement,

8 correct?

9 A. Entanglement would use a different technique, yes.

10 Q. Physical entanglement is time dependent or transitory; it

11 exists for a time, correct?

12 A. That's correct. Given enough time, it could change, yes.

13 Q. Sure. It's as you said with the Christmas lights, over

14 time they can be untangled, correct?

15 A. Yes. And patience, yes.

16 Q. Chemical bonds are permanent, correct?

17 A. Unless those bonds are broken by some mechanism, yes.

18 Q. Now, I want to go back to the claim the jury is going to

19 be asked to consider, and I want to ask you about some more of

20 the requirements of the claim. It's in your notebook as well.

21 It's hard to read from here.

22 We look at the outer layer and inner layer and the

23 requirement they be bond to each other, but there are some more

24 requirements for the inner layer and the outer layer, correct?


724

1 Q. One requirement is:

2 "Said material of the inner plastic layer

3 being more flexible" -- right -- "and

4 exhibiting a more lubricious surface than the

5 material of said outer plastic layer."

6 Correct?


8 Q. So the word that is used in the claim is the "material" of

9 the layer, correct?

10 A. That is the word that's presented in the claim, yes.

11 Q. Now, when you read the file history, did you see what the

12 patentee had said to the Patent Office about the importance of

13 using a flexibility of the material as your measurement?

14 A. I don't recall the specifics of that.

15 Q. Right. Would you agree with me that the phrase, "said

16 material of the inner plastic layer being more flexible" is

17 different in meaning than a phrase that said, "said inner

18 plastic layer being more flexible"?

19 A. Again, I -- I think there's places in the specifications

20 of the patent that interchange the use of "material" and

21 "layer." I agree with you grammatically.

22 Q. Right. And, in fact, grammatically when you gave the jury

23 injury opinion, you compared the flexibility of the inner

24 plastic layer with the outer plastic layer; you didn't compare

25 the materials, correct?

725

1 A. I would like to clarify that. The flexibility is, as I

2 said before, a geometric requirement, so you can't isolate a

3 material alone in assessing that.

4 Q. Is that what Cordis said to the Patent Office?

5 A. I see what's here in the claim. It says "more flexible."

6 Q. My question to you is this: As you interpret the claim,

7 isn't it true that the claim has precisely the same meaning if

8 I eliminate the words "material of the"?

9 A. Again, I'm not a patent attorney, so I'm a little

10 skeptical with what happens when one takes out a word. I can

11 really only speak as a scientist here and say what it means to

12 be more flexible than another material.

13 Q. But you would agree with me that as the claim is written,

14 it's talking about the flexibility of the material in the inner

15 plastic layer, correct?

16 A. Yes. And as I said before, flexibility is not a material

17 property. It's a -- it's an combination of material and

18 geometry.

19 Q. Dr. Pruitt, can't you look up the flexibility of a

20 material?

21 A. No, you cannot. You can look up the flexural modulus of a

22 material, which is different then flexibility.

23 Q. There's something called a flexural modulus?


25 Q. I'm going to come back to that --

726

1 A. Okay.

2 Q. -- because if you look up the flexural modulus and use

3 that as a measurement of flexibility, there is no infringement,

4 right?

5 A. That would require identical geometries and that's not the

6 case for the catheter.

7 Q. That wasn't my question. If you use the flexural modulus

8 as a measurement of the flexibility of the material tube, if

9 you use that, there is no infringement, correct?

10 A. If you use it, it doesn't satisfy the way the patent

11 describes the use of this catheter for design.

12 Q. Well, let's see what they -- let's see what Cordis said to

13 the Patent Office and whether that's consistent with your view.

14 If you go back to Defendant's Exhibit 6, please, and

15 I'm going to take you to page 18986. Do you have that?

16 A. I do.

17 Q. I'm going to take you through a series of steps. The

18 first at 18986, there is an action by the Patent Office and

19 certain of claims are rejected. Do you see that?

20 A. I do.

21 Q. Claims 1 through 6 and 8 through 18 are rejected. Do you

22 see that?

23 A. Yes.

24 Q. If you go to page 18989, do you see at the top, one of the

25 reasons for rejecting the claims that were before the Patent

727

1 Office was that it was anticipated by a patent to a man -- to

2 an inventor named Parker; do you see that?


4 Q. Right. And you understand that what the Patent Office is

5 saying is we reject these claims, whatever they were at the

6 time, because of Parker?

7 A. I see this text, yes.

8 Q. All right. Now, Parker is in the file history, correct?

9 A. I don't recall specifically.

10 Q. All right. Well, then let's see what Cordis said about

11 Parker. Turn, if you would, to page 18993?

12 (Witness complied.)

13 Q. Do you have that before you?

14 A. I do.

15 Q. And I'm putting that on the screen.


17 Q. And it says, "In response to the Office Action of

18 April 12, 1995." You understand this is Cordis responding to

19 what the Patent Office had done, correct?

20 A. Yes. I'm just confirming that, yes.

21 Q. And if you turn now to page 18998?


23 Q. Do you have that before you?

24 A. I do.

25 Q. And you see the portion that says:

728

1 "The examiner has rejected Claims 1 through

2 3, 9, 10 and 13 as anticipated by Parker"?


4 Q. And if you go to o to the next page, it says:

5 "Also, at column 4, lines 22 to 24 of

6 Parker, it is stated that the polyether block

7 amide material is softer than that of the

8 inner layer. To the contrary, Claims 3

9 through 13, et cetera, of this application

10 require the material of the outer plastic

11 layer of this invention to have greater

12 stiffness and not be softer than the material

13 of the inner plastic layer."

14 Do you see that?

15 A. I see the passage, yes.

16 Q. Now, did you review Mr. Fontirroche's deposition to see

17 what he thought they were referring to, whether they -- he

18 thought they were referring to the material?

19 A. As I said earlier, it's been years since I looked at any

20 of the Fontirroche document.

21 Q. Can I have page 156 of Mr. Fontirroche's 2002 deposition,

22 please?


24 Q. This is Mr. Fontirroche testifying about his patent and

25 his invention, and at line 19 it states:

729

1 "QUESTION: Okay. Now, when you say that

2 material in its own right for its desired

3 characteristic?

4 "ANSWER: Right. If you want a stiff

5 material, you put in a stiff material.

6 "QUESTION: Okay.

7 "ANSWER: If you want a flexible material,

8 you put in a flexible material. And if you

9 want a lubricious material, you put in a

10 lubricious material.

11 "QUESTION: Okay. That's fine. Thanks."

12 And if we go back to the previous page, you will see

13 that Mr. Fontirroche was talking about his patent. So the

14 comparison he's making is of the stiffness of the materials,

15 correct?

16 A. Yes, but I -- again, these layers have specific ratios of

17 thickness relative to each other. So the flexibility is a

18 combination of the thickness and the flexural modulus.

19 Q. Let me ask you that: When you described to the jury your

20 text for your computations, you took into account both the

21 flexibility of the material and the structure of the material,

22 correct?


24 Q. But when you measured the inner layer, the flexibility of

25 the inner layer, you only measured this layer, HDPE

730

1 (indicating), correct?

2 A. That's correct. We only took the flexural methods for

3 high density polyethylene and made that calculation on that

4 thickness.

5 Q. You didn't measure it for the combination of these two,

6 correct?

7 A. No, I did not, not in that analysis.

8 Q. So I want to go back. You told us there were two ways to

9 do the Boston Scientific product. One was that the dark green

10 and the light green are really one layer and they are

11 chemically bonded to the other layer, correct?

12 A. That's one way to look at that, yes.

13 Q. But if we take that view of the world, you never measured

14 the flexibility of this combined layer, did you?

15 A. No. I would need flexural modulus of the Plexar to do

16 that analysis.

17 Q. So if we take that view of the world, you haven't done the

18 analysis to say whether the Boston Scientific catheter

19 infringes the patent, correct?

20 A. I have not done that specific analysis, that's correct.

21 Q. So we can set that analysis aside. The analysis that two

22 layers chemically bonded to the third layer we can set aside

23 because we don't know whether it infringes or not, right?

24 A. I can't answer that as I sit here right now, correct.

25 Q. The only way that this could possibly infringe is to treat

731

1 these as three layers, correct?

2 A. I don't know if that's the only way it could infringe.

3 That's the only way I have analysis for it.

4 Q. I'm sorry. Fair enough. The only way the jury can find

5 infringement under your analysis is if we treat them as three

6 separate layers and have the dark green layer, in your view,

7 chemically bonded directly to the red layer, correct?

8 A. I think -- again, I have one analysis that's presented

9 here and one is to look at, specifically for the claim

10 language, that the inner layer be more flexible than the outer

11 layer. So, yes, the way you phrase that, yes.

12 Q. And does the red layer, Pebax, share any electrons with

13 the HDPE layer?

14 A. The red layer does not share any electrons with the inner

15 high density polyethylene layer.

16 Q. So if we take the Court's construction, which requires a

17 chemical bond, and we take your definition of a chemical bond,

18 which requires the sharing of electrons, we can agree that the

19 HDPE layer does not share electrons and have a chemical bond

20 with the red layer, correct?

21 A. The chemical bond is created through Plexar. There is no

22 direct electron transfer.

23 Q. So my statement is correct?

24 A. The way it's stated, yes.

25 Q. Now, let me go to the material property. If I

732

1 mispronounce it, I apologize. We talked a minute ago about

2 flexural modulus, correct?


4 Q. That's a material of the property, correct?

5 A. That's a material property, yes.

6 Q. And how would you describe it as a material property?

7 What kind of material property is it?

8 A. Okay. It's -- it's like the elastic modules. The

9 material actually is tied back to the physical structure of the

10 polymer or, as I demonstrated on Thursday, the aluminum itself.

11 So all three bars of that aluminum have the same flexural

12 modulus, the same resistance to deformation in terms of stress

13 strain space.

14 Q. And for something that has the same geometry, the same

15 structure, is flexural modulus a measure of flexibility?

16 A. If I have identical geometry. So, in other words, if I

17 had my thick bar of aluminum and compared that to a thick bar

18 of identical geometry of rubber, the rubber would be more

19 flexible, yes.

20 Q. So, and this is something that you can just go ahead and

21 look up, correct?

22 A. You can look up the flexural modulus, correct.

23 Q. Now, I have your diagram on the screen. I want to know,

24 did you look up the flexural modulus for HDPE?

25 A. I did.

733

1 Q. What was it?

2 A. It's in my expert report. I would have to get the number

3 for you.

4 Q. Is it approximately 1.654 gigapascals?

5 A. Actually, I could probably just confirm that if I look at

6 my report.

7 Q. Sure, go head.

8 A. Actually, I think it's probably in my deposition even.

9 Q. I think it's in your expert report at page 12, lines 6

10 to 7.

11 A. Yes. I have the flexural modulus of the high density

12 polyethylene is 170ksi. You converted it, yes.

13 Q. What is the flexural modulus of Pebax, the red layer?

14 A. The flexural modulus is 106 ksi.

15 Q. Right. Now, just so the jury knows how to compare, a

16 material with a lower flexural modulus is more flexible than a

17 material with a higher flexural modulus, correct?

18 A. Not the way that's stated. You would have to say it for

19 an identical geometry.

20 Q. For an identical geometry that would be true, correct?

21 A. For an identical geometry that statement is true.

22 Q. For an identical geometry the material of the inner layer,

23 HDPE, is actually less flexible, right, than the material of

24 the Pebax outer layer, correct.

25 A. For an identical geometry, that's correct.

734

1 Q. And let me just take this down.

2 For a scientist such as yourself, you can just go to

3 a reference book and look up flexural modulus, correct?


5 Q. If flexural modulus is the measurement -- I'm asking you

6 to assume that if it's a measurement of the flexibility of the

7 material as defined by the patent, then Boston Scientific

8 doesn't infringe, right?

9 A. I'm sorry. Would you rephrase that, please?

10 Q. Sure. I'm asking you to focus on the second paragraph of

11 the claim. Do you have that in mind?

12 A. Yes, I do.

13 Q. I'm asking you to focus on the portion that says, "said

14 material of the inner plastic layer being more flexible." Do

15 you have that in mind?

16 A. Yes.

17 Q. I'm asking you to assume that the correct way to measure

18 that is flexural modulus. I know you don't agree, but I'm

19 asking you to assume it.

20 If it is, Boston Scientific does not infringe that

21 claim, correct?

22 A. It would also be counter to the basic design of the

23 catheter, however.

24 Q. Right. It would be counter to the basic design of the

25 catheter, but the answer to my question is: If you use that

735

1 flexural modulus from the reference table, then Boston

2 Scientific doesn't infringe, correct?

3 A. The way that you have hypothetically phrased it, that's

4 correct.

5 Q. And you know that Dr. Cohen's opinion is that is the

6 correct way to determine it, correct?

7 A. Dr. Cohen and I disagree on the meaning of flexibility and

8 flexural modulus.

9 Q. Now, you testified in court on Thursday about

10 delamination. Do you remember that?

11 A. I recall that, yes.

12 Q. Had you ever seen a delaminated catheter?

13 A. I have not specifically seen a delaminated catheter. I

14 have seen delamination failures.

15 Q. And when you talked about clinically extreme and

16 inappropriate or dangerous conditions, you have never observed

17 delamination in a patient causing clinical conditions of any

18 kind, have you?

19 A. No, but I teach a medical device class and oftentimes make

20 reference to what the clinical failures might be and the

21 implications about seeing them personally.

22 Q. Now, do you believe that in order for a catheter to be

23 sold in the market -- let me ask you this. Withdrawn. I'm

24 sorry.

25 If there is a catheter on the market and there is a

736

1 one in a million chance that it could have a guidewire clog,

2 would that be suitable for its intended purpose?

3 A. Again, I think that's very specific to the application.

4 So I don't know that one in a million is appropriate or not

5 appropriate.

6 Q. Well, I'm asking you based upon your experience and the

7 classes that you have taught that you just described to me.

8 I'm asking you about it on the basis of what you said on

9 Thursday about clinical conditions and clinical risk.

10 If there is a product on the market that has a one in

11 a million risk of clogging the guidewire, is it fit for its

12 intended purpose?

13 A. Not if I'm that one in a million.

14 Q. Is that answer --

15 A. I can't answer specifically.

16 Q. Fair enough. So even with all your experience and your

17 teaching, you really can't tell us if that's an appropriate

18 standard or not, correct?

19 A. I think it depends very specifically on where a catheter

20 is used. A failure in a heart valve means death of patient. A

21 failure in a hip implant means a revision. I think it's very

22 specific to the application.

23 Q. Do you know if the Cordis Trakstar, which is on the market

24 and has been for years, has had guidewire clogging failures?

25 A. I don't know that specifically.

737

1 Q. Have you investigated that?

2 A. I have not looked into the Cordis product specifically,

3 no.

4 Q. Okay. Now, I want to ask you a little bit about this

5 delamination question. Did you do any study of the Conor

6 CoStar catheter?

7 A. I did not, sir.

8 Q. Do you know what it is?

9 A. I don't know the specifics of that catheter.

10 Q. Had you ever heard of it before?

11 A. I might have seen it in readings, but I don't recall any

12 details.

13 Q. So you don't know whether it -- who made it, whether it's

14 on the market or who tested it, correct?

15 A. No, I can't answer that as we speak.

16 Q. Now, I had asked you very early on this morning about

17 whether you had shown to the jury any of the actual documents

18 in the case.

19 MR. LEE: Can I have on the screen --

20 Q. I'm sorry. If you look in the notebook at DX-840 first?


22 Q. Do you have DX-840?

23 A. I do.

24 Q. Can you tell us what it is?

25 A. It's the "Maverick over the wire tri-layer preanneal," as

738

1 this is titled.

2 Q. Is this one of the documents that you have reviewed?

3 A. I'm sure I have seen this at some point in my engineering

4 drawing diagrams.

5 Q. Is this an accurate depiction of the Maverick catheter as

6 you understand it to exist?

7 A. As I understand it to exist, I would say so.

8 MR. LEE: We offer DX-840, your Honor.

9 MR. BAUMBARTNER: No objection, your Honor.


11 (Defendants' Exhibit 840 received in evidence)

12 MR. LEE: Can we have DX-840 on the screen? And

13 could we highlight the distal end view on the right-hand side?


15 Q. Have you seen this before?

16 A. I believe I have seen it in the context of the engineering

17 drawings, yes.

18 Q. And this is an engineering drawing of the actual -- an

19 actual Maverick catheter, correct?

20 A. Yes.

21 Q. And what we are looking at is the tri-layer inner tube,

22 correct?

23 A. Yes.

24 Q. And there is an inner layer, a middle layer and an outer

25 layer as described in the Boston Scientific documents, correct?

739


2 Q. And you believe that's an accurate depiction of the

3 Maverick as it is sold in the marketplace, correct?

4 A. Again, it's an accurate depiction just based on the

5 engineering drawings, so I would understand it to be

6 representative.

7 Q. And you know that Boston Scientific actually has sought

8 patent protection on tri-layer structures, has it not?

9 A. I don't know the details of that, I'm sorry.

10 Q. You have heard of Christine Byam?

11 A. I have heard her name, yes.

12 Q. Did you know that Christine Byam has a patent on a

13 tri-layer catheter structure?

14 A. I don't know the specifics of the other catheter

15 products --

16 Q. I'm sorry. Go ahead.

17 A. Okay. I was just saying, I don't know the specifics of

18 any patents that she may own.

19 Q. Fair enough. Turn, if you would, to PTX-355.


21 Q. Have you seen this patent before?

22 A. Again, if I had seen it, it would have been several years

23 ago, but not recently.

24 Q. When you say "several years ago," you have actually been

25 retained by Cordis for several years, correct?

740

1 A. Correct, yes.

2 Q. And you would have seen it in connection with this case,

3 correct?


5 MR. LEE: We offer PTX-355, your Honor, which is

6 stipulated to.

7 MR. BAUMBARTNER: No objection.


9 (Plaintiffs' Exhibit 355 received in evidence)

10 MR. LEE: Can I have PTX-355 on the screen

11 (displayed).

12 BY MR. LEE:

13 Q. You weren't here for the opening arguments, correct --

14 statements?


16 Q. Have you read them?

17 A. No, I have not.

18 Q. Now, this is a patent to Christine Samuelson and Sarah

19 Krieger, correct?

20 A. Yes. Those are the listed inventors, yes.

21 Q. And the application date is 1997, do you see that?

22 A. I see that.

23 Q. And if we go to the abstract, if we could.

24 "The present invention provides a length of

25 tri-layer extruded medical tubing comprising

741

1 an outer layer, a core layer and an

2 intermediate layer. The outer layer

3 comprises a polymer that is directly

4 bondable, while the core layer comprises a

5 lubricious polymer. The core layer, thus,

6 defines a lumen that exhibits the desired

7 characteristics, i.e., low friction for the

8 advancement of a guidewire or catheter

9 through the lumen without compromising the

10 strength and stiffness that is desirable in

11 tubing that is to be used in medical devices.

12 "Additionally, the tubing is easily

13 co-extruded, yet, is not subject to

14 delamination. Thus, providing the added

15 advantage of providing a reduction in the

16 overall costs of manufacture."


18 A. Yes, you have.

19 Q. You know Christine Samuelson is now Christine Byam as a

20 result of marriage; did you know that?

21 A. I didn't know that specifically, no.

22 Q. Well, I will represent that to you.

23 A. Okay.

24 Q. So you have looked at the abstract I have just read. That

25 accurately describes the Maverick, doesn't it?

742

1 A. Again, I'm just relying on what you have just read to me

2 here.

3 Q. Well, do the words that I have just read to you, Dr.

4 Pruitt, accurately describe the Maverick as you have described

5 it to the jury?

6 A. They appear to describe the Maverick.

7 Q. And this -- the Patent Office got Miss Samuelson, now Miss

8 Byam's application and they issued her a patent, correct?

9 A. It appears so, yes.

10 Q. And you know that when you have a patent issued, there

11 must be something new and different about it, correct?

12 A. That's my understanding, yes.

13 Q. There must be something more than insubstantially

14 different, correct?

15 A. That is my understanding of patent law, yes.

16 Q. And on Thursday you told the jury that you could infringe

17 if you were insubstantially different, correct?

18 A. I think I said that if the claim language covers a

19 product, that product is infringing on a patent. And then I

20 just gave an analysis of doctrine of equivalence.

21 Q. Right. But you know that if a patent issues, the Patent

22 Office thought that there was something substantially different

23 about the new invention, correct?

24 A. That's my understanding of how a patent works, yes.

25 Q. Now, if we could, could I show the diagram on the front

743

1 page of the patent?


3 Q. Do you see the diagram on the front page of the patent?

4 A. Yes, I do.

5 Q. And that diagram in this patent describes an inner tube

6 with three different layers, does it not?

7 A. It appears to, from this particular drawing, to have three

8 layers.

9 Q. Right. It looks an awful lot like the document we just

10 saw, DX-840, correct?

11 A. And DX-840, remind me please, is --

12 Q. DX-840 --

13 A. Okay.

14 Q. DX-840 was the Boston Scientific drawing.

15 A. Maverick.

16 Q. Do you see that?

17 A. I do.

18 Q. Now, give me a second and I will get to the right page

19 here.

20 MR. LEE: May I approach the screen, your Honor?

21 THE COURT: You may.

22 BY MR. LEE:

23 Q. Dr. Pruitt, on the left-hand side there is a list of

24 references cited, "U.S. Patent Documents, Foreign Patent

25 Documents." Have you seen those?

744

1 A. I do.

2 Q. And you are familiar with what this means, correct?

3 A. Vis-a-vis other documents or patents that are cited.

4 Q. And that the Patent Office had before it, correct?

5 A. That's my basic understanding.

6 Q. Let's look at the U.S. patent documents and it says, "List

7 continued on next page." Have you got that?

8 A. I do.

9 Q. And if you go to the next page, you will see on the

10 right-hand side, four from the bottom, that the Patent Office

11 had the '594 Fontirroche patent before it, correct?

12 A. I see Fontirroche listed here.

13 Q. So the one thing that the jury knows is that there was a

14 patent application filed by Boston Scientific. They included a

15 tri-layer structure like that of the Maverick. The Patent

16 Office had the Fontirroche patent before it, and it gave her

17 another patent, correct?

18 A. That's the interpretation.

19 Q. It would appear from the record that the Patent Office

20 concluded that there was a substantial difference between the

21 tri-layer structure of Miss Byam and the Fontirroche patent,

22 correct?

23 A. Again, I'm not a patent attorney, but that's as it

24 appears.

25 Q. And that would be the opposite of the conclusion you

745

1 reached on equivalence, correct?

2 A. Again, I'm assessing whether that -- the Boston Scientific

3 products infringe a specific claim of the Fontirroche patent.

4 MR. LEE: Can I have Dr. Pruitt's demonstrative on

5 the doctrine of equivalence?

6 Q. I think you have a hard copy before you, but I'm going to

7 put it on the screen.


9 Q. This is DX-3012, Dr. Pruitt, correct?

10 A. Correct.

11 Q. And this is where you applied the, Function, Way, Result

12 test. And you said the Function is, "Allows the formation of a

13 multi-layer guidewire tube."


15 Q. The Way is, "holds the layers together so they cannot be

16 separated," correct?


18 Q. And then it says, "the guidewire tube does not

19 delaminate," correct?


21 Q. That would apply to any physical bond, wouldn't it?

22 A. It would apply to any physical bond that would satisfy

23 these conditions.

24 Q. Any physical bond that allows for the formation of a

25 multi-layer guidewire tube that holds the layers together so

746

1 they cannot separate and then the guidewire does not delaminate

2 would, in your view, be equivalent?

3 A. If the physical bond satisfies the Function, Way, Result's

4 condition.

5 Q. But, of course, if we accept that, then the Asuka catheter

6 would be just one of these, wouldn't it?

7 A. Again, I would need to study the Asuka catheter, but from

8 what we have discussed, it appears that way.

9 Q. So your equivalence analysis covers precisely what Cordis

10 told the Patent Office its invention was not, correct?

11 A. Again, I made this specific Function, Way, Result,

12 analysis to evaluate a functional bond to the chemical bond.

13 Q. Right. But, Dr. Pruitt, we now know what Cordis told the

14 Patent Office about the Asuka catheter, correct?

15 A. Correct.

16 Q. We know that it distinguishes -- it distinguished the

17 Asuka because it did not have a chemical bond, correct?

18 A. That's my understanding from what we --

19 Q. You know what Mr. Trotta said about the tie layers and how

20 they're different, correct?

21 A. Again, I disagree with the assessment of the tie layer

22 discussion as I understand it.

23 Q. But Mr. Trotta won't be here, so we won't be able to ask

24 him, will we?

25 A. I don't know anything about that. I'm sorry.

747

1 MR. LEE: Nothing further, your Honor.

2 THE COURT: Thank you. Mr. Baumgartner?

3 REDIRECT EXAMINATION

4 MR. BAUMBARTNER: May we have Plaintiff's Exhibit 355

5 displayed, please?


7 Q. Professor Pruitt, this is the later patent of Christine

8 Byam that you were asked about, Plaintiff's Exhibit 355?

9 A. Yes, that's correct.

10 Q. Let's take a look at Claim One of this patent. Claim One

11 of the patent refers to a length of co-extruded flexible

12 tubing, do you see that?

13 A. I do.

14 Q. And then it gives a laundry list of things that have to be

15 satisfied in order for the invention of this patent to be used;

16 do you see that?

17 A. I do.

18 Q. One of them is:

19 "Wherein the first, second and third glass

20 transition temperatures are within 85 percent

21 to 115 percent of the glass transition of the

22 layer or layers adjacent thereto."

23 Do you see that?


25 Q. How specific is that requirement?

748

1 A. That's a very specific requirement.

2 Q. Would that cover all tri-layer catheter designs?

3 A. I don't know unless they cover that specific requirement

4 on glass transition temperature.

5 Q. Now, let's assume just for the sake of discussion that

6 this patent does cover the design of the guidewire tube in the

7 Maverick family of products.

8 Does that mean that the Maverick family of products

9 does not infringe the Fontirroche '594 patent?

10 MR. LEE: I object to the form.



13 Q. If we make that assumption, does that affect your

14 conclusion that the Fontirroche '594 patent is infringed by the


16 A. No. My understanding is that if a product infringes each

17 and claim element, then it's infringing on that patent.

18 Q. Let me give you a hypothetical, Professor Pruitt. Let's

19 suppose we have the patent on the first bicycle ever invented.

20 Can you assume that?

21 A. Yes.

22 Q. And let's suppose someone later comes along with a refined

23 bicycle that has a new fender design. Can you assume that?

24 A. Sure.

25 Q. And let's assume that the second inventor gets a patent on

749

1 the bike with the new fender design. Can you assume that?

2 A. Yes.

3 Q. Now, if you make a bike with the new fender design, does

4 the fact that the new fender design is patented mean that that

5 bike does not infringe the original patent on all bikes?

6 A. Again, I'm not a patent attorney, so I can't say that the

7 restriction would apply there. Just because we have a new

8 fender, doesn't mean that the bike might not infringe.

9 Q. Because you can infringe two patents at the same time,

10 right?




14 Q. Now, could you get a patent on the new fender design even

15 if the Patent Office knew about the earlier patent on all

16 bikes?



19 BY THE COURT:

20 Q. You were asked some questions about some testimony that

21 Mr. Trotta gave in another proceeding. Do you recall that?

22 A. I recall that, yes.

23 MR. BAUMBARTNER: Could we have page 719 of the

24 testimony in the other proceeding displayed, please?

25 THE COURT: Mr. Trotta's?

750

1 MR. BAUMBARTNER: Yes.



4 Q. Now, I would like to direct your attention, Professor

5 Pruitt, to the beginning of this discussion with Mr. Trotta

6 here on line 12.

7 The question is asked:

8 "QUESTION: Would you turn over to page 22 of

9 Defendant's Exhibit 30, Bates 23044. What is

10 the date of that entry?

11 "ANSWER: It's dated December 8th, 1992.

12 "QUESTION: Do you have the original

13 laboratory notebook with you?

14 "ANSWER: Yes, I do."

15 And then there is some further discussion and the

16 question is asked:

17 "QUESTION: Now, down near the bottom of the

18 page there is some text that reads, 'Trying

19 to obtain information and sample of Plexar

20 209 HDPE based tri-layer for co-extrusion.

21 The idea is here to either, one, co-extrude

22 nylon over the HDPE based tie layer material.

23 This would yield the properties of

24 polyethylene lubricity on the inside while

25 maintaining nylon 12 on the outside for

751

1 sealing purposes and stiffness.'

2 "Then the entry continues. Do you see that

3 sir?"

4 And the answer is:

5 "ANSWER: Yes, I do.

6 "QUESTION: Do you know whose handwriting

7 that entry is in?

8 "ANSWER: Steve's."

9 Q. Do you understand that to be a discussion of an entry in a

10 particular Cordis laboratory notebook?

11 A. That's my understanding as you read it, yes.

12 Q. And then the questioning continues, and Mr. Lee referred

13 you to some of the question and answers about that laboratory

14 notebook entry, correct?

15 A. Yes.

16 Q. Now, is what's covered by Claim 7 of the Fontirroche '594

17 patent determined by the claim or determined by entries in a

18 laboratory notebook?


20 THE COURT: Sustained. We are going back and forth

21 on this, ladies and gentlemen, because there is a tricky

22 intersection between fact and law in patent cases, as you can

23 probably imagine. In my view, these questions have been

24 question of law, which is why I'm sustaining the objection to

25 them.

752

1 But you can ask about any facts you like, Mr.

2 Baumgartner.

3 MR. BAUMBARTNER: Thank you, your Honor.


5 Q. When you examined the question of whether the Fontirroche

6 '594 patent was infringed, did you think it was important to

7 look at laboratory notebook entries?

8 A. Again, it was my understanding that I was to look at the

9 products and to see if they satisfied the claim elements in

10 Claim 7 of the '594 patent and that would -- would tell me

11 whether I had infringement or not.

12 Q. Now, you were also pointed to the deposition of

13 Mr. Fontirroche, where he was asked about whether he did any

14 experiments with a tri-layer structure. Do you recall that?

15 A. I recall that basic question.

16 Q. And he said he couldn't recall one way or the other?

17 A. Yes.

18 Q. To decide whether there was infringement in this case, did

19 you feel it was necessary to see if the Cordis inventors had

20 done experiments with the exact design that is used in the

21 guidewire tube of the Maverick family of products?

22 A. No, I did not.

23 Q. Why not?

24 A. Again, I read the claim language of the '594 patent and

25 looked to whether the Maverick products satisfied those

753

1 elements for infringement.

2 Q. Let's turn now to a different subject, which is your

3 doctrine of equivalence analysis.

4 When you cut open the guidewire tube in the Maverick

5 family of products and you tried to separate the Plexar layer

6 from the HDPE layer, how hard was it to separate those?

7 A. I was unable to separate those under any applied force

8 that I could exert.

9 Q. Now, you said that the Asuka catheter was only held

10 together by friction?

11 A. That would be my understanding, yes.

12 Q. Let me ask you to assume that Mr. Kastenhofer did tests on

13 the Asuka catheter and found they delaminated. Can you make

14 that assumption for me?

15 A. I can make that assumption, yes.

16 Q. If the evidence in this case were to demonstrate that that

17 assumption was true, would the frictional bond in Asuka be the

18 equivalent of the chemical bond that's required by the


20 A. No, because the result of my Function, Way, Result

21 analysis is that we have a guidewire tube that does not

22 delaminate.

23 Q. So when you gave the testimony before about the Asuka

24 product, you were assuming that the layer wouldn't come apart?

25 A. Yes. In order to satisfy my doctrine of equivalence, I

754

1 would have to satisfy that it would not have, no delamination

2 would be there.

3 Q. And did you make that assumption because Mr. Lee asked you

4 to or because you had investigated the Asuka catheter?

5 A. I have not investigated the Asuka catheter personally.

6 Q. Now, you were asked some questions about Defendant's

7 Exhibit 6, which Mr. Lee said was a prosecution history for a

8 Fontirroche patent. Do you recall that?

9 A. I recall the question.

10 MR. BAUMBARTNER: Could we have Defendant's Exhibit 6

11 displayed?


13 Q. Now, if you will turn over to the second page of this

14 exhibit, the patent number of the patent that issued from this

15 application is shown here. Can you read that for us, Professor

16 Pruitt?

17 A. Yes. It reads 5,538,510.

18 Q. And do you understand that Mr. Fontirroche has got more

19 than one patent?

20 A. Yes. I understand he has several patents.

21 Q. Is this the number of the patent that you came here to

22 testify about?

23 A. No. As we see there, I'm testifying on the '594 patent,

24 Claim 7.

25 Q. So this prosecution history you were asked about is a

755

1 different prosecution than the '594 patent?

2 MR. LEE: I object. That's a conclusion and that's

3 not true, since it is part of the family.

4 THE COURT: The objection is sustained. Why don't

5 you reframe the question so it doesn't assume anything

6 incorrectly?

7 MR. BAUMBARTNER: All right, your Honor.


9 Q. What relationship is there between the patent number of

10 the prosecution history you were asked about and the patent

11 number of the claim you testified about on Thursday?

12 A. All I know is that this is the prosecution history for a

13 different patent and I don't know what the prosecution history

14 looks like for the '594 patent.

15 Q. Now, you were asked some questions in this prosecution

16 history for a different patent about the Hamlin patent, that

17 was an European patent, do you recall that?

18 A. I recall that question, yes.

19 Q. And did you get a chance to look a little bit more at the

20 Hamlin patent during the break that we had?

21 A. Yes. In the break I just had an opportunity to briefly

22 review the Hamlin patent.

23 Q. Did you see any reference in the -- well, let me back up.

24 The Hamlin patent, does that relate to a balloon or does it

25 relate to a guidewire tube?

756

1 A. I think, as we said earlier in the testimony, it relates

2 to a balloon, not a catheter.

3 Q. And in the balloon, how many layers are there, as you

4 understand it?

5 A. As was disclosed here, we had three layers as was

6 described.

7 Q. Did you see any discussion in the Hamlin patent about

8 there being a chemical bond between any of the three layers?

9 A. When I reread the patent, I did not see any discussion of

10 a chemical bond, no.

11 Q. Now, let's take a look at page 19001 in Defendant's

12 Exhibit 6.

13 Do you remember Mr. Lee asked you some questions

14 about what the Cordis lawyer said to the Patent Office about

15 the Hamlin patent?

16 A. I recall that question, yes.

17 Q. And look at the bottom of this page where the lawyer

18 continues. At the very bottom:

19 "It should be noted that the Hamlin

20 European patent application relates to a

21 process for making multi-layer angioplasty

22 balloons and not for making catheter tubing

23 that extends most of the length of the

24 catheter and is not expansible as preferred

25 in this present application."

757

1 Based on your review of the Hamlin patent during the

2 break, is that statement true?

3 A. Yes.

4 Q. Then it continues:

5 "Furthermore, the multiple layers of the

6 balloon of the Hamlin European publication do

7 not appear to be chemically bonded together."

8 Do you see that?

9 A. I do. May we have Defendant's Exhibit 3014 displayed,

10 please?


12 MR. BAUMBARTNER: Your Honor, is a demonstrative that

13 we used last week.

14 Q. Now, you understand that in the Fontirroche '594 patent,

15 Claim 7, that there needs be a chemical bond between the inner

16 layer of the guidewire tube and the outer layer?

17 A. I understand that we need to have the presence of a

18 chemical bond and that the two layers need to be bonded to each

19 other.

20 Q. Does the claim language specify exactly where the chemical

21 bond must be located?

22 A. No, it does not.

23 MR. BAUMBARTNER: Thank you. I have no further

24 questions.

25 THE COURT: Thank you. Anything further, Mr. Lee?

758

1 RECROSS EXAMINATION

2 MR. LEE: Can I have DX-1 on the screen, please, the

3 cover?


5 Q. Do you have it there, Dr. Pruitt?

6 A. I do.

7 Q. I want to ask you some questions about Mr. Baumgartner's

8 questions about the file history that you have reviewed.

9 MR. LEE: Could we have blown up the portion that

10 says, "Related U.S. Application Data"?


12 Q. This is the patent that did you give some time to,

13 correct?

14 A. The '594, yes.

15 Q. It says right on its cover that:

16 "This is a continuation in part of serial

17 number 189209, January 31, 1994, patent

18 No. 5,538,510."

19 Do you see that?

20 A. I do.

21 Q. And that is the very patent for which we have looked at

22 the file history, correct?


24 Q. So that the Fontirroche '594 patent is in this family of

25 patents and when the patent office -- when they applied to the

759

1 patent office, they said to them, "Is this related to the '510

2 patent," correct?

3 A. Again, I'm not a lawyer, but my understanding it would be

4 related, yes.

5 Q. Okay. Now, the second topic, and just two more topics.

6 A. Okay.

7 Q. Mr. Baumgartner asked you some questions about what was

8 relevant or important to your opinion on infringement.

9 Dr. Pruitt, you came here on Thursday and you put

10 specific portions of the specification on the screen and you

11 told the jury what they meant, correct?


13 Q. It would have been good to know what Mr. Fontirroche

14 thought they meant, correct?

15 A. Again, I can't speak to Mr. Fontirroche's presence.

16 Q. Based upon your own experience publishing peer reviewed

17 articles, making presentations for your peers, if you are going

18 to talk about what the specification meant, it would have been

19 useful to know what the people who wrote it thought, correct?

20 A. Sometimes, for whatever reason, people can't be places. I

21 rely on my doctoral students to carry my message many times at

22 conferences. I can't say why he's not here.

23 Q. Were you ever asked to meet with Mr. Fontirroche?

24 A. I met with Mr. Trotta and I thought that that was

25 equivalent.

760

1 Q. Did you ever ask to talk to him by telephone?

2 A. To Mr. Fontirroche?

3 Q. Yes.

4 A. No. I flew down to Cordis and met with Mr. Trotta.

5 Q. Now, the last question. Isn't it true, Dr. Pruitt, that

6 the only witness that this jury is going to hear from Cordis on

7 the question of Boston Scientific's infringement of the

8 Fontirroche patent is you?

9 A. I don't -- I don't really know what the witness list looks

10 like.

11 Q. Do you know anybody else who is going to testify about

12 this patent?

13 A. I don't know what the witness list looks like. I'm sorry.

14 MR. LEE: Nothing further, your Honor.

15 MR. BAUMBARTNER: Just one brief line of inquiry,

16 your Honor.

17 REDIRECT EXAMINATION

18 Q. Professor Pruitt, when the Cordis patent lawyers were

19 talking to the Patent Office about the '510 patent and they

20 made statements about what was and what was not covered by the

21 claims in that application, would they have been talking, do

22 you think, about the claims in the '510 patent or would they

23 have been talking about the claims in the '594 patent that you

24 address?

25 A. It would be my understanding that that correspondence

761

1 would be specific to the claims of the '510 patent, for the

2 '510 correspondence.

3 Q. Thank you. Nothing further.

4 THE COURT: May the witness step down.

5 MR. LEE: Yes. Nothing further, your Honor.

6 THE COURT: Thank you very much. You are excused.

7 (Witness excused.)

8 THE COURT: Okay. Defense may call its next witness.

9 MR. PRITIKIN: Yes, your Honor. Our next witness is

10 Dr. David Roberts and Mr. Harris will ask the questions of

11 Dr. Roberts.

12 DAVID ROBERTS,


14 duly sworn, was examined and testified as follows:


16 THE CLERK: Thank you. Please state your full name

17 for the record.

18 THE WITNESS: Yes. It's David Roberts.

19 THE CLERK: Roberts, R-O-B-E-R-T-S?

20 THE WITNESS: Correct.

21 MR. HARRIS: May proceed, your Honor.

22 DIRECT EXAMINATION

23 BY MR. HARRIS:

24 Q. Good morning, Dr. Roberts. Good morning, your Honor.

25 Dr. Roberts, what is your profession?

891

1 I N D E X

2

3 DEFENDANT'S WITNESSES PAGE VOL.

4 PRUITT, LISA (SWORN) 658 4 5 Cross Examination by Mr. Lee 659 4 Redirect Examination by Mr. Baumgartner 747 4 6 Recross Examination Resumed by Mr. Lee 758 4 Redirect Examination by Mr. Baumgartner 760 4 7

8 ROBERTS, DAVID (SWORN) 761 4 9 Direct Examination by Mr. Harris 761 4 Cross Examination by Mr. Massa 788 410

11 ROBINSON, JANINE (SWORN) 809 412 Direct Examination by Mr. Pritikin 810 4

13

14 E X H I B I T S

15 PLAINTIFF'S EXHIBITS IDEN VOL. EVID VOL.16 PTX-355 740 417

18 DEFENDANT'S EXHIBITS IDEN VOL. EVID VOL.

19 DX-1 660 4 DX-6 681 420 DX-840 738 4 DX-2336A 840 421 DX-2367 857 4

22

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25

892

1

2 CERTIFICATE OF REPORTER

3 We, KATHERINE A. POWELL and DEBRA L. PAS, Official

4 Reporters for the United States Court, Northern District of

5 California, hereby certify that the foregoing proceedings in

6 C 02-0790 SI, Boston Scientific Corporation vs. Cordis

7 Corporation, were reported by us, certified shorthand

8 reporters, and were thereafter transcribed under our direction

9 into typewriting; that the foregoing is a full, complete and

10 true record of said proceedings as bound by us at the time of

11 filing.

12 The validity of the reporters' certification of said

13 transcript may be void upon disassembly and/or removal

14 from the court file.

15

16 ________________________________________

17 Katherine A. Powell, CSR 5812, RPR, CRR

18

19 ________________________________________

20 Debra L. Pas, CSR 11916, CRR, RMR, RPR

21

22 Monday, October 15, 2007

23

24

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