throbber
Patent Owners CDx Diagnostics Inc./Shared
`Medical Resources ----Exh. 2005
`U.S. Endoscopy Group v. CDx Diagnostics Inc.
`and Shared Medical Resources, LLC
`IPR2014-00642
`
`Page 1
`
`··
`
`··UNITED STATES PATENT AND TRADEMARK OFFICE
`
`··BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`··-----------------------------------x
`
`··U.S. ENDOSCOPY GROUP, INC.,· · · ··:
`
`
`
`· · · · · · · · · · · · Petitioner,· ·:
`
`
`
`· · · · · ·· -against-· · · · · · · ··: Case No.
`
`··CDX DIAGNOSTICS, INC., and· · · · ·: IPR2014-00642
`
`··SHARED MEDICAL RESOURCES, LLC,· · ·: Patent No.
`
`
`
`· · · · · · · · · · · · Patent Owners.: 6,258,044
`
`··-----------------------------------x
`
`
`
`· · · · · · · · · · · · December 8, 2014
`
`
`
`· · · · · · · · · · · · 10:15 a.m.
`
`··
`
`· · · Deposition of MICHEL KAHALEH, M.D., held
`
`··at the office of Dr. Michel Kahaleh, M.D.,
`
`··Weil-Cornell Medical Center, 4th floor, 1305 York
`
`··Avenue, New York, New York, before Roberta Caiola,
`
`··a Shorthand Reporter and Notary Public within and
`
`··for the State of New York.
`
`··
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`··
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`··
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`··
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`··
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`REPORTERS CENTRAL, LLC * 212-594-3582
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`

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`Page 2
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`··1·
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`·2·
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`·A P P E A R A N C E S:
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`··3·
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`·4·
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`·CALFEE, HALTER & GRISWOLD LLP
`
`·5·
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`·Attorneys for Petitioner
`
`·6·
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`
`
`· · ·· The Calfee Building
`
`·7·
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`
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`· · ·· 1405 East Sixth Street
`
`·8·
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`
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`· · ·· Cleveland, Ohio 44114-1607
`
`·9·
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`·BY:··TODD R. TUCKER, ESQ.
`
`10·
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`
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`· · ·· ttucker@calfee.com
`
`·11·
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`12·
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`·LEVISOHN BERGER LLP
`
`13·
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`·Attorneys for Patent Owner:
`
`14·
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`
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`· · ·· 11 Broadway, Suite 615
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`15·
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`
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`· · ·· New York, New York 10004
`
`16·
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`·BY:··PETER L. BERGER, ESQ.
`
`17·
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`
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`· · · · · · -and-
`
`18·
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`
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`· · ·· TUVIA ROTBERG, ESQ.
`
`·19·
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`20·
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`·ALSO PRESENT:
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`21·
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`
`
`· · ·· FRANK FROMOWITZ
`
`·22·
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`·23·
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`·24·
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`·25·
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`Page 3
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`··1·
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`·2·
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`
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`· · · · · · THE COURT REPORTER:··Raise your right
`
`·3·
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`· ·· hand please.··Do you swear the testimony that
`
`·4·
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`· ·· you are about to give will be the truth, the
`
`·5·
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`· ·· whole truth, and nothing but the truth?
`
`·6·
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`
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`· · · · · · THE WITNESS:··I swear.
`
`·7·
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`·M I C H E L· ·K A H A L E H , M.D.,
`
`·8·
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`· ·· having been duly sworn by the Notary Public,
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`·9·
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`· ·· Roberta Caiola, was examined and testified as
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`10·
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`· ·· follows:
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`11·
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`
`
`· · · · · · MR. BERGER:··Mark this as Exhibit 1.
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`12·
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`
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`· · · · · · (Exhibit 1, Document entitled
`
`13·
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`· ·· "U.S. Endoscopy Group, Inc. vs. CDx Diagnostics
`
`14·
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`· ·· Inc. and Shared Medical Resources LLC, marked
`
`15·
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`· ·· for identification, as of this date.)
`
`16·
`
`·EXAMINATION BY
`
`17·
`
`·MR. BERGER:
`
`18·
`
`· ·· Q.· · ·Good morning, Dr. Kahaleh.
`
`19·
`
`
`
`· · · · · · Did you ever give a deposition before?
`
`20·
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`· ·· A.· · ·Yes.
`
`21·
`
`· ·· Q.· · ·How many times?
`
`22·
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`· ·· A.· · ·Maybe ten.
`
`23·
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`· ·· Q.· · ·Have you ever been involved in a patent
`
`24·
`
`·litigation?
`
`25·
`
`· ·· A.· · ·Actually, no.
`
`REPORTERS CENTRAL, LLC * 212-594-3582
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`

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`Page 4
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`· ·· Q.· · ·Do you have any patents?
`
`·3·
`
`· ·· A.· · ·I have pending patents, or a shared
`
`·4·
`
`·patent actually with the UVA.
`
`·5·
`
`· ·· Q.· · ·Do you recall what you've looked at in
`
`·6·
`
`·terms of what you've done for this project?
`
`·7·
`
`· ·· A.· · ·Yes.
`
`·8·
`
`· ·· Q.· · ·What have you looked at?
`
`·9·
`
`· ·· A.· · ·I've looked at a specific brush.
`
`10·
`
`· ·· Q.· · ·Which brush is that?
`
`11·
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`· ·· A.· · ·The biliary brush.
`
`12·
`
`· ·· Q.· · ·That is the biliary brush of the patent,
`
`13·
`
`·the Parasher patents, or is it a U.S. Endoscopy
`
`14·
`
`·patent?
`
`15·
`
`· ·· A.· · ·The U.S. Endoscopy patent.
`
`16·
`
`· ·· Q.· · ·Did you ever see the brush that's in the
`
`17·
`
`·Parasher patent, that brush?
`
`18·
`
`· ·· A.· · ·I've seen it, yes.
`
`19·
`
`· ·· Q.· · ·Where?
`
`20·
`
`· ·· A.· · ·I've seen it, we have it in our unit, and
`
`21·
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`·also I've seen it many times during medical
`
`22·
`
`·conferences.
`
`23·
`
`· ·· Q.· · ·Do you know the brush that you've seen,
`
`24·
`
`·is that an old brush or a relatively new brush; any
`
`25·
`
`·idea?
`
`REPORTERS CENTRAL, LLC * 212-594-3582
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`

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`Page 5
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`· ·· A.· · ·This brush has been around from now a
`
`·3·
`
`·little bit more than a year and a half.
`
`·4·
`
`· ·· Q.· · ·Is it called a Parasher brush by the way?
`
`·5·
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`· ·· A.· · ·The CDx brush is called like this. The
`
`·6·
`
`·U.S. Endoscopy is called the Infinity brush.
`
`·7·
`
`· ·· Q.· · ·The CDx brush you're calling the Parasher
`
`·8·
`
`·brush?
`
`·9·
`
`· ·· A.· · ·Yeah, that's the name.
`
`10·
`
`· ·· Q.· · ·Okay.
`
`11·
`
`
`
`· · · · · · We represent CDx, we have the EndoCDx
`
`12·
`
`·brush.··Parasher is the patent that was gotten in
`
`13·
`
`·1998, that's why there's confusion.
`
`14·
`
`· ·· A.· · ·Okay.
`
`15·
`
`· ·· Q.· · ·Have you ever seen the brush that's the
`
`16·
`
`·subject of the 1998 patent?
`
`17·
`
`· ·· A.· · ·The very original one?
`
`18·
`
`· ·· Q.· · ·Yes.
`
`19·
`
`· ·· A.· · ·Is it different from the current one?
`
`20·
`
`· ·· Q.· · ·I don't know.··It's described in the
`
`21·
`
`·patent in 1998.··I wonder if you've ever seen that?
`
`22·
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`· ·· A.· · ·My understanding is that whatever brush
`
`23·
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`·there is now, that's the one that's on the market,
`
`24·
`
`·that's the one that I'm using.
`
`25·
`
`
`
`· · · · · · MR. TUCKER:··I'm going to object to the
`
`REPORTERS CENTRAL, LLC * 212-594-3582
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`

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`Page 6
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`·1·
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`
`
`· · · · · · · · M. Kahaleh
`
`·2·
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`· ·· whole line of questioning because it's beyond
`
`·3·
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`· ·· the scope of his declaration, he didn't opine
`
`·4·
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`· ·· on one brush.··Go ahead.
`
`·5·
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`
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`· · · · · · MR. BERGER:··Dr. Fromowitz is with us.
`
`·6·
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`
`
`· · · · · · (At this time Dr. Fromowitz has
`
`·7·
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`· ·· joined the deposition.)
`
`·8·
`
`· ·· Q.· · ·There is on the market a CDx brush called
`
`·9·
`
`·EndoCDx; are you familiar with that?
`
`10·
`
`· ·· A.· · ·We just call it a CDx, yes.
`
`11·
`
`· ·· Q.· · ·Then there's a brush on the market called
`
`12·
`
`·the U.S. Endoscopy brush?
`
`13·
`
`· ·· A.· · ·Yes.
`
`14·
`
`· ·· Q.· · ·Are there any other brushes that you deal
`
`15·
`
`·with that are of this type?
`
`16·
`
`· ·· A.· · ·Yes.··I deal with the Boston Scientific
`
`17·
`
`·brush and I deal with the Cook brush.
`
`18·
`
`· ·· Q.· · ·So when I then talked about a Parasher
`
`19·
`
`·patent, let me just show you.··As Mr. Tucker said
`
`20·
`
`·you may have never seen the patent, I don't know,
`
`21·
`
`·I'll just show it to you. I won't mark it yet,
`
`22·
`
`·we'll get there later.
`
`23·
`
`
`
`· · · · · · Do you recall ever seeing this document
`
`24·
`
`·in your review?
`
`25·
`
`
`
`· · · · · · MR. TUCKER:··Again, I'm going to object,
`
`REPORTERS CENTRAL, LLC * 212-594-3582
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`

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`Page 7
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`· ·· it's beyond the scope of his declaration and
`
`·3·
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`· ·· I'll move to exclude at the appropriate time.
`
`·4·
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`· ·· A.· · ·Okay.
`
`·5·
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`· ·· Q.· · ·Did you ever see that before?
`
`·6·
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`· ·· A.· · ·No.··That specific document, no.
`
`·7·
`
`· ·· Q.· · ·Thank you.
`
`·8·
`
`
`
`· · · · · · The opinions you've given reflect your
`
`·9·
`
`·current state of knowledge as of 2014?
`
`10·
`
`· ·· A.· · ·Yes.
`
`11·
`
`· ·· Q.· · ·When did you graduate from medical
`
`12·
`
`·school?
`
`13·
`
`· ·· A.· · ·1994.
`
`14·
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`· ·· Q.· · ·What were you doing in 1998?
`
`15·
`
`· ·· A.· · ·In 1998?
`
`16·
`
`· ·· Q.· · ·Yes.
`
`17·
`
`· ·· A.· · ·What was I doing in 1998.
`
`18·
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`· ·· Q.· · ·Let me make your life simple.
`
`19·
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`· ·· A.· · ·In 1998 I was doing my training in
`
`20·
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`·internal medicine.
`
`21·
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`· ·· Q.· · ·If you had rendered an opinion in 1998
`
`22·
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`·about the subject matter that you've rendered this
`
`23·
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`·opinion in this case about, would it be the same,
`
`24·
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`·would it be different, do you have any idea?
`
`25·
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`
`
`· · · · · · MR. TUCKER:··Objection.
`
`REPORTERS CENTRAL, LLC * 212-594-3582
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`

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`Page 8
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`· ·· A.· · ·There was not a biliary endoscopy in
`
`·3·
`
`·1998.
`
`·4·
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`· ·· Q.· · ·Would it be fair to say that you would
`
`·5·
`
`·not have been able to offer an opinion with the
`
`·6·
`
`·state of your knowledge as of 1998, is that fair?
`
`·7·
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`· ·· A.· · ·It's fair.··I was only an intern in
`
`·8·
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`·internal medicine.
`
`·9·
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`· ·· Q.· · ·That's fine.··Would you tell me what you
`
`10·
`
`·understand a biopsy to mean?
`
`11·
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`· ·· A.· · ·A biopsy is a specimen that is taken from
`
`12·
`
`·an epithelium, the area just below the epithelium
`
`13·
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`·with a device, so it typically includes mucosa and
`
`14·
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`·submucosa.
`
`15·
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`· ·· Q.· · ·Are there biopsies which do not take all
`
`16·
`
`·those three layers?
`
`17·
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`· ·· A.· · ·Yeah, if it's a very superficial biopsy
`
`18·
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`·it could do that.··If you take like a very, very
`
`19·
`
`·superficial one, by accident or not, you could
`
`20·
`
`·eventually take less, but it's very unusual.··Most
`
`21·
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`·biopsies include at least epithelium and submucosa.
`
`22·
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`· ·· Q.· · ·What are cells?
`
`23·
`
`· ·· A.· · ·What are cells?
`
`24·
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`· ·· Q.· · ·Cells, yeah.
`
`25·
`
`· ·· A.· · ·Cells are the basic component of the
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`REPORTERS CENTRAL, LLC * 212-594-3582
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`Page 9
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`·architecture of any layer.
`
`·3·
`
`· ·· Q.· · ·What's tissue?
`
`·4·
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`· ·· A.· · ·Tissue is a combination of different
`
`·5·
`
`·layers that will constitute the covering of an
`
`·6·
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`·organ.
`
`·7·
`
`· ·· Q.· · ·What was the last word?
`
`·8·
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`· ·· A.· · ·Organ.
`
`·9·
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`· ·· Q.· · ·When you say tissue does it always have
`
`10·
`
`·lawyers?
`
`11·
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`· ·· A.· · ·Yes.··Any tissue has layers.··Yes, tissue
`
`12·
`
`·always has layers.
`
`13·
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`· ·· Q.· · ·Does the tissue always have submucosa?
`
`14·
`
`· ·· A.· · ·Yes.
`
`15·
`
`· ·· Q.· · ·Does tissue always have basement
`
`16·
`
`·membrane?
`
`17·
`
`· ·· A.· · ·Yes.
`
`18·
`
`· ·· Q.· · ·I have brought with me a complete
`
`19·
`
`·dictionary, I have only certain pages marked of the
`
`20·
`
`·dictionary.
`
`21·
`
`· ·· A.· · ·Okay.
`
`22·
`
`· ·· Q.· · ·The dictionary is Stedman's Concise
`
`23·
`
`·Medical Dictionary For The Health Professions,
`
`24·
`
`·Illustrated/Third Edition, it has a copyright date
`
`25·
`
`·of 1997.
`
`REPORTERS CENTRAL, LLC * 212-594-3582
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`Page 10
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
`
`· ·· A.· · ·Okay.
`
`·3·
`
`· ·· Q.· · ·I'll turn this to 886 and 887.
`
`·4·
`
`
`
`· · · · · · MR. TUCKER:··Counsel, can I have a copy
`
`·5·
`
`· ·· as well?
`
`·6·
`
`
`
`· · · · · · MR. BERGER:··Sure, I have copies.
`
`·7·
`
`· ·· Q.· · ·It's in fact on 887, and I have copies.
`
`·8·
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`
`
`· · · · · · MR. BERGER:··I would like to mark as
`
`·9·
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`· ·· Exhibit 2 only the cover sheet, the copyright
`
`10·
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`· ·· sheet and certain pages that are attached
`
`11·
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`· ·· thereto.
`
`12·
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`
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`· · · · · · (Exhibit 2, Cover sheet entitled
`
`13·
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`· ·· "Stedman's Concise Medical Dictionary For The
`
`14·
`
`· ·· Health Professions, Illustrated/Third Edition"
`
`15·
`
`· ·· copyright date of 1997, with copyright sheet and
`
`16·
`
`· ·· certain pages, marked for identification, as of
`
`17·
`
`· ·· this date.)
`
`18·
`
`· ·· A.· · ·So we're looking at the definition of?
`
`19·
`
`· ·· Q.· · ·The definition of tissue.
`
`20·
`
`
`
`· · · · · · MR. TUCKER:··It's the last page right
`
`21·
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`· ·· here, 887.
`
`22·
`
`· ·· A.· · ·"A collection of similar cells and the
`
`23·
`
`·intercellular substances surrounding them."
`
`24·
`
`· ·· Q.· · ·Do you see any reference to layers there?
`
`25·
`
`· ·· A.· · ·Well, here, "there are four basic tissues
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`Page 11
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`·in the body; epithelium; the connective tissues,
`
`·3·
`
`·including blood, bone and cartilage; muscle tissue
`
`·4·
`
`·and nerve tissue."··So the cells and the substance
`
`·5·
`
`·surrounding them create layers.
`
`·6·
`
`· ·· Q.· · ·Would you say that epithelium would have
`
`·7·
`
`·layers?
`
`·8·
`
`· ·· A.· · ·Epithelium would have layers.
`
`·9·
`
`· ·· Q.· · ·And connective tissues would have layers?
`
`10·
`
`· ·· A.· · ·Connective tissue, actually they have
`
`11·
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`·layers between the different laws, because the
`
`12·
`
`·epithelium is constituted of cells and then there
`
`13·
`
`·is the submucosa, and then there is the advanticia.
`
`14·
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`·So basically there's epithelium, then there's
`
`15·
`
`·submucosa, there's a muscularis and there's
`
`16·
`
`·advanticia.··The connective tissue is typically
`
`17·
`
`·between the epithelium and the muscularis,
`
`18·
`
`·typically.
`
`19·
`
`· ·· Q.· · ·Is tissue ever just a layer without
`
`20·
`
`·multiple layers, is there ever tissue like that?
`
`21·
`
`· ·· A.· · ·If you consider epithelium itself to be
`
`22·
`
`·tissue, yes; but most tissue is constituted of many
`
`23·
`
`·layers.
`
`24·
`
`· ·· Q.· · ·But it doesn't have to be?
`
`25·
`
`· ·· A.· · ·It doesn't have to be.··It could be one
`
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`Page 12
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`·1·
`
`
`
`· · · · · · · · M. Kahaleh
`
`·2·
`
`·single layer.
`
`·3·
`
`· ·· Q.· · ·And it could be multiple layers?
`
`·4·
`
`· ·· A.· · ·It could be multiple layers.
`
`·5·
`
`· ·· Q.· · ·You may not know until you actually
`
`·6·
`
`·examine the tissue itself, isn't that correct?
`
`·7·
`
`· ·· A.· · ·Correct.··A bone is a tissue.
`
`·8·
`
`· ·· Q.· · ·I understand.··A second one of these
`
`·9·
`
`·dictionaries is Dorland's Illustrated Medical
`
`10·
`
`·Dictionary, Edition 28, copyright date is 1994.
`
`11·
`
`
`
`· · · · · · MR. BERGER:··This will be Exhibit 3.
`
`12·
`
`
`
`· · · · · · (Exhibit 3, Copy of pages from
`
`13·
`
`· ·· Dorland's Illustrated Medical Dictionary,
`
`14·
`
`· ·· Edition 28, copyright date 1994, marked for
`
`15·
`
`· ·· identification, as of this date.)
`
`16·
`
`· ·· Q.· · ·When we look at the page in Exhibit 3,
`
`17·
`
`·1714, that's the last one.
`
`18·
`
`· ·· A.· · ·Tissue.
`
`19·
`
`· ·· Q.· · ·Do you see the definition there of
`
`20·
`
`·tissue, "an aggregation of similarly specialized
`
`21·
`
`·cells united in the performance of a particular
`
`22·
`
`·function."··Is that an adequate description?
`
`23·
`
`· ·· A.· · ·Yes.
`
`24·
`
`· ·· Q.· · ·Does it require layers in that
`
`25·
`
`·definition?
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`Page 13
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`· ·· A.· · ·In that definition, no.
`
`·3·
`
`· ·· Q.· · ·This is called "Columbia University
`
`·4·
`
`·College of Physicians and Surgeons Complete Home
`
`·5·
`
`·Medical Guide Third Revised Edition."··The
`
`·6·
`
`·copyright date on that is 1995.
`
`·7·
`
`
`
`· · · · · · MR. BERGER:··So this will be Exhibit 4.
`
`·8·
`
`
`
`· · · · · · (Exhibit 4, Document entitled
`
`·9·
`
`· ·· "Columbia University College of Physicians
`
`10·
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`· ·· and Surgeons Complete Home Medical Guide
`
`11·
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`· ·· Third Revised Edition," copyright date 1995,
`
`12·
`
`· ·· marked for identification, as of this date.)
`
`13·
`
`· ·· Q.· · ·In Exhibit 4 Doctor -- I apologize, I'm
`
`14·
`
`·missing tissue in this.··We'll get to Exhibit 4
`
`15·
`
`·later then.
`
`16·
`
`· ·· A.· · ·Yes, sir.
`
`17·
`
`· ·· Q.· · ·We didn't use 4 for the moment, we'll
`
`18·
`
`·come back to it later.··The specimen that you
`
`19·
`
`·obtained with let's say the CDx, the U.S. Endoscopy
`
`20·
`
`·brushes, can you describe what that specimen is?
`
`21·
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`· ·· A.· · ·It's --
`
`22·
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`
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`· · · · · · MR. TUCKER:··I'm going to object again,
`
`23·
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`· ·· this is beyond the scope of his declaration;
`
`24·
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`· ·· go ahead and answer.
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`25·
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`· ·· A.· · ·It's what we call a brushing.··So you
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`Page 14
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·basically brush the epithelium, make contact with
`
`·3·
`
`·the brush and you bring it out.··It's a technique
`
`·4·
`
`·called protected brushing.··So the brush is inside
`
`·5·
`
`·the catheter, it comes out at the level of the
`
`·6·
`
`·tissue that you want to brush and then you brush
`
`·7·
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`·it, and then you put it back inside the catheter
`
`·8·
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`·and you pull it out.
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`·9·
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`
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`· · · · · · It's protected because when it's
`
`10·
`
`·traveling inside the scope it's within the
`
`11·
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`·catheter.··When it's outside the scope in contact
`
`12·
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`·with the tissue to be brushed, it's outside the
`
`13·
`
`·catheter.
`
`14·
`
`· ·· Q.· · ·What is the specimen like, is it a thin
`
`15·
`
`·specimen, a thick specimen, do you know?
`
`16·
`
`· ·· A.· · ·It's typically pretty thin in my
`
`17·
`
`·experience.
`
`18·
`
`· ·· Q.· · ·Are you able to observe what the specimen
`
`19·
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`·contains with your eye?
`
`20·
`
`· ·· A.· · ·No.
`
`21·
`
`· ·· Q.· · ·So how do you know what the specimen
`
`22·
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`·contains?
`
`23·
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`· ·· A.· · ·It looked like there's something on it,
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`24·
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`·but you're unable to say exactly what you have on
`
`25·
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`·it.
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`· ·· Q.· · ·Do you then need the pathologist to tell
`
`Page 15
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`·3·
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`·you?
`
`·4·
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`· ·· A.· · ·Yes.
`
`·5·
`
`· ·· Q.· · ·So is it correct that it's the
`
`·6·
`
`·pathologist who identifies the specimen material
`
`·7·
`
`·you've retrieved, is that correct?
`
`·8·
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`· ·· A.· · ·Correct.
`
`·9·
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`· ·· Q.· · ·And until the pathologist provides you
`
`10·
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`·with such a report, is it correct that you do not
`
`11·
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`·know what you've obtained, is that correct?
`
`12·
`
`· ·· A.· · ·Correct.··We know it's something, but we
`
`13·
`
`·don't know what it is.
`
`14·
`
`· ·· Q.· · ·Do you sometimes take specimens in your
`
`15·
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`·GI practice that do not have all the material you
`
`16·
`
`·want?
`
`17·
`
`· ·· A.· · ·I mean yeah, it happens, but the problem
`
`18·
`
`·is you never know that at the time.
`
`19·
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`· ·· Q.· · ·So sometimes you get everything you
`
`20·
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`·expect and sometimes you don't, is that correct?
`
`21·
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`· ·· A.· · ·Correct.
`
`22·
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`· ·· Q.· · ·Do you refer to the procedure as a biopsy
`
`23·
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`·even if you don't get everything?
`
`24·
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`· ·· A.· · ·I refer to it as a brushing.
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`25·
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`· ·· Q.· · ·A brushing.··You don't call the procedure
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`Page 16
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·a brush biopsy then?
`
`·3·
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`· ·· A.· · ·No, we call them brushing.
`
`·4·
`
`· ·· Q.· · ·So when you defined the word biopsy in
`
`·5·
`
`·your declaration you were referring to a brush,
`
`·6·
`
`·weren't you, in the patent that was involved?
`
`·7·
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`
`
`· · · · · · MR. TUCKER:··Do you need your
`
`·8·
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`· ·· declaration, if you're going to ask him
`
`·9·
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`· ·· questions about the dec.
`
`10·
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`· ·· Q.· · ·You defined the word biopsy in your
`
`11·
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`·declaration, correct?
`
`12·
`
`· ·· A.· · ·I defined the word biopsy but we're
`
`13·
`
`·talking here different, we're talking about the
`
`14·
`
`·procedure.··The procedure itself to do a biopsy is
`
`15·
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`·done, the biopsy is done with the biopsy forceps.
`
`16·
`
`· ·· Q.· · ·What does the biopsy forceps retrieve?
`
`17·
`
`· ·· A.· · ·It's supposed to retrieve the mucosa and
`
`18·
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`·submucosa.
`
`19·
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`· ·· Q.· · ·Does it retrieve the architecture intact
`
`20·
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`·as well?
`
`21·
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`· ·· A.· · ·As much as it can be preserved, yes.
`
`22·
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`· ·· Q.· · ·In a brush do you preserve the same type
`
`23·
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`·of architecture?
`
`24·
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`· ·· A.· · ·No, you don't.
`
`25·
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`· ·· Q.· · ·Yet, I think you said you don't use the
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`Page 17
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·word biopsy when you talk about the brushing, is
`
`·3·
`
`·that correct?
`
`·4·
`
`· ·· A.· · ·I separate the two procedures, even
`
`·5·
`
`·though the intent of brushing is to get the same
`
`·6·
`
`·tissue layers than the biopsy, it's still two
`
`·7·
`
`·different procedures.
`
`·8·
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`· ·· Q.· · ·So that when you use the brush you're
`
`·9·
`
`·really not doing a biopsy, is that your opinion?
`
`10·
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`· ·· A.· · ·Right.
`
`11·
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`· ·· Q.· · ·When you do a forceps biopsy I gather
`
`12·
`
`·that's lacerational, correct; you cut?
`
`13·
`
`· ·· A.· · ·Yeah.··I mean there's cutting involved
`
`14·
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`·because you're removing a piece of tissue.
`
`15·
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`· ·· Q.· · ·Let me just stop a second.
`
`16·
`
`
`
`· · · · · · Would it be fair to say that when you
`
`17·
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`·think of a layer cake, a birthday layer cake, that
`
`18·
`
`·a forceps biopsy is like cutting a whole piece out
`
`19·
`
`·intact, whereas a brush is like mixing all the
`
`20·
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`·material together.
`
`21·
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`
`
`· · · · · · Is that a fair distinction between how
`
`22·
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`·you retrieve the specimens?
`
`23·
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`· ·· A.· · ·It is a fair description.
`
`24·
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`· ·· Q.· · ·So that when you do the forceps biopsy
`
`25·
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`·you're trying to remove all the tissue intact,
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·including the layers and the architecture, correct?
`
`·3·
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`· ·· A.· · ·Correct.
`
`·4·
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`· ·· Q.· · ·But when you do a brushing that is not
`
`·5·
`
`·what you obtain, correct?
`
`·6·
`
`· ·· A.· · ·No, because you're disrupting the tissue.
`
`·7·
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`· ·· Q.· · ·Do you know what the significance is in
`
`·8·
`
`·retrieving the architectural integrity of a forceps
`
`·9·
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`·biopsy to the pathologist?
`
`10·
`
`· ·· A.· · ·The medusa is two different specimens.
`
`11·
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`·One is basically mixed cells and the other one is
`
`12·
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`·layer.
`
`13·
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`· ·· Q.· · ·You're applying the word biopsy to
`
`14·
`
`·layers, correct?
`
`15·
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`· ·· A.· · ·Correct.
`
`16·
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`· ·· Q.· · ·You would not apply the term biopsy to
`
`17·
`
`·mixed cells, is that correct?
`
`18·
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`· ·· A.· · ·Correct.
`
`19·
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`· ·· Q.· · ·The U.S. Endoscopy is brushing, correct?
`
`20·
`
`· ·· A.· · ·Yes.
`
`21·
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`· ·· Q.· · ·So you would not apply the term biopsy to
`
`22·
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`·the U.S. Endoscopy brush, is that correct?
`
`23·
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`· ·· A.· · ·That's correct.
`
`24·
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`· ·· Q.· · ·That would be true for CDx.··You would
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`25·
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`·not use the term biopsy as applied to the CDx
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`Page 19
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·brush, is that correct?
`
`·3·
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`· ·· A.· · ·That is correct.
`
`·4·
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`· ·· Q.· · ·To your knowledge, is one of the purposes
`
`·5·
`
`·of doing the brushing as opposed to a forceps
`
`·6·
`
`·biopsy to reduce potential injury to the patient?
`
`·7·
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`· ·· A.· · ·I wouldn't say that.
`
`·8·
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`· ·· Q.· · ·Are there some instances in which you
`
`·9·
`
`·would not want to do a lacerational biopsy into the
`
`10·
`
`·submucosa on a patient?
`
`11·
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`· ·· A.· · ·No.··I mean, they both can then create,
`
`12·
`
`·you know, enough trauma and create bleeding.
`
`13·
`
`· ·· Q.· · ·If you think about a biliary duct, if you
`
`14·
`
`·use a forceps biopsy there do you have danger of
`
`15·
`
`·the bile --
`
`16·
`
`· ·· A.· · ·You can --
`
`17·
`
`· ·· Q.· · ·Wait.··Would there be danger that the
`
`18·
`
`·bile might actually leave the duct and spread into
`
`19·
`
`·the patient's body in a forceps biopsy?
`
`20·
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`· ·· A.· · ·No.··I'm worried about bleeding, and if I
`
`21·
`
`·vigorously brush I'm also going to have bleeding,
`
`22·
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`·so I think both can lead to bleeding.
`
`23·
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`· ·· Q.· · ·So would it be fair to say you do not
`
`24·
`
`·think a forceps biopsy is more dangerous let's say
`
`25·
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`·in a glandular epithelium tissue than brushing, is
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·that correct?
`
`·3·
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`· ·· A.· · ·I think they're both as dangerous.
`
`·4·
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`· ·· Q.· · ·If you puncture the biliary duct in a
`
`·5·
`
`·forceps biopsy will the bile leave the duct?
`
`·6·
`
`· ·· A.· · ·First of all you don't puncture, you
`
`·7·
`
`·sample.
`
`·8·
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`· ·· Q.· · ·But you sample by cutting, right?
`
`·9·
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`· ·· A.· · ·You extract.
`
`10·
`
`· ·· Q.· · ·You grab it, is that it?
`
`11·
`
`· ·· A.· · ·That's an extraction.
`
`12·
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`· ·· Q.· · ·So you cut it?
`
`13·
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`· ·· A.· · ·You don't cut it, cutting would be to
`
`14·
`
`·slice something with a knife, that's cutting. We
`
`15·
`
`·extract it, the biopsy forceps extracts.
`
`16·
`
`· ·· Q.· · ·So a forceps biopsy in the biliary duct
`
`17·
`
`·doesn't cut, it extracts and pulls the tissue, is
`
`18·
`
`·that correct?
`
`19·
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`· ·· A.· · ·Correct.
`
`20·
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`· ·· Q.· · ·And I guess it tries to do so to keep the
`
`21·
`
`·architecture intact, correct?
`
`22·
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`· ·· A.· · ·Correct.
`
`23·
`
`· ·· Q.· · ·Do you know if in the 1980s forceps
`
`24·
`
`·biopsies did more cutting than the forceps biopsy
`
`25·
`
`·you just described?
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`Page 21
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`· ·· A.· · ·I think the forceps biopsy technology
`
`·3·
`
`·hasn't changed much, it just became smaller, that's
`
`·4·
`
`·it, to go in an area that we couldn't go.
`
`·5·
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`· ·· Q.· · ·Are you saying the instruments became
`
`·6·
`
`·smaller?
`
`·7·
`
`· ·· A.· · ·Yes.··The biopsy of the upper GI tract
`
`·8·
`
`·and biopsy of the bile duct are the same basically,
`
`·9·
`
`·the same conception.
`
`10·
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`· ·· Q.· · ·Does it matter the type of epithelium
`
`11·
`
`·you're dealing with, whether it's squamous or
`
`12·
`
`·glandular; does it matter?
`
`13·
`
`· ·· A.· · ·It doesn't matter, the only thing that
`
`14·
`
`·matters is the size.··You have to find the correct
`
`15·
`
`·biopsy size for the current epithelium that you are
`
`16·
`
`·targeting.
`
`17·
`
`· ·· Q.· · ·You're saying they would need the current
`
`18·
`
`·size of the forceps biopsy instrument you're
`
`19·
`
`·talking about?
`
`20·
`
`· ·· A.· · ·Correct.
`
`21·
`
`· ·· Q.· · ·That's interesting.··I think I asked this
`
`22·
`
`·question before, but I'm not sure.
`
`23·
`
`
`
`· · · · · · If you do a forceps biopsy and you don't
`
`24·
`
`·extract everything you intended to extract, do you
`
`25·
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`·still call it a biopsy?
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`Page 22
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`· ·· A.· · ·Yes.
`
`·3·
`
`· ·· Q.· · ·So whether or not you obtain all of the
`
`·4·
`
`·specimen material you intended you still call that
`
`·5·
`
`·procedure a biopsy, correct?
`
`·6·
`
`· ·· A.· · ·Correct.
`
`·7·
`
`· ·· Q.· · ·And you limit that solely to forceps
`
`·8·
`
`·biopsies, correct?
`
`·9·
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`· ·· A.· · ·Yes.
`
`10·
`
`· ·· Q.· · ·And that does not include the brush, the
`
`11·
`
`·brush technique you described, correct?
`
`12·
`
`· ·· A.· · ·I think if you're talking about biopsy,
`
`13·
`
`·you're talking about a forceps biopsy.
`
`14·
`
`· ·· Q.· · ·Okay.··Do you agree with this statement:
`
`15·
`
`
`
`· · · · · · "However, the use of a biopsy forceps
`
`16·
`
`·involves an inherent risk of perforating the duct
`
`17·
`
`·and for this reason their use is not preferred."
`
`18·
`
`
`
`· · · · · · Would you agree with that statement?
`
`19·
`
`· ·· A.· · ·I do not agree with that.
`
`20·
`
`· ·· Q.· · ·Why not?
`
`21·
`
`· ·· A.· · ·Because I've been biopsying bile duct
`
`22·
`
`·since 2001 and I never perforated a bile duct.
`
`23·
`
`· ·· Q.· · ·You never perforated the bile duct?
`
`24·
`
`· ·· A.· · ·With biopsy forceps, no.
`
`25·
`
`· ·· Q.· · ·One thing I was going to ask which you've
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`Page 23
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`·1·
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`· · · · · · · · M. Kahaleh
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`·2·
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`·answered yourself.··You are a very well qualified
`
`·3·
`
`·GI doctor.
`
`·4·
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`· ·· A.· · ·Thank you.
`
`·5·
`
`· ·· Q.· · ·Apparently from your writings, but some
`
`·6·
`
`·GI doctors might actually perforate a bile duct in
`
`·7·
`
`·a forceps biopsy, isn't that correct?
`
`·8·
`
`· ·· A.· · ·Yes, but that means they shouldn't be
`
`·9·
`
`·doing those procedures.
`
`10·
`
`· ·· Q.· · ·We understand, but sometimes the brush
`
`11·
`
`·might be less dangerous for those type of doctors,
`
`12·
`
`·isn't that correct?
`
`13·
`
`· ·· A.· · ·I'm not sure.··I think in the hands
`
`14·
`
`·of a biliary endoscopist who's well trained the
`
`15·
`
`·biopsy forceps is safe.
`
`16·
`
`· ·· Q.· · ·That's the best of all worlds, but we
`
`17·
`
`·don't live there.
`
`18·
`
`
`
`· · · · · · Are there doctors who might not be as
`
`19·
`
`·well trained for whom the brush would be safer to
`
`20·
`
`·use in obtaining a sample than a forceps biopsy?
`
`21·
`
`· ·· A.· · ·Yes.
`
`22·
`
`· ·· Q.· · ·But the sample the brush collects is
`
`23·
`
`·different than from the sample that the forceps
`
`24·
`
`·biopsy collects?
`
`25·
`
`· ·· A.· · ·Yes, brushing gives you a different
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`Page 24
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`·1·
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`
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`· · · · · · · · M. Kahaleh
`
`·2·
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`·sample than biopsy forceps.
`
`·3·
`
`· ·· Q.· · ·Let me read this to you.··Parasher,
`
`·4·
`
`·that's the name of the patent, he was the inventor,
`
`·5·
`
`·"Parasher recognized that these prior lacerational
`
`·6·
`
`·procedures run the risk of perforating the ducts,"
`
`·7·
`
`·is that correct?
`
`·8·
`
`
`
`· · · · · · MR. TUCKER:··Objection, this is beyond
`
`·9·
`
`· ·· the scope of his direct testimony and it's
`
`10·
`
`· ·· also an incomplete hypothetical.
`
`11·
`
`· ·· Q.· · ·I'll ask you again.
`
`12·
`
`
`
`· · · · · · Do you agree with this statement,
`
`13·
`
`·"Parasher recognized that these prior lacerational
`
`14·
`
`·procedures run the risk of perforating the duct,"
`
`15·
`
`·is that correct?
`
`16·
`
`
`
`· · · · · · MR. TUCKER:··Same objection.
`
`17·
`
`· ·· A.· · ·Which laceration procedure are we talking
`
`18·
`
`·about here?
`
`19·
`
`· ·· Q.· · ·We are a talking about forceps biopsy,
`
`20·
`
`·that's what we just said before.
`
`21·
`
`· ·· A.· · ·Yes, there's a chance of perforation in
`
`22·
`
`·the hands of people that are not well trained, yes.
`
`23·
`
`· ·· Q.· · ·The device of Parasher, which is a brush;
`
`24·
`
`·I'm representing to you the device of Parasher is a
`
`25·
`
`·brush, permits the user to obtain the same biopsy
`
`REPORTERS CENTRAL, LLC * 212-594-3582
`
`

`
`Page 25
`
`·1·
`
`
`
`· · · · · · · · M. Kahaleh
`
`·2·
`
`·tissue samples as those forceps biopsy?
`
`·3·
`
`
`
`· · · · · · MR. TUCKER:··Same objection.
`
`·4·
`
`· ·· Q.· · ·Is that statement correct or incorrect?
`
`·5·
`
`
`
`· · · · · · MR. TUCKER:··Same objection.
`
`·6·
`
`· ·· A.· · ·That's a hypothesis.
`
`·7·
`
`· ·· Q.· · ·You said before you end up with different
`
`·8·
`
`·samples?
`
`·9·
`
`· ·· A.· · ·Yes.
`
`10·
`
`· ·· Q.· · ·So that statement that says it's the same
`
`11·
`
`·biopsy tissue sample, that is not correct?
`
`12·
`
`
`
`· · · · · · MR. TUCKER:··Objection.
`
`13·
`
`· ·· A.· · ·That is not correct.
`
`14·
`
`· ·· Q.· · ·Dr. Kahaleh, I show you the next exhibit
`
`15·
`
`·which will be Exhibit 5, this is your declaration.
`
`16·
`
`
`
`· · · · · · (Exhibit 5, Declaration of Michael
`
`17·
`
`· ·· Kahaleh, marked for identification, as of
`
`18·
`
`· ·· this date.)
`
`19·
`
`· ·· Q.· · ·By the way, before today do you have any
`
`20·
`
`·idea how much time you spent on this project?
`
`21·
`
`· ·· A.· · ·Between 1 hour and a half to 2 hours
`
`22·
`
`·total, between discussion and reading, yeah.
`
`23·
`
`· ·· Q.· · ·Would you look at paragraph 10?
`
`24·
`
`· ·· A.· · ·Yes.
`
`25·
`
`· ·· Q.· · ·The third line down says "In my
`
`REPORTERS CENTRAL, LLC * 212-594-3582
`
`

`
`Page 26
`
`·1·
`
`
`
`· · · · · · · · M. Kahaleh
`
`·2·
`
`·experience, a biopsy is an examination..."
`
`·3·
`
`
`
`· · · · · · Does the use of the word biopsy there
`
`·4·
`
`·mean that it is directed to the forceps biopsy, in
`
`·5·
`
`·your mind?
`
`·6·
`
`· ·· A.· · ·Yes.
`
`·7·
`
`· ·· Q.· · ·A little further down you have,
`
`·8·
`
`·"Additionally, when a biopsy is performed a doctor
`
`·9·
`
`·understands and expects...", do you see that line?
`
`10·
`
`· ·· A.· · ·Which one?
`
`11·
`
`· ·· Q.· · ·It's in the middle, "Additionally, when a
`
`12·
`
`·biopsy is performed a doctor understands and
`
`13·
`
`·expects...".
`
`14·
`
`· ·· A.· · ·Yes.
`
`15·
`
`· ·· Q.· · ·In that case again you were referring to
`
`16·
`
`·the forceps biopsy, correct?
`
`17·
`
`· ·· A.· · ·Correct.
`
`18·
`
`· ·· Q.· · ·When you say the "doctor understands and
`
`19·
`
`·expects" that really depends on his skill.··You
`
`20·
`
`·might understand and expect that, but someone less
`
`21·
`
`·trained than you might not get that the biopsy
`
`22·
`
`·sample would include fragments of epithelium and
`
`23·
`
`·fragments of submucosa, isn't that correct?
`
`24·
`
`· ·· A.· · ·Correct.
`
`25·
`
`· ·· Q.· · ·Someone less trained than you.··But that
`
`REPORTERS CENTRAL, LLC * 212-594-3582
`
`

`
`Page 27
`
`·1·
`
`
`
`· · · · · · · · M. Kahaleh
`
`·2·
`
`·person would still be performing a biopsy, correct?
`
`·3·
`
`· ·· A.· · ·Correct.
`
`·4·
`
`
`
`· · · · · · MR. BERGER:··Let's take 2 minutes.
`
`·5·
`
`
`
`· · · · · · (Short recess taken.)
`
`·6·
`
`·EXAMINATION BY
`
`·7·
`
`·MR. TUCKER:
`
`·8·
`
`· ·· Q.· · ·In your career, approximately how many
`
`·9·
`
`·procedures have you performed using the biliary
`
`10·
`
`·brush?
`
`11·
`
`· ·· A.· · ·Between 3 to 5,000.
`
`12·
`
`· ·· Q.· · ·3 to 5,000.··In your opinion, if a
`
`13·
`
`·biliary brush causes bleeding does that mean it is
`
`14·
`
`·a lacerational brush?
`
`15·
`
`· ·· A.· · ·Yes.··If you apply enough force any brush
`
`16·
`
`·can cause a laceration.
`
`17·
`
`· ·· Q.· · ·When you perform a biopsy versus what you
`
`18·
`
`·called today a brushing, would you agree that you
`
`19·
`
`·get the same sample of cells in each procedure?
`
`20·
`
`· ·· A.· · ·You get the same sample of cell, it isn't
`
`21·
`
`·in the same form.
`
`22·
`
`· ··

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