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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` --------------------
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` IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
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` --------------------
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` PRAXAIR DISTRIBUTION, INC.
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` Petitioner
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` vs.
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` INO THERAPEUTICS, LLC, d/b/a IKARIA, INC.
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` Patent Owner
`
` --------------------
`
` CASE IPR 2015-00884
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` CASE IPR 2015-00888
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` CASE IPR 2015-00889
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` CASE IPR 2015-00891
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` CASE IPR 2015-00893
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` VIDEOTAPED DEPOSITION OF EXPERT WITNESS
`
` ROBERT T. STONE, Ph.D.
`
` Menlo Park, California
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` Wednesday, December 2, 2015
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`Reported by:
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`ANA M. DUB, RMR, CRR, CCRR
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`CSR No. 7445
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` --------------------
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` IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
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` --------------------
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` PRAXAIR DISTRIBUTION, INC.
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` Petitioner
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` vs.
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` INO THERAPEUTICS, LLC, d/b/a IKARIA, INC.
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` Patent Owner
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` --------------------
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` CASE IPR 2015-00884
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` CASE IPR 2015-00888
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` CASE IPR 2015-00889
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` CASE IPR 2015-00891
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` CASE IPR 2015-00893
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` VIDEOTAPED DEPOSITION OF EXPERT WITNESS
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` ROBERT T. STONE, Ph.D.
`
` Menlo Park, California
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` Wednesday, December 2, 2015
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`Reported by:
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`ANA M. DUB, RMR, CRR, CCRR
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`CSR No. 7445
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` --------------------
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` IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
` --------------------
`
` PRAXAIR DISTRIBUTION, INC.
`
` Petitioner
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` vs.
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` INO THERAPEUTICS, LLC, d/b/a IKARIA, INC.
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` Patent Owner
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` --------------------
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` CASE IPR 2015-00884
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` CASE IPR 2015-00888
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` CASE IPR 2015-00889
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` CASE IPR 2015-00891
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` CASE IPR 2015-00893
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` Deposition of ROBERT T. STONE, Ph.D., taken on
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`behalf of Patent Owner INO Therapeutics, LLC, d/b/a
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`Ikaria, Inc., at the Law Offices of Latham &
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`Watkins, 140 Scott Drive, Menlo Park, California,
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`beginning at 9:05 a.m. and ending at 3:02 p.m. on
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`Wednesday, December 2, 2015, before Ana M. Dub, RMR,
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`CRR, CCRR, Certified Shorthand Reporter No. 7445.
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
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`Ex. 2020-0002
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`
`
`A P P E A R A N C E S :
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`Page 3
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`F o r P e t i t i o n e r P r a x a i r D i s t r i b u t i o n , I n c . :
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` K & L G A T E S
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` B Y : B E N J A M I N E . W E E D
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` A t t o r n e y A t L a w
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` 7 0 W e s t M a d i s o n S t r e e t , S u i t e 3 1 0 0
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` C h i c a g o , I l l i n o i s 6 0 6 0 2 - 4 2 0 7
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` 3 1 2 . 7 8 1 . 7 1 6 6
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` b e n j a m i n . w e e d @ k l g a t e s . c o m
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`F o r P a t e n t O w n e r I N O T h e r a p e u t i c s , L L C , d / b / a
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`I k a r i a , I n c . :
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` L A T H A M & W A T K I N S L L P
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` B Y : D A V I D K . C A L L A H A N
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` A t t o r n e y A t L a w
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`Ex. 2020-0003
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`APPEARANCES (Cont.):
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`Page 4
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`For Patent Owner INO Therapeutics, LLC, d/b/a
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`Ikaria, Inc.:
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` LATHAM & WATKINS LLP
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` BY: ANDREW J. FOSSUM
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` Attorney At Law
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` 811 Main Street, Suite 3700
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` Houston, Texas 77002
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` 713.546.7449
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` andrew.fossum@lw.com
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`ALSO PRESENT:
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` Kenneth D. Goetz, Mallinckrodt Pharmaceuticals
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` Keith Stephens, Videographer
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`Ex. 2020-0004
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`Page 5
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` INDEX
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`WITNESS EXAMINATION
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`ROBERT T. STONE, Ph.D.
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` BY MR. CALLAHAN 7
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` AFTERNOON SESSION 137
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` BY MR. CALLAHAN (Resumed) 137
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` BY MR. WEED 175
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`Number Description Page
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`Exhibit 2016 United States Patent 168
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` No. 5,913,309
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`Exhibit 2017 Color Copy of English 158
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` Translation of Exhibit
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` 1011
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`Exhibit 2018 Color Copy Blowup of Flip 158
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` Side of Brochure
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`Exhibit 2019 Color Copy of Photographs 174
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` of Praxair Nitric Oxide
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` Delivery System NoMix
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`Ex. 2020-0005
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`Page 6
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` Menlo Park, California
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` Wednesday, December 2, 2015
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` 9:05 a.m.
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` P R O C E E D I N G S
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` THE VIDEOGRAPHER: Good morning.
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` We are going on the record. The time is
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`9:05 a.m. on today's date, December 2nd, 2015. This
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`is the video-recorded deposition of Dr. Robert
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`Stone.
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` My name is Keith Stephens, here with our
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`court reporter, Ana Dub. We are here from Veritext
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`Legal Solutions at the request of the defendant.
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` This deposition is being held at Latham &
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`Watkins in Menlo Park, California.
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` And the caption of the case is
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`Praxair Distribution, Inc. versus INO Therapeutics,
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`Inc., and the case numbers are IPR 2015-00884, IPR
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`2015-00888, IPR 2015-00889, IPR 2015-00891, and IPR
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`2015-00893.
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` Will counsel please identify yourselves
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`and state whom you represent.
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` MR. CALLAHAN: David Callahan. I am here
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`on behalf of INO Therapeutics. With me is Andrew
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`Fossum of Latham & Watkins and Ken Goetz, G-o-e-t-z,
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`of Mallinckrodt.
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`Ex. 2020-0006
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`Page 7
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` MR. WEED: And Benjamin Weed from
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`K&L Gates on behalf of the petitioner, Praxair, and
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`the witness.
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` THE VIDEOGRAPHER: Thank you.
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` And the witness may now be sworn in.
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` ROBERT T. STONE, Ph.D.,
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`having been administered an oath, was examined and
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`testified as follows:
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` EXAMINATION
`
`BY MR. CALLAHAN:
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` Q Good morning, Dr. Stone. How are you?
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` A Fine. Thank you.
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` Q My name is David Callahan. As you've
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`heard, I'm from Latham & Watkins. We represent
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`INO Therapeutics, also known as Ikaria in this case.
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`I'll be taking your deposition today.
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` Have you given deposition testimony
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`before?
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` A I have.
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` Q So you're familiar with the sort of
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`general rules of taking -- or giving a deposition?
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` A Yes.
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` Q All right. I will ask you -- and I will
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`Ex. 2020-0007
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`Page 8
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`endeavor myself to not talk over you, for the
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`benefit of our court reporter, and I'd ask that you
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`do the same.
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` If I ask a question that you don't
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`understand, I take it you will let me know that. Is
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`that right?
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` A Yes.
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` Q And if -- I'm sorry. Let me just step
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`back.
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` Have you been retained as an expert in the
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`matters that the videographer referred to at the
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`outset, the various procedures of the Patent Office?
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` A Yes, I have.
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` Q When were you retained by Praxair?
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` A I was interviewed. I don't know the exact
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`date of the retention, but in August of last year.
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` Q August 2014?
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` A That's correct.
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` Q When did you begin your work for them?
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` A I seriously began the work in October of
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`2014.
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` Q And did you -- have you prepared a number
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`of declarations, one for each of the five
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`proceedings that were introduced at the outset of
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`the deposition?
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`Ex. 2020-0008
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`Page 9
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` A Yes.
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` Q Let's mark those. Actually, they're
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`already marked.
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` These are the docs?
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` Okay. Dr. Stone, I'm going to hand you
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`what we've marked as -- what has previously been
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`marked as Praxair 1002.
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` Okay. And then that is Exhibit 1002 in
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`the '209 IPR; correct?
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` A That's what it states here, yes.
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` Q Okay. Then I'm going to hand you what's
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`been marked already as Praxair 1002 in the '210 IPR
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`and 1002 in the '794 IPR, 1002 in the '795 IPR and
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`1002 in the '904 IPR.
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` And then, so you've got the corresponding
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`patents, Dr. Stone, I'm going to hand you what's
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`been marked as Praxair 1001 in the '209 case --
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`that's U.S. Patent 8,573,209 -- and what's been
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`marked as Praxair 1001 in the '210 case -- that's
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`U.S. Patent No. 8,573,210 -- what's been marked as
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`Praxair 1001 in the '794 case, which is U.S. Patent
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`8,776,794; what's been marked as Exhibit 1001 in the
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`'795 case -- that's U.S. Patent 8,776,795 -- and,
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`lastly, what's been marked as Exhibit 1001 in the
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`'904 case, which is U.S. Patent 8,291,904.
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`Ex. 2020-0009
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`Page 10
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` Okay. So you've got each of your five
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`declarations that you submitted in these five
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`matters and the corresponding patent in front of
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`you; is that correct?
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` A That's correct.
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` Q With respect to the declarations -- so the
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`documents that we have marked as 1002 in each of the
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`respective cases -- do those have all of the expert
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`opinions that you have reached in this matter to
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`date?
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` A To the best of my knowledge, yes.
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` Q Okay. Is there anything since -- is there
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`anything you've become aware of -- since you
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`prepared these declarations in March of this year,
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`is there anything you've become aware of that you
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`think further supports the opinions that are
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`contained in the various Exhibit 1002s?
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` A Nothing I can think of.
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` Q Okay. Is there anything that you've seen
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`in the time since you submitted these declarations
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`in March of 2015 that you think contradicts or calls
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`into question any of the opinions that you reached
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`that are contained in your declarations?
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` A No.
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` Q Do your declarations, the various
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`Ex. 2020-0010
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`Exhibit 1002s, do those disclose all of the
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`materials that you relied upon in reaching the
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`opinions that you express in the declarations?
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` A Outside materials, other than my own
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`personal knowledge and understanding, that's
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`correct.
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` Q Okay. So if I look at the declaration and
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`add to that your personal knowledge, that
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`constitutes the universe of materials on which you
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`relied in reaching your opinions in these matters;
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`is that correct?
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` A I believe that's correct.
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` Q How is it that you obtained the various
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`prior art materials and technical materials that are
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`referenced in your declarations?
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` A Some of the material was given to me by
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`the attorneys, and some of it I found on my own.
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` Q Okay. Can you recall for me which of the
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`materials that you reference in your declarations
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`you found on your own?
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` A Don't recall the patent number, but there
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`is a patent that has to do with respiratory gases
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`and the -- the necessity of preventing more than one
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`gas cylinder being used at a time. Very old patent,
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`requiring a lockout so that two different sources of
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`Ex. 2020-0011
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`gas could not be used simultaneously.
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` Q Did you come up with -- or did you
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`discover any other of the pieces of prior art or
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`technical materials that are referenced in your
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`declarations?
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` A I have to review, but I don't recall any
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`at this point.
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` Q Did you -- so the rest of the materials
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`would have been provided to you by counsel for
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`Praxair; is that correct?
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` A Excuse me. I think I need to correct.
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` I'm not sure whether counsel provided me
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`with or whether I knew of the infrared communication
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`standard.
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` Q Okay. So, again, excepting the infrared
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`standard and this patent that relates to respiratory
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`gases, preventing more than one gas from being used
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`simultaneously, did counsel for Praxair provide you
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`with the rest of the materials that formed the basis
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`for the opinions you reached in this case?
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` A I believe that's correct.
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` Q Did you ask counsel for Praxair for any
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`other materials, either specifically or
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`categorically, to consider in connection with the
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`preparation of your expert declarations?
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`Ex. 2020-0012
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`Page 13
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` A I do not recall doing so.
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` Q Is there -- as you sit here today, is
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`there anything that you feel that you would have
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`liked to have been able to look at or consider
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`before preparing your expert declarations in these
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`five matters?
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` A Only from the standpoint of the -- my
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`understanding of fluidics and whether they applied.
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`And I was asked to keep it restricted, in general,
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`to therapeutic gas delivery or gas delivery systems
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`as opposed to fluidics in general.
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` Q So you were interested in considering the
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`possible application of fluidics in this matter and
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`were told to keep it focused only on gases?
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` A On these patents, yes, that's correct.
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` Q And you were told that by counsel for
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`Praxair; is that right?
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` A I was told the others would probably not
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`be pertinent. That's correct.
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` Q Is there any information of any type that
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`Praxair or any of Praxair's counsel provided you
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`with that you relied on for your opinions that isn't
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`disclosed in your report?
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` A That I relied on for my opinions? No.
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` Q I've gone through your C.V., Dr. Stone,
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`Ex. 2020-0013
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`and am wondering whether you've had any experience
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`in the course of your career with FDA rules,
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`regulations, or processes relating to medical
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`devices.
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` A Yes.
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` Q I take it from the way you looked at me
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`when you answered that question that you've had a
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`pretty fair amount of experience with the FDA as it
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`pertains to medical devices. Is that right?
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` A That is correct.
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` Q Okay. Can you -- based on that
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`experience, can you just tell me, in your
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`understanding, what is -- in the FDA world, what's a
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`Class III medical device?
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` A Oh. If I don't reverse the orders.
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` Q I'll give you a hint on this one.
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` A I think --
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` Q III is the highest.
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` A Yeah. Okay. Class III medical devices
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`would relate to devices that certainly could be
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`directly implantable devices, things that could have
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`a severe adverse effect if they fail.
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` A large number of Class III devices that
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`I -- some of the Class III devices that I have
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`worked and/or supervised on have been implantable
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`valves. Reviewed defibrillators, things of that
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`nature. Just things that could have an immediate
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`and severe effect on a person.
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` Q And then what about Class II? We'll skip
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`Class I.
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` A Okay. A lot of the Class II devices --
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`for example, my first work was with a company called
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`Nellcor that did pulse oximeters, which can diagnose
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`hypoxia in a patient. It's probably now one of the
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`most ubiquitous medical devices that's out there.
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` Other Class II devices might be devices
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`for therapies where you could have some harm if they
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`failed but it's not likely to be severe and adverse
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`immediately.
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` Q In the art to which the patents that are
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`at issue in these proceedings pertain and the
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`devices that are disclosed in these patents, would
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`you consider those Class II or Class III --
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` MR. WEED: Objection to form and scope.
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`BY MR. CALLAHAN:
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` Q -- devices?
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` A I believe that for -- especially since it
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`was a PMA device as it originally went out, I think
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`that this is likely to be a Class III device.
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` Q And you mentioned "PMA." That was
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`actually one of the things I wanted to ask about.
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`What is "PMA"? What's your understanding of that,
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`based on your experience in this field?
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` A I'll have to ask if you want a long or a
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`short answer.
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` Q Give me the short one first. Then we'll
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`see.
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` A Okay. PMA, premarket approval, is for
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`devices for which there is no adequate predicate
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`device, not really sure what the -- what all the
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`outcomes are to be. It allows a great deal more
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`monitoring, a number of changes. Any change
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`requires a very careful review by the FDA before
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`it's allowed.
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` It's just a higher level of attention that
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`the FDA pays because there's not enough experience
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`with the device. It's not a pre-1976, or a device
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`that's had several 510(k)s, or several others have
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`been issued before the FDA will approve it.
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` Q Okay. And then so this is, somebody wants
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`to do something new in the medical device space,
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`sufficiently new that the FDA says: We better take
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`a real close look at this. Is that right?
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` A That's correct.
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` Q Okay. And then you mentioned 510(k).
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`What -- in your years of experience in this field,
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`what's the 510(k) process in the FDA world?
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` A Sure. For devices that are very similar
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`to devices that are on the market -- "substantially
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`equivalent" is the term that the FDA utilizes.
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` One can produce evidence to the FDA that a
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`new device is substantially equivalent to a prior
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`device. And the FDA has guidelines for helping
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`determine what "substantial equivalence" is. Then
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`the device can -- you can notify the FDA that it's
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`going to be marketed.
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` Provided enough information, the FDA can
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`determine whether, indeed, it is a substantially
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`equivalent device to either a pre-1976 or to a
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`device that's had multiple sources and multiple
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`approvals in the past.
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` Then the device can go through a less
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`rigorous process prior to marketing the device.
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` Q And have you, in your career, taken
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`medical devices through PMA approval, premarket
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`approval?
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` A I have worked on devices that went through
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`PMA. I did not direct the guidance through PMAs.
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` Q But you've worked on devices that were
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`going through PMAs?
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` A That's correct.
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` Q And is the same true with respect to
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`Page 18
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`510(k) approvals?
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` A Yes.
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` Q I take it in connection with --
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` A Sorry. It's more extensive than that.
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` And with regard to 510(k)s, I've actually
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`written them and sheltered them through --
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`shepherded them through. Sorry.
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` Q I take it, in connection with the 510(k)
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`approval process, then, you've taken a look at
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`predicate devices to determine whether and the
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`extent to which you could use those to support a
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`510(k) request?
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` A Yes.
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` Q And have also had experience determining
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`whether and the extent to which a product at issue
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`is a substantial equivalent to a predicate device?
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` A Yes.
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` Q All right. I just -- I take it from the
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`amount of experience you've had here, that this
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`regulatory approval scheme is a pretty
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`predominant -- or prominent, maybe I should say, in
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`the design and manufacture of medical devices.
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`Would you agree with that?
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` A Yes.
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` Q How, if at all, does the regulatory
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`scheme -- premarket approval, 510(k) approvals,
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`looking for predicate devices, et cetera -- how does
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`that affect, in your experience, the way that people
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`design medical devices?
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` A The actual design of the medical device
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`itself is regulated by the FDA in that a fully
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`documented process has to be incorporated from the
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`time the device begins the productization phase.
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` From the design standpoint, if one is
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`inventing in another field, one can simply come up
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`with a solution and start working on it and go to
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`town.
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` If one is trying to come up with a design
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`for something in the medical field, one needs to
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`look at what all the regulatory issues would be to
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`be sure that the device, as designed and as built,
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`is likely to be approved by the FDA.
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` Q So what does that entail? So if I'm
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`coming out with a medical device and I don't get the
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`opportunity, in your words, to just go to town as I
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`might if I were designing a computer or something
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`else, what are the constraints that the regulatory
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`environment places on you as a product designer?
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` A Me, as a product designer, typically, as I
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`begin the design process, I'll come up with a
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`definition of the problem, how I would like to solve
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`it. I will look to see whether there are predicate
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`devices and what process I'm likely to need to
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`follow. I might consult so-called regulatory
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`bodies, testing labs, and so forth, to find out what
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`their concepts are. Incorporate all of those issues
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`into the very beginning of the documentation process
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`before I would actually even begin the design.
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` I have a whole presentation that I do for
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`clients, when it comes to doing a medical product
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`design, to show that we can have an FDA-compliant
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`design process. But that's a half-hour
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`presentation.
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` Q But at the end of the day, you go into
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`this process making sure that you've got a
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`product -- or you're going to end up with a product
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`that is going to get regulatory approval; correct?
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` A Yes.
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` Q And in your experience, is what you just
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`described as your own personal experience, is that
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`the way that medical products are generally
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`designed?
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` A That's the way by law it should be
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`designed here in the United States. And there's a
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`similar process for Europe, for Canada, for Japan,
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`for China.
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` Q Do product designers in the medical device
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`field, do they use materials that have already been
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`filed with the FDA, or products that have already
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`been approved, as guidance to help them design
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`products that are safe and effective for use?
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` A In my experience, yes.
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` Q I want to go back to what you described as
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`the first step in your process, which is -- and if I
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`got this wrong, you should feel free to correct me
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`because I'm going from my chicken scratch notes
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`here.
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` But it sounded like the first step in your
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`process is determining what the problem is. Is that
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`right?
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` A That's correct.
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` Q Okay. How is it -- as a designer of
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`products in the medical device field, how is it that
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`you go about figuring out what the problem is that
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`you're looking to address?
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` A I can only answer that from a personal
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`standpoint.
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` I review a lot of medical literature,
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`publications describing what's happening in medicine
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`on a daily basis. I look at what the marketplace is
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`looking for, what are the problems that need to be
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`solved. And from reviewing the various
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`technologies, can I somehow take that technology,
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`modify it, and solve a problem that's out there.
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` I don't believe in finding a solution,
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`then going out and looking for a problem. I believe
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`in finding a problem, then looking for a solution.
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` Q And what do you -- when you're reviewing
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`the medical literature, as you described, reviewing
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`the marketplace information, can you give me some
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`examples of things that you see where you have the
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`"aha" moment of at least what the problem is that
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`needs to be solved?
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` A Best example would be a personal example
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`from years ago.
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` One of the problems with pulse oximetry is
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`that it was susceptible to motion artifact and
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`generated a lot of alarms in an area where it ought
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`to be quiet and the alarms weren't necessary. So I
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`looked at various signal processing techniques and
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`ended up filing patents that related to both the
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`accuracy and the -- helping to immunize the devices
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`against those alarms.
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` So finding out that there's a
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`problem: too much stimulus in a nursery. How do
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`we reduce that, and how -- by making the device work
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`better and solving the problem.
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` Q And so you would have found out about that
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`by reading literature that says: We've got this
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`nursery; these kids are supposed to be sleeping; and
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`one or more of the kids is alarming their pulse
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`oximeter every ten minutes and nobody can get any
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`sleep.
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` A In that particular instance, it was both
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`by looking at public data and actually visiting a
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`neonatal intensive care unit and confirming that
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`that was the case.
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` Q And is that -- in your experience, the way
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`that you identify problems, is that consonant with
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`the way you see, or have seen in your career, other
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`designers of medical devices figuring out their
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`start point or figuring out what the problem is?
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` A That's one of the ways. Another way is
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`clinicians who come to us with an idea. They found
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`a problem, and they would like a solution.
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` Q Any other ways that you go about this
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`first step of identifying what the problem is?
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` A I can't tell you all the things that
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`trigger the "aha." Sometimes it's simply reading
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`something and noting; noting that it might apply
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`from one field to another.
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` The inventive process typically is finding
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`out what the problems are and then, hopefully,
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`you'll have a mind that has a broad enough funnel
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`that, as things come into it, you'll see how those
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`might apply and how it might be modified.
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` Q Okay. What sources are you aware of for
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`people in your field, designers of medical devices,
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`what sources are available to you folks to identify,
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`let's start with, safety issues with medical
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`devices?
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` A Oh, I believe there's AAMI, the American
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`Association of Medical Instruments, some of their
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`guidelines and publications that they have with
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`regard to safety. They have conferences.
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` I attend such conferences and medical
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`device conferences, seeing what's on. I haven't for
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`a while, but certainly used to attend the American
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`Society of Anesthesiology, and looking at their
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`publications. All kinds of sources of that nature.
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` Q Are there any -- besides going to
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`conferences or looking at these publications, any
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`other sources for designers of medical devices to
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`identify existing and maybe unmet problems with
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`medical devices?
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` A There's a lot of publications and a lot of
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`online publications. I personally get about a dozen
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`each day that I look through to look at what the
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`problems are, what the potential -- what new
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`solutions there might be, how a solution might be
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`applied to one particular medical problem and I know
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`of another.
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` And, frankly, I know a number of
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`clinicians, including two that are on my board of
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`directors, and a son, who is not, who's a clinician,
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`that I can discuss those and potential solutions
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`with.
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` I think that typically, an engineer, a
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`designer, would want to have access to that kind of
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`information before beginning the process.
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` Q Would or would not?
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` A Would.
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` Q Okay.
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` A Yes.
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` Q Yeah. You'd want to have some -- as you
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`said, you're not looking for solutions to problems
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`that don't exist; right? You're looking for
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`problems and then trying to figure out solutions to
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`them; right?
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` A That's correct.
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` Q So I'm just trying to figure out in a
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`little more detail what the source material can be
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`for the problems.
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` Does the FDA have any available data,
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`information, anything like that, to help you learn
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`about existing problems with medical devices?
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` A The FDA has a database of failures that
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`have been reported with regard to devices. I don't
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`know about lists of other, what I refer to as,
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`clinical problems.
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` Q And what is that -- what is the FDA
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`database to which you're referring?
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` A It's referred to as the MAUDE database.
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` Q So you could look -- a product designer
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`could look for the particular product or products in
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`which they're interested and see what kinds of
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`device failures are reported up into the MAUDE
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`database and use that as a source for figuring out
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`if there's a problem to be addressed; is that right?
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` A That's a possibility. I personally doubt
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`that that would be as efficacious as some of the
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`broad-based problems that are out there.
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` Q So you're really looking for the people --
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`to use an expression -- who have got their feet on
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`the ground dealing with patients, to be reporting
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`these kinds of issues or problems or challenges that
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`they're having. Is that fair?
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` A Very much so.
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` Q Okay. Let me ask -- let me turn the page
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`a little bit, both literally here and figuratively,
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`and ask about your experience with gases generally.
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` I know you covered some of this in your
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`report, and there's some things mentioned in your
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`C.V. But give me an overview of what your
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`experience is with different gases that are used in
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`the medical field.
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` A First direct experience was with
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`anesthesia machines which delivered oxygen and
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`anesthetic gases.
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` Various types of anesthetic circuits.
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`Took one and modified it to drive a tonometer that I
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`had designed in my early work at Nellcor in order to
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`adjust blood oxygen levels to different levels for
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`testing out measurements.
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` Helped develop carbon dioxide sensors that
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`would be utilized in such environments for measuring
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`end-tidal CO2 more conveniently and more readily.
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` Attempting to solve problems in the
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
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`Ex. 2020-0027
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`Page 28
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`positioning of trach tubes, which an infrequent but
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`very damaging circumstances where the esophagus is
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