Date: April 15, 2019
`
`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL
`
`INFORMATION
`
`Internet: www.acefederal.com
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`
`Email: info@acefederal.com
`
`Bracco EX. 2006
`
`Jubilant V. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2006
`Jubilant v. Bracco
`IPR2018-01449
`
`
`
`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL
`
`INFORMATION
`
`Internet: www.acefederal.com
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`
`Email: info@acefederal.com
`
`Bracco EX. 2006
`
`Jubilant V. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2006
`Jubilant v. Bracco
`IPR2018-01449
`
`
`
`INTERNATIONAL TRADE COMMISSION
`
`__________________ X
`
`IN THE MATTER OF:
`
`Investigation Number
`
`CERTAIN STRONTIUM—RUBIDIUM
`
`: 337-TA—1110
`
`RADIOISOTOPE INFUSION SYSTEMS AND
`
`
`
`COMPONENTS THEREOF INCLUDING
`
`GENERATORS
`
`__________________ X
`
`HEARING - VOLUME III
`
`April 15, 2019
`
`Courtroom C
`
`U.S. International Trade
`
`Commission
`
`500 E Street,r S.W.
`
`Washington, D.C.
`
`The Hearing commenced, pursuant
`
`to notice of the
`
`Judge,
`
`at
`
`9:01 a.m., before the Honorable CLARK S. CHENEY,
`
`Administrative Law Judge for the United States
`
`International Trade Commission.
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`Ace-Federal Reporters,
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`Inc.
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`2O
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`21
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`22
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`23
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`24
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`25
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`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`is Bob Hails.
`
`I'm not sure we've been introduced on
`
`Page 581
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`Thursday, but just for the record.
`
`We are going to call
`
`Dr. Robert Stone to the stand.
`
`Can we have two minutes to check out the AV
`
`hookup and make sure everything is up and running.
`
`JUDGE CHENEY: Yes. Let's go off the record for
`
`two minutes.
`
`{Recess.)
`
`JUDGE CHENEY: Let's go back on the public
`
`Dr. Stone, please stand, raise your right hand
`
`and I‘ll swear you in.
`
`Whereupon,
`
`ROBERT THOMAS STONE,
`
`was called as a witness, and having been duly sworn, was
`
`examined and testified as follows:
`
`MR. HAILS:
`
`Thank you, Your Honor.
`
`DIRECT EXAMINATION
`
`BY MR. HAILS:
`
`Q
`
`Good afternoon, Dr. Stone. Would you introduce
`
`yourself to the Court give them your name and tell them
`
`And what does your company do?
`
`where you work.
`
`A
`
`My name is Robert Thomas Stone.
`
`a company called Medical Designs Solutions,
`
`Q
`
`
`
`I'm the CEO of
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`Incorporated.
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`A
`
`We do medical device development, everything
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`Page 582
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`ranging from feasibility studies to full—fledged design and
`
`handing over to manufacturing.
`
`Q
`
`A
`
`Q
`
`And how long have you been at your position?
`
`I
`
`formed the company in November of 2011.
`
`Okay. Would you please briefly summarize your
`
`education for the Court.
`
`A
`
`
`My education began with a year or premed at
`
`Pepperdine University, after which I
`
`joined the United
`
`States Navy.
`
`I had three years and eight months of formal
`
`schooling in the Navy being trained as a nuclear
`
`electronics technician, spent
`
`two years teaching nuclear
`
`to the
`
`
`
`engineering, and then spent
`
`time on the USS Bainbridge,
`
`after which leaving the Navy I went
`
`to Virginia Tech where
`
`I obtained a bachelor of science in electrical engineering
`
`
`and a master of science in electrical engineering. And
`
`then I went
`
`to Stanford University and obtained a Ph.D.
`
`in
`
`electrical engineering with a specialty in medical
`
`imaging.
`
`Q
`
`You've touched on it a bit, but would you
`
`explain your professional experience working with
`
`radioactive materials.
`
`A
`
`Certainly.
`
`The time in the NaVy was either at a
`
`prototype for the USS Bainbridge or teaching at the
`
`prototype. We handled all forms of radioactive material.
`
`Everything from contamination to sources,
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`instrumentation that would be used in measuring and have
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`Page 583
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`internal sources,
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`to transferring highly radioactive
`
`nuclear fuel.
`
`Q
`
`That was the Navy.
`
`You do you have other
`
`experience working with radioactive materials?
`
`A
`
`Yes. When I left the Navy and went
`
`to Virginia
`
`Tech,
`
`I managed a nuclear reactive facility where we did
`
`neutron activation analysis and other types of research in
`
`teaching students as well as maintaining an analytical
`
`laboratory.
`
`Q
`
`Can you give us some type of ballpark how many
`
`years of experience do you have with working with
`
`radioactive materials?
`
`A
`
`I believe it was eight years at Virginia Tech
`
`and six years in the Navy. That's about 14 years.
`
`Q
`
`14 years. Okay.
`
`Do you have professional
`
`experience working with medical devices?
`
`A
`
`Q
`
`A
`
`I do.
`
`Why don‘t you explain that experience to the
`
`My first experience working with medical devices
`
`I‘ve
`
`was as a student at Stanford when I assisted in the design
`
`of a medication infusion system and then met
`
`two physicians
`
`where in 1983 I left Virginia Tech and joined a company
`
`called Nellcor, which was a medical device company.
`
`
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`been working with medical devices ever since.
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`Page584
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`Q
`
`What kind of devices do you have experience
`
`working on?
`
`A
`
`Everything from noninvasive diagnostic devices
`
`to implantable therapeutic devices.
`
`Q
`
`Okay. And do you have experience preparing
`
`prototype medical devices for market?
`
`A
`
`Q
`
`Yes.
`
`And, again, can you give us a forsinstance with
`
`That process has evolved over the years from
`
`representative devices.
`
`A
`
`Sure.
`
`
`One foruinstance would be working with a
`
`company called Natus Medical.
`
`I
`
`took a prototype of a
`
`breath analyzer that had been developed at Stanford and
`
`converted it over into something that could measure the
`
`rate at which blood was breaking down in the baby, and that
`
`became a commercial product.
`
`Q
`
`Okay- Are you familiar with how design
`
`processes for medical devices might be different from
`
`non—medical devices that might be released commercially in
`
`the market?
`
`A
`
`Surely.
`
`In the United States in order to obtain
`
`approval
`
`from the FDA to put a medical device on the
`
`market,
`
`its design and development and manufacturing all
`
`are controlled by something called GMP, good manufacturing
`
`procedures.
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`basically handling only the manufacture where now it
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`Page 585
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`handles everything from the time the product design process
`
`begins.
`
`Q
`
`Okay.
`
`And again in some type of ballpark range
`
`can you please tell the COurt how much experience you have
`
`working on medical device design and development.
`
`A
`
`Medical device and design development
`
`from 1983
`
`to the present,
`
`I believe that's about 36 years.
`
`MR. HAILS:
`
`80, Your Honor, we tender the
`
`witness as an expert
`
`
`in the field or medical devices and
`
`radiation protection systems.
`
`MR. DAVIS:
`
`No objection, Your Honor.
`
`MR. KOO:
`
`No objection, Your Honor.
`
`JUDGE CHENEY: Without objection, Dr. Stone will
`
`be accepted as an expert
`
`in the fields offered.
`
`BY MR. HAILS:
`
`Q
`
`Will you please explain your role in this
`
`investigation?
`
`A
`
`
`I was asked to look at the patents that are in
`
`concern here and determine whether I believe those patents
`
`were valid.
`
`I was also asked to look at the —— at the
`
`Ruby 3 product to determine if it infringed those.
`
`I was
`
`asked to look if I saw any indication, any evidence of
`
`Were you asked to develop opinions regarding
`
`copying in this matter.
`
`Q
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`inventorship in this investigation?
`
`A
`
`Q
`
`Yes.
`
`And with respect to your invalidity opinions,
`
`were you asked to develop an opinion on obviousness issues
`
`for this investigation?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes,
`
`I was.
`
`And how about anticipation?
`
`No. Other than the Ruby 3 anticipation.
`
`Let's —— did you prepare demonstrative materials
`
`to explain your opinions to the Court?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes,
`
`I did.
`
`Can we pull up the PowerPoint version of RDX—2.
`
`What is this exhibit, sir?
`
`This is the first slide of the demonstratiVes
`
`prepared for this testimony.
`
`Do you have a clicker?
`
`I do.
`
`All right. Why don‘t we start and walk through,
`
`what is positron emission tomography at a high level?
`
`why don’t you just take us through the first set of
`
`materials, please. Working?
`
`A
`
`Q
`
`NO.
`
`We had this working.
`
`So now we are at slide
`
`two.
`
`I
`
`think we‘ve talked on it, discussed it through
`
`other witnesses, but would you please explain to the COurt
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`A
`
`Positron emission tomography at a high level is
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`Page587
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`injecting a radioactive tracer into the body which emits
`
`positrons. That positron rapidly loses any excess energy
`
`it has and unites with an electron and annihilates
`
`converting the mass of the electron and the positron into
`
`energy,
`
`reducing two gamma rays which go in exactly
`
`opposite directions.
`
`Q
`
`Okay.
`
`So we have two images.
`
`One here on the
`
`left and one here on the right. What is the animation on
`
`photodiode or photomultiplier, which counts those light
`
`the left showing?
`
`A
`
`The animation on the left is showing the
`
`radioactive tracer giving off its energy.
`
`The one on the
`
`right shows the process whereby that energy ends up
`
`ultimately being converted into an image in that the
`
`photons if emitted at the same time or exactly the same
`
`time as can be measured by the instrumentation is counted,
`
`and a line is drawn between two elements of the detector,
`
`and after a large number of those lines have been drawn,
`
`then an image can be computed using a process called back
`
`projection using the most common tracers.
`
`Q
`
`Can we break it down a little bit. What's the
`
`blue ring shown in the image on the right?
`
`A
`
`The blue ring is an array of detectors,
`
`typically they are crystals which emit light in a
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`
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`PageSSS
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`I'm going to call it a green blob and a red blob
`
`inside of the green glob.
`
`Do you see that?
`
`The most common PET tracers in use in the year
`
`A
`
`Q
`
`A
`
`Yes.
`
`What‘s that?
`
`We have cross section of the torso,
`
`the red blob
`
`would be the constructed image of in this case cardiac
`
`tissue that's been generated as a result of those many
`
`lines being drawn.
`
`Q
`
`We have the tracer and arrows coming out
`
`in
`
`opposite direction from the tracer.
`
`It hits the rings.
`
`And explain again how does that phenOmena get
`
`turned into
`
`useful
`
`image data?
`
`A
`
`Well, as shown here we have a line drawn across
`
`—— I‘m sorry.
`
`Q
`
`A
`
`Back. Back.
`
`One more. All right.
`
`As shown here we have a line drawn across, and
`
`that line, when many, many of those lines are drawn, and
`
`using appropriate mathematical algorithm,
`
`in CT it's called
`
`convolution back projection, and an image of where those
`
`emissions took place in a computer.
`
`Q
`
`Okay. And the —— I
`
`think the time frame we are
`
`going to be discussing is the mid-2000s.
`
`In the mid-20003,
`
`what were the common PET tracers in use?
`
`A
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`2000 w0uld have been fluorodeoxyglucose.
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`Page 539
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`Q
`
`A
`
`What about rubidium, was rubidium popular at
`
`It was being used. CardioGen 82 had already
`
`been in use so Rubidium~82 was in use at that time.
`
`Q
`
`Let‘s move forward, please. All right.
`
`And
`
`
`
`slide three you have a little bullet for an infusion
`
`system. What's an infusion system?
`
`A
`
`Just to make clear, we are not talking about the
`
`imaging system that's on the right. What we are talking
`
`about is the electromechanical fluidic system which
`
`controls the eiution of the source as it goes from the
`
`
`
`saline bag through a source of radioactive material and
`
`into the patient.
`
`It has no
`
`Q
`
`A
`
`And so what's the job of the infusion system?
`
`:t is to safely inject the correct dose into the
`
`
`
`patient while maintaining radiation safety for the user.
`
`Q
`
`Let‘s move forward please.
`
`I‘m going to jump to
`
`slide six. Here you have a timeline presented. Will you
`
`please explain Bracco‘s development of its CardioGen
`
`system?
`
`A
`
`Certainly.
`
`In 1989,
`
`the FDA approved the
`
`CardioGen 82 which is the device shown there in the
`
`diagram. This is a device that had manual strontium
`
`breakthrough tests still on the market
`
`today.
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`computer interface and from 1989 to 2006,
`
`they were the
`
`Page590
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`sole supplier of Rubidium—BZ infusion systems in the 0.3.
`
`and they made no significant upgrades during that time.
`
`Q
`
`You said it didn‘t have a computer interface.
`
`What kind of interface did it have?
`
`A
`
`It had some digital logic that had included
`
`controls such as sub wheels, knobs, switches push buttons
`
`and indicators.
`
`Q
`
`Let's kick Out of the PowerPoint for a moment,
`
`please, and pull up RX-216.
`
`Do you recognize this
`
`document, sir?
`
`A
`
`Q
`
`A
`
`Yes.
`
`What is this document?
`
`This is a user guide for the CardioGen 82 also
`
`is this document?
`
`known as the 510.
`
`Can we pull up page 22 of this document. What
`
`A
`
`Well, as I stated we have light emitting diodes,
`
`knobs, switches, buttons, all of which are the control
`
`process that is done manually through the system.
`
`Q
`
`And you said it was a manual strontium
`
`breakthrough test is that correct?
`
`A
`
`Q
`
`Correct.
`
`Let's move to page 45 of this document.
`
`So what
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`A
`
`This is the first page of a worksheet that
`
`Page 591
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`describes what a user would do in order to do a strontium
`
`breakthrough test.
`
`Q
`
`And if we can move forward two pages. Three
`
`pages.
`
`You see this chart. This is on page I think 48 of
`
`RX~216.
`
`A
`
`Q
`
`I do.
`
`This is the chart that,
`
`a chart similar to the
`
`It is now RX—l 44 page 10. Let's move forward.
`
`one that Dr. Lewin was explaining earlier in testimony,
`
`is
`
`that correct?
`
`A
`
`Q
`
`That‘s correct.
`
`So am I correct that people are measuring
`
`activity and putting these figures in by hand to calculate
`
`strontium breakthrough in the CardioGen Model 510?
`
`A
`
`Q
`
`That is correct.
`
`Let's move back to the PowerPoint please. All
`
`right.
`
`Can you move forward please.
`
`2006. What happens
`
`in 2006?
`
`A
`
`2006,
`
`the Klein thesis was published it's also
`
`called the University of Ottawa infusion system.
`
`They
`
`
`invited Bracco to participate in a request for information.
`
`Bracco showed no apparent interest.
`
`Q
`
`Okay.
`
`Just for the record this exhibit number
`
`that's shown here is JX—Sl, but it has kind of evolved over
`
`time.
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`Then what happens?
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`PageS92
`
`A
`
`In 2008, Bracco filed a patent application a
`
`figure of which is shown on the rightehand side and then in
`
`2009,
`
`they supplemented that application to disclose an
`
`on—board dose calibrator.
`
`Q
`
`That's slide seven of your presentation. Will
`
`you continue.
`
`We are at slide eight.
`
`Please explain what
`
`was the University of Ottawa doing at this time?
`
`
`
`Please continue.
`
`A
`
`The University of Ottawa had developed something
`
`they called the RBES system that possessed some really
`
`significantly advanced features.
`
`They had a touch screen
`
`interface they had automated the strontium breakthrough
`
`test they had three types of elutions instead of a single
`
`type that included the constant activity elution we
`
`discussed earlier in this, we, it's been discussed earlier
`
`in this proceeding.
`
`They provided the saline push to the
`
`patient maintaining more accurate, achieving more accurate
`
`doses and they had a longer generator life.
`
`Q
`
`Let‘s move forward please.
`
`2016, you talked
`
`about how Bracco was invited to participate. What about
`
`Ottawa‘s dealings with DraxImage?
`
`JUDGE CHENEY:
`
`Just to clarify the record,
`
`Counsel, did you mean 2006 or 2016.
`
`MR. HAILS:
`
`2006.
`
`I'm sorry. Did --
`
`JUDGE CHENEY:
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`BY MR. HAILS:
`
`Page593
`
`Q
`
`A
`
`Yes, sir.
`
`Please explain what happened in 2006.
`
`Well, as we said Ottawa invited several
`
`companies to have a request for information.
`
`They were
`
`looking for a partner to commercialize their prototype
`
`system. Bracco showed no interest and DraxImage ultimately
`
`won that request for information.
`
`Q
`
`A
`
`Please move forward. All right.
`
`Then what?
`
`2007, Ottawa licenses the REES technology to
`
`Jubilant DraxImage.
`
`Q
`
`Now, here you show a picture taken from Exhibit
`
`106.
`
`Is this the only document that you reviewed that
`
`explains the development of the University of Ottawa team?
`
`A
`
`Q
`
`No.
`
`It's not.
`
`Do you have a binder in front of you that
`
`contains other materials that you've reviewed?
`
`A
`
`Q
`
`Yes,
`
`I do.
`
`Would you pull it out, please. All right.
`
`I'd
`
`like to just check that my list of exhibits is the same as
`
`the one that you have. Does your binder include RXe80,
`
`RX—86, RX-88, RX-89, RX-QO, RX-Ql, RX-92, RX—93, RX-97,
`
`RX—lOO, RX—102, RX—104, RX—lUS, RX—106 and 107?
`
`Now we are
`
`A
`
`Q
`
`Yes.
`
`All right.
`
`Thank you.
`
`You can put that aside.
`
`Let‘s move forward, please. Okay.
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`on slide 9.
`
`What are you showing here on this slide?
`
`A
`
`What we are showing here is the similarity,
`
`in
`
`fact,
`
`the identical system components functionally between
`
`the University of Ottawa system that was developed first
`
`disclosed in 2005 and then Bracco‘s aSSerted patents which
`
`were filed in 2009.
`
`No. That‘s fine. Let's move forward please.
`
`Q
`
`So why don't you walk us through this.
`
`How do
`
`
`the components of the Ottawa system from 2005 compare to
`
`the system disclosed in Bracco's asserted patents?
`
`A
`
`Well,
`
`they both have a saline SOurce.
`
`They both
`
`have a pump for moving the saline.
`
`They both have a
`
`pressure sensor for monitoring the pressure in the system.
`
`They both have a generator valve which can divert flow
`
`either to the generator both systems or to a bypass line in
`
`both systems.
`
`They also have an activity counter to
`
`monitor the dose of radiation as it's being delivered.
`
`They have a patient valve which can direct the dose either
`
`to the patient or the calibrator line or divert that to the
`
`waste bottle where they both have a waste bottle and why
`
`they both have a dose calibrator it's not shown here on the
`
`Bracco system.
`
`Okay.
`
`Sorry.
`
`Q
`
`A
`
`O
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`Slide 10.
`
`On slide 10 you have the subtitle generating
`
`Page 595
`
`rubidium eluate through the strontium rubidium generator.
`
`Can you explain?
`
`dose calibrator?
`
`A
`
`Both systems operate essential any in the same
`
`fashion. Saline is pumped through the generator valve out
`
`the output port of the generator through the radiation
`
`counter through the patient valve to the patient.
`
`Same
`
`path both systems.
`
`Q
`
`I was going to ask just for the record, does the
`
`same process occur in the Bracco system?
`
`A
`
`Q
`
`Functionally the same system.
`
`Let‘s move forward please. Okay. We are at
`
`slide ll and you have part of your title automating
`
`strontium breakthrough testing. Will you please explain
`
`how does this phenomenon occur in the two systems?
`
`A
`
`Well, it's almost identical with regard to the
`
`fluid path in both systems with the difference —— only
`
`difference being at this far end instead of going to the
`
`patient it goes to an eluant reservoir not shown here
`
`that's in the dose calibrator where,
`
`in the case of the
`
`University of Ottawa,
`
`that dose comes -- where the
`
`calibration takes plaCe.
`
`O
`
`In the University of Ottawa system eluant comes
`
`out of the generator through that pink path through the
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`A
`
`That is correct.
`
`Page 596
`
`Q
`
`And does that process also occur in the system
`
`disclosed in the Bracco patent?
`
`A
`
`Q
`
`Yes.
`
`The eluant comes out of the hot pink path into
`
`the dose calibrator;
`
`is that correct?
`
`A
`
`Q
`
`That‘s correct.
`
`Move forward please. Slide 12.
`
`You have a
`
`reference to a bypass path in your title.
`
`Please explain
`
`how this phenomenon occurs in the two systems.
`
`A
`
`In both systems we have the opportunity to
`
`switch the flow from going through the generator to go
`
`through the bypass line.
`
`Instead. Going on to the
`
`patient.
`
`
`The bypass line can be flushed,
`
`so that the
`
`patient line can be flushed and any residual radioactivity
`
`can be removed.
`
`Q
`
`Earlier in testimony we've been hearing about
`
`saline pushes. Are you familiar with that?
`
`systems?
`
`A
`
`Q
`
`concept?
`
`A
`
`Q
`
`Yes.
`
`Is this concept related to that saline push
`
`It is. That‘s how the saline push would occur.
`
`All right. And does the operational,
`
`the
`
`operation of the bypass path,
`
`is that the same in both
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`A
`
`Yes, it is.
`
`PageSQ?
`
`Q
`
`Let‘s move forward please.
`
`We are on slide 13.
`
`Part of you‘re title says "diverting rubidium eluate to a
`
`waste bottle." Would you please explain how does this
`
`phenomenon occur in the two systems?
`
`A
`
`Yes.
`
`On a daily basis whenever the generator or
`
`lines are changed,
`
`they need to be flushed.
`
`The generator
`
`needs to be flushed to remove Strontium breakthrough,
`
`so we
`
`
`
`Please proceed, Mr. Hails.
`
`once again pump saline through the generator valve through
`
`the generator and actually throagh on —— to the waste
`
`bottle.
`
`So any of that material that we don‘t want
`
`to
`
`eluate to a patient goes to a waste bottle.
`
`Q
`
`So that was you describing the Ottawa design.
`
`Does that process occur in the Bracco disclosure?
`
`A
`
`Q
`
`Same process occurs in the Bracco.
`
`Let‘s move to slide 14, please. Okay.
`
`JUDGE CHENEY:
`
`Probably a good place to take our
`
`afternoon break.
`
`Take 15 minutes.
`
`We are off the record.
`
`(Recess.)
`
`JUDGE CHENEY:
`
`We are back on the record in the
`
`1110 investigation.
`
`
`We are in the midst o:
`
`the direct examination of
`
`Dr. Stone, Respondents‘ witness, here to talk about
`
`the
`
`validity of the considered patent.
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`HHSDOCUMENTCONEMNSCONHDENUALDWOMWAHON
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`BY MR. HAILS:
`
`Page593
`
`Q
`
`I
`
`think when we broke we were referring to slide
`
`
`14. Here we have a timeline referring to Jubilant. Will
`
`you please walk us through this material?
`
`A
`
`Certainly.
`
`In 2007 Jubilant had taken a license
`
`and began working with the version 1 system that had been
`
`developed in 2004, and by 2010 they had developed a version
`
`2 system.
`
`Then beginning in 2010 they began development of
`
`the so—called V3, which is the -- a product that's been
`
`under c0nsideration today.
`
`Q
`
`Let's move forward, please. All right. That's
`
`V2;
`
`is that correct?
`
`A
`
`Q
`
`That is V2.
`
`Move forward, please. All right.
`
`And then
`
`again walk us through the material on the V3?
`
`A
`
`All right.
`
`On the material
`
`in the V3 in 2010
`
`Jubilant had completed version 2 and began development on
`
`V3 by 2013 they submitted a u5er manual
`
`to the FDA.
`
`And
`
`then in 2015 they completed the design of the version 3.
`
`Then in 2016 the FDA approved the Ruby system that's here
`
`Did you remember that?
`
`today.
`
`Q
`
`Earlier you had testified that the system
`
`developed by the University of Ottawa provided several
`
`advantages over Bracco's predecessor CardioGen product.
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`A
`
`Yes,
`
`I do.
`
`Page 599
`
`Q
`
`Does the —— does the JDI's Ruby system employ
`
`the same advantages?
`
`A
`
`Q
`
`Yes, it does.
`
`Let me rattle them off just to be
`
`the Ruby system have a touchsheen interface?
`
`A
`
`Q
`
`It does.
`
`Does JDI's Ruby system perform an automated
`
`strontium ——
`
`A
`
`Yes, it does.
`
`JUDGE CHENEY:
`
`The court reporter is doing a
`
`great
`
`job, but -- let's —— both you and the witness can
`
`just breathe a little. Relax. This is fun.
`
`MR. HAILS: Well,
`
`I'm glad.
`
`
`BY MR. HAILS:
`
`Q
`
`Does JDI's Ruby system perform constant activity
`
`elutions?
`
`A
`
`Q
`
`patients?
`
`A
`
`Q
`
`It does.
`
`Does JDI's Ruby system perform a saline push to
`
`Yes, it does.
`
`And does JDI‘s Ruby system have a
`
`longer
`
`Do you mind if I refer to that CardioGen 82 as
`
`generator life than the predecessor CardioGen 82?
`
`Yes, it does.
`
`A
`
`Q
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`the Model 510 to keep it distinct from for example the
`
`Page 600
`
`1700?
`
`A
`
`Q
`
`That would be fine.
`
`All right.
`
`Thank you.
`
`You have an exhibit here shown as JX—052C.
`
`Do
`
`you see that?
`
`A
`
`Q
`
`Yes.
`
`All right.
`
`And is this the only document that
`
`you reviewed to develop your understanding of the JDI
`
`development product?
`
`A
`
`Q
`
`No.
`
`
`All right. Will you look in front of you and
`
`see if you have a binder labeled JDI development documents.
`
`Can you pull them out.
`
`A
`
`Q
`
`Yes.
`
`Will you pull it out for me.
`
`Does that binder
`
`contain other documents that you reviewed to develop your
`
`understanding of the Jubilant design product?
`
`A
`
`Q
`
`Yes,r
`
`it does.
`
`Let me ask you if those binders include the
`
`following exhibits.
`
`I have it as JX—007?
`
`JX—14C?
`
`Yes.
`
`JX—013?
`
`Yes.
`
`A
`
`Q
`
`A
`
`Q
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`Yes.
`
`Page601
`
`JX—lSC?
`
`Yes.
`
`JX—22C?
`
`Yes.
`
`JX—32C?
`
`Yes.
`
`JX—33C?
`
`Yes.
`
`JX-39C?
`
`Yes.
`
`What is shown here on slide 15?
`
`There is JX—52 on the screen.
`
`Yes.
`
`RX—78C?
`
`Yes.
`
`RX—143C?
`
`Yes.
`
`RX—lSS?
`
`Yes.
`
`And RX-172C?
`
`Yes.
`
`All right.
`
`Thank you.
`
`Can we move forward, please.
`
`80 now we are on
`
`slide 15.
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`
`A
`
`On the left—hand side of the slide is the
`
`Page602
`
`University of Ottawa's REES system which was disclosed in
`
`the Klein thesis in 2005 and 2006.
`
`On the right-hand side
`
`is Jubilant's FDA filing that they filed in 2011 which is
`
`the same components of the diagram with a minor
`
`repositioning of one element.
`
`Q
`
`I was going to ask.
`
`Is this how Jubilant
`
`explained its system to the FDA?
`
`A
`
`Q
`
`Yes, it is.
`
`And here you show an excerpt
`
`from a single
`
`RX-48?
`
`exhibit, RX—Bl, at page 11.
`
`Is this the only document that
`
`
`you reviewed to developing your understanding of Jubilant‘s
`
`representations to the FDA?
`
`A
`
`Q
`
`No.
`
`Do you have a binder in front of you containing
`
`JDI FDA documents?
`
`A
`
`Q
`
`I do.
`
`Can you pull it out, please. Did you review the
`
`documents in the binder to develop your understanding of
`
`Jubilant's dialogue with the FDA regarding its system?
`
`A
`
`Q
`
`Yes,
`
`I did.
`
`Let me ask you if these exhibits are contained
`
`in that binder.
`
`RX—3l?
`
`Yes.
`
`A
`
`Q
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`Yes.
`
`RX—ST?
`
`Yes.
`
`RX—SB?
`
`Yes.
`
`RX-SQC?
`
`Yes.
`
`And RX—62C?
`
`Yes.
`
`Move forward. Okay.
`
`Now we are on slide 16 and
`
`A
`
`Q
`
`
`
`a PET infusion system with
`
`I
`
`think you've taken us through 2016, at least the
`
`beginning. Why don‘t you pick it up there. What happened,
`
`what else happened in 2016?
`
`A
`
`Well,
`
`in 2016,
`
`the FDA approved the Ruby system.
`
`Bracco obtained the Jubilant product literature frOm the
`
`FDA via a Freedom of Information Act request.
`
`And they
`
`copied the Ruby features into new claims that have become
`
`the asserted patents here today.
`
`Q
`
`Okay. Move forward, please.
`
`I want
`
`to jump
`
`ahead to slide 70 and talk about prior art. Will you
`
`advance, please. Here on slide 71 you have a title "Major
`
`Sources of Prior Art
`
`" Would you please explain —-
`
`introduce these prior art references to the Court.
`
`A
`
`Well, first we have Bracco's own CardioGen 82,
`
`which was publicly used in 1989,
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`Rudidium—82. Next we have the Klein thesis published in
`
`Page 604
`
`2006, it discloses a PET infusion system for Rubidium—82.
`
`Next, we have the Tate application filed in 200?, it
`
`discloses a PET infusion system using FDG.
`
`And then
`
`finally we have the Medrad Intego product, which was
`
`offered and sold in 2008, and it also includes —— there's a
`
`PET infusion system.
`
`Its material has been requested to be
`
`redacted,
`
`I understand.
`
`MR. HAILS:
`
`So, Your Honor, it was produced to
`
`us under CBI so we have redacted slides here and we will
`
`ask eventually to go on to the confidential record for this
`
`third—party CBI,
`
`to discuss just so you are aware.
`
`JUDGE CHENEY:
`
`I'm a little confused.
`
`MR. RAILS: Well,
`
`I don't blame you.
`
`tell you was the basis for keeping this confidential?
`
`
`
`JUDGE CHENEY:
`
`So we are going to have an
`
`argument about something known to the world that will not
`
`be known to the world.
`
`MR. HAILS:
`
`We are not making the claim of C81.
`
`The claim of CBI was made by the producing party.
`
`I'm not
`
`sure this is confidential and we have evidence that it was
`
`publicly sold, offered for sale and used, but this is what
`
`it is.
`
`JUDGE CHENEY:
`
`So when you pushed back on the
`
`party from whOm you sought this information, what did they
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`MR. HAILS:
`
`They did not explain in depth.
`
`They
`
`Page 605
`
`maintained their claim of CBI.
`
`And we —— we don‘t have
`
`their information. We are not
`
`in a position to challenge
`
`that.
`
`JUDGE CHENEY:
`
`So if I were to make an
`
`adjudication about whether or not this is CBI, which I
`
`am
`
`entitled to do under the Commission rules, who will be
`
`representing their interests?
`
`MR. HAILS:
`
`We have contact
`
`information for
`
`their counsel and we can certainly get
`
`in touch with them
`
`
`
`and notify them of your issues, see i: they want
`
`to come
`
`here and defend that claim.
`
`JUDGE CHENEY:
`
`Like tomorrow?
`
`
`MR. HAILS:
`
`We can ask.
`
`But as a practical
`
`the confidentiality claim to this material.
`
`matter,
`
`I doubt it, but
`
`I will certainly have somebody make
`
`that -- make that --
`
`JUDGE CHENEY:
`
`Surely this is something that you
`
`would foresee when you are going to present a prior art
`
`argument based on secret prior art that you would have made
`
`some arrangements about this.
`
`
`MR. HAILS: Again, we have shown these slides to
`
`counsel for —— they're called the Bayer Company,
`
`for the
`
`Bayer Company. We have explained to them that we would
`
`like to disclose that in court and they declined to waive
`
`
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`JUDGE McNAMARA: This is a —— so what kind of an
`
`PageéO6
`
`argument are we relying on this art for?
`
`Is it a 1028?
`
`MR. HAILS:
`
`
`It‘s prior art under -—
`
`JUDGE CHENEY: Or is it under the AI? What are
`
`we talking about here?
`
`MR. HAILS:
`
`It's 102A.
`
`It's all publicly known
`
`
`
` forehand. Before their invention.
`
`JUDGE CHENEY:
`
`So are you relying on the
`
`article,
`
`
`the sale of the article itself, not on a printed
`
`publication?
`
`MR. HAILS: That's correct.
`
`
`
`JUDGE CHENEY:
`
`Do they sell this thing under an
`
`obligation of confidentiality?
`
`MR. HAILS:
`
`I don't know the circumstances.
`
`JUDGE CHENEY:
`
`How did you become aware of it?
`
`MR. HAILS:
`
`We
`
`found material __ again,
`
`this is
`
`not —e we
`
`found material online that suggested they were
`
`being sold and marketed.
`
`
`It is a different document
`
`than
`
`the document presented here.
`
`And we pursued it through
`
`
`discovery and we obtained information on their sales of
`
`product.
`
`JUDGE CHENEY: Does the third party contend that
`
`the sale is confidential or only that the document that
`
`they provide you in discovery is confidential?
`
`
`MR. HAZLS:
`
`I don't know to that level
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`certainly know that they have —— we have sales documents
`
`Page 607
`
`which we will —— we are prepared to discuss, again, on the
`
`confidential record, and we have materials on the product,
`
`which we are prepared to discuss.
`
`And it's not our claim
`
`of confidentiality.
`
`JUDGE CHENEY: But it is your burden to prove by
`
`clear and convincing evidence that this was known to the
`
`public.
`
`And I would expect you to have a few more answers
`
`than you have today.
`
`MR. HAILS:
`
`I understand.
`
`JUDGE CHENEY: Okay. Well —— it's not
`
`looking
`
`good for your burden so maybe you want
`
`to do something
`
`about that.
`
`that you reviewed to develop your opinions regarding its
`
`MR. HAILS: We'll check.
`
`JUDGE CHENEY: Okay.
`
`Proceed.
`
`BY MR. HAILS:
`
`Q
`
`Okay.
`
`You talked about
`
`the CardioGen cart.
`
`How
`
`do you know it was publicly used in 1989?
`
`A
`
`That's what Bracco claims in their original
`
`complaint.
`
`Q
`
`A
`
`Q
`
`We have an except
`
`from RX—0207.
`
`Do you see
`
`Yes.
`
`Is this the only document on the CardioGen 82
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`THIS DOCUMENT CONTAINS CO
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