UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`JUBILANT DRAXIMAGE INC.,
`Petitioner,
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`____________
`
`IPR2018-01448 (Patent 9,299,468 B2)
`IPR2018-01449 (Patent 9,299,467 B2)
`IPR2018-01450 (Patent 9,299,468 B2)
`____________
`
`Record of Oral Hearing
`Held: October 29, 2019
`___________
`
`BEFORE: HYUN J. JUNG, GEORGE R. HOSKINS, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`JUBILANT DRAXIMAGE INC.,
`Petitioner,
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`____________
`
`IPR2018-01448 (Patent 9,299,468 B2)
`IPR2018-01449 (Patent 9,299,467 B2)
`IPR2018-01450 (Patent 9,299,468 B2)
`____________
`
`Record of Oral Hearing
`Held: October 29, 2019
`___________
`
`BEFORE: HYUN J. JUNG, GEORGE R. HOSKINS, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
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`IPR2018-01448 (Patent 9,299,468 B2)
`IPR2018-01449 (Patent 9,299,467 B2)
`IPR2018-01450 (Patent 9,299,468 B2)
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`APPEARANCES
`
`
`ON BEHALF OF THE PETITIONER:
`ROBERT L. HAILS, ESQUIRE
`T. CY WALKER, ESQUIRE
`BAKER HOSTETLER
`Washington Square, Suite 1100
`1050 Connecticut Avenue N.W.
`Washington, D.C. 20036
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`BARRY J. SCHINDLER, ESQUIRE
`HEATH J. BRIGGS, ESQUIRE
`GREENBERG TRAURIG
`500 Campus Drive, Suite 400
`Florham Park, New Jersey 07932
`
`
`
`
`
`
`The above-entitled matter came on for hearing on October 29, 2019,
`commencing at 12:59 p.m., at the U.S. Patent and Trademark Office,
`Madison Building, 600 Dulany Street, Alexandria, Virginia, 22314.
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`IPR2018-01449 (Patent 9,299,467 B2)
`IPR2018-01450 (Patent 9,299,468 B2)
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` (Proceedings begin at 12:59 p.m.)
` JUDGE JUNG: This is the oral hearing for IPR 2018-01448,
`-01449, and-01450.
` In these proceedings, petitioner, Jubilant
` Draximage, challenges claims of U.S. Patent Nos. 9,299,467
` and 9,299,468, both of which are owned by Bracco
` Diagnostics.
` Starting with the petitioner's counsel, and followed
` by the patent owner's counsel, would you please state your
` names for the record.
` MR. HAILS: Robert Hails for Jubilant Draximage.
` JUDGE JUNG: Thank you.
` MR. WALKER: Cy Walker, Baker Hostetler, also for
`Jubilant.
` JUDGE JUNG: Welcome, Mr. Walker.
` MR. SCHINDLER: Harry Schindler for the patent
`owner.
` With me is Heath Briggs, and there are some others.
`Julie Bookbinder is our colleague from Greenberg Traurig.
` And there are the two Bracco representatives, Vito
`DeBario and Guyan Liang. I'm terrible with names, so
`apologize.
` JUDGE JUNG: Welcome to you all.
` MR. SCHINDLER: Thank you, Your Honor.
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` JUDGE JUNG: As we stated in the trial hearing
`order, each party has one hour of total time to present their
`arguments for all three cases. You may present your cases in
`any order that you wish, just make it clear which case you
`are talking specifically about.
` Petitioner will proceed first, followed by patent
`owner, and each side may reserve time for rebuttal.
` Two reminders. Please refer to your demonstratives
` by slide number. And if you have an objection, do not
` interrupt the presentation to make that objection, please
` save it towards the end of the presentation.
` And I noticed there's no objections to the
` demonstratives in the record, so I just want to verify that.
` Mr. Hails, is that correct, there are no objections
` to patent owner's demonstratives?
` MR. HAILS: That's correct, Your Honor.
` JUDGE JUNG: And Mr. Schindler, no objections to
`petitioner's demonstratives?
` MR. SCHINDLER: Yes, Your Honor.
` JUDGE JUNG: Okay. Thank you.
` All that said, Mr. Hails, you may proceed when
` you're ready.
` MR. HAILS: Thank you, Your Honor.
` Can you give me one moment, please?
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` (Pause in the proceedings)
` MR. HAILS: All right. Good afternoon. May it
`please the Board.
` Again, Bob Hails representing Jubilant Draximage.
` I'd like to reserve, let's call it 20 minutes for
` rebuttal time, please.
` JUDGE JUNG: You may begin.
` MR. HAILS: Thank you.
` All right. So you've seen the demonstratives and
`you've seen the arguments in all three IPRs.
` We obviously have a structured presentation for you
` today, but certainly, if there are any questions or if there
` are any issues that you want us to focus on, please let us
` know and we'd be happy to accommodate you.
` So going through the demonstratives. The first
` couple slides are just introductory, repeating the claim
` language in case we need it.
` On Slide 5, we have just a reminder at a high level,
` you know, how -- the structure of the prior art, the primary
` reference Klein matches up against the -- the claims, and we
` took Claim 1 from the '467 patent just as a representative
` example.
` The claim refers to a shielding assembly for a
` generator. That's generally color-coded in red throughout
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` our materials and refers to a computer with a variety of
` different operations. The computer is color-coded in green
` throughout the operation. And then also to this dose
` calibrator, and that's color-coded in blue throughout the
` presentation materials.
` In Slide 6, we see the block diagram that Klein
` gives us in terms of how the system operates.
` There are very few disputes between us. We'll go
` through them momentarily. But this system basically
` operates as claimed throughout. The generator operates as a
` generator. The dose calibrator operates to receive test
` samples from the generator and to report things to a
` computer. The computer runs the strontium breakthrough
` test.
` On Slide 7, we have a listing of the issues in
` dispute, and they're organized by IPR, but perhaps it's
` easiest to go to Slide 8, and that organizes them by issue,
` and this is the sequence that we'll see in today's
` presentation.
` We've nicknamed this element about the computer a
` strontium breakthrough test as the lockout limitations, and
` that is -- that is an issue throughout all three IPRs.
` There's an issue as to the location of a dose
` calibrator, and that is an issue only for one IPR, and
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` that's the -1448.
` And then there are issues to the Bracco manual and
` to a declaration from an expert, Dr. Murphy, and those are
` issues in all three IPRs. We don't think they are
` meaningful, and we'll go through them, as well.
` All right. Let's go to Slide 10, please.
` This slide has an error in which there are five
` independent claims, and we only listed the language for four
` of them. Apologies. But the claim language that's -- the
` arguments that are presented here go through all claims.
` And the essence of the claim elements are the same.
` We'll look at claim -- the language from Claim 1 of the '467
` patent just for discussion purposes. It talks about a
` computer that is configured to prevent a patient infusion
` procedure if a breakthrough test result exceeds an allowable
` limit.
` Claim 24, which we neglected to include, is a method
` claim that recites preventing the patient infusion in that
` circumstance.
` Okay. So let's get grounded a little bit in terms
` of the technology that we're dealing with. We're dealing
` with a system that infuses radioactive material into people.
` Specifically, the desired radioactive material is
` called rubidium. Rubidium is fantastic because it has an
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` extremely short half-life, and which means that you can
` inject it, you can take your pictures, it can decay quickly.
` It's great.
` It is made from a substance called strontium which
` has a much longer half-life. And strontium is stuff you
` don't want to put into patients.
` And so this breakthrough test is a technique for
` making sure that the bad strontium stays out, and we're only
` dealing with the good rubidium going into patients. At the
` super-high level, that's what we're talking about.
` JUDGE JUNG: All right. Mr. Hails, before you move
`on, I just wanted to verify a couple of things.
` MR. HAILS: Sure.
` JUDGE JUNG: Other than the means plus function
`terms in Claim 21 of the -1450 proceeding, do you agree with
`patent owner that no other claim terms need an express
`interpretation?
` MR. HAILS: There are no claim construction issues.
`That's correct.
` JUDGE JUNG: Okay. And would you agree that Klein
`itself and some of the other asserted references reflect the
`ordinary level of skill in the art?
` MR. HAILS: Yes, I think so. That's right.
` JUDGE JUNG: Does that affect your arguments in any
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`way? I know there was a small dispute at the ITC about the
`definition of a person of ordinary skill in the art. But if
`we applied what we think is the level of ordinary skill in
`the art reflected in the references, does that affect your
`arguments in any way?
` MR. HAILS: Actually, I mean, we think that the
`references speak to somebody who matches our definition. Our
`definition, I would say, is -- as compared to theirs, skews a
`little bit more EE oriented. We're dealing with computer
`systems that control things, you know, and those kinds of
`aspects, and I think that it -- it better aligns with our
`definition.
` I'm -- our -- we've made this point in the briefing
`that their definition speaks more to medical practitioners,
`people who have experience working with these machines rather
`than building these machines, but -- but we think that --
`that Klein and Tate and those references are better aligned
`to our definition.
` JUDGE JUNG: Okay. And one last question for
`confirmation.
` MR. HAILS: Sure.
` JUDGE JUNG: The patent owner's declarant, Mr. Pelc,
`relies on his testimony from the ITC proceeding.
` Do you have any objections at all to his reliance or
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`reaffirmation of his ITC testimony for this proceeding?
` MR. HAILS: We don't. We think the testimony is not
`credible and -- but he speaks to the same issues in terms of,
`there was a computer lockout function in the ITC case, and
`there was an issue of the dose calibrator.
` So it's evidence, it's been submitted to you, and
` you can consider it. We think it's uninformative, and it's
` conclusory, and obviously, we think you should give it very
` little weight.
` JUDGE JUNG: Okay.
` MR. HAILS: But considering it, yes. That's --
` JUDGE JUNG: All right. Thank you.
` JUDGE MARSCHALL: And just to clarify. I take it
`that your position is you should prevail regardless of which
`definition for a POSITA that we adopt here.
` MR. HAILS: That's correct. We don't think it's
`material.
` Okay. Thank you.
` Okay. So we're at Slide 11, and we're talking about
` this computer lockout function.
` So let's -- let's talk about what Klein does in
` terms of managing this strontium breakthrough problem that
` we had alluded to.
` Klein describes a computer-controlled system. You
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` can see the computer right there. It's a -- it's a homemade
` system made in a university environment.
` He's got a desktop computer sitting there with a
` touchscreen display up top. He says that the user interface
` must be informative as relevant to our analysis. It allows
` the computer to control all features of the elution system.
` It also limits the user's input to ensure validity.
` Klein says that the interface is solely through the
` touchscreen which will display a keypad and an exit button.
` Other buttons and radio buttons are added only at
` relevant states, and they are immediately removed at the end
` of the each state.
` And it gives you an example here. He gives you an
` example of a screen which is -- it's a little fuzzy in the
` presentation. Hopefully, it's clearer in the materials.
` Choose run type. He's got eight candidate run types
` that are available, but three of them are grayed out, and he
` tells you that -- that for this particular functionality,
` you know, things like user IDs or other kinds of things give
` you access control, and certain people don't get access to
` the -- what are called the test elutions. Those are the
` ones in the yellow bubble in this -- in this drawing. If
` you don't have the right ID, you don't have those access
` rights, so that a computer that limits what you can do.
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` Klein describes something he calls a daily protocol.
` A daily protocol is a three -- it's not stages, because you
` can repeat the patient elutions over and over again, but
` there are three states to it. And he tells you that every
` night at midnight, the protocol needs to be started anew.
` He says that the calibration -- or let's go through the
` protocol first.
` He's got a daily flush stage where he performs a
` flush operation. And then you wait 10 minutes. And then
` he's got a calibration run. And then you wait 10 minutes.
` The calibration run is where the strontium breakthrough
` testing is performed. And then you have as many patient
` elutions as you want to perform during the course of that
` day, and you wait 10 minutes in between each one of those.
` And then at midnight, this whole sequence needs to be
` repeated. So he says that the calibration and the flush run
` expire, and you have to do it again.
` Klein is -- is clear. He tells you who manages this
` process and who has responsibility for ensuring that this
` process is performed. It is the system. Right?
` This RB -- rubidium infusion system software must
` ensure that the protocol is followed. That each one is
` enabled only after the prerequisites have been completed
` successfully. You need to do the prerequisites, and that's
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` shown here in this excerpt on Slide 12.
` What are the prerequisites? Klein tells us.
` Only after a calibration run with low strontium
` breakthrough has been successfully completed can patient
` elutions be carried out. And then once the daily protocol
` has been completed successfully, patient elutions are
` enabled until the end of the day.
` Who does this? It's the software that does this.
` JUDGE MARSCHALL: Is it possible that the software
`ensures that the protocol is followed by prompting an
`operator to verify that the test result is as desired?
` MR. HAILS: There is no disclosure of it whatsoever.
`It says that the system software ensures that the protocol is
`followed.
` JUDGE MARSCHALL: Well, there's no express
`disclosure either way of how to go to that next step, is
`there, as far as based on the breakthrough test, how one
`proceeds to the next stage of the process?
` MR. HAILS: I think he does. I think he says that
`once the daily protocol has been completed successfully,
`patient elutions are enabled until the end of the day, and he
`does tell you that it happens.
` And there's -- there's no -- there's no discussion
`of any kind of operator verification or -- or input, or
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`operation, or interplay in any way.
` JUDGE MARSCHALL: So I take it it's your position
`that, reading all of these portions of Klein together, it
`teaches that the computer is in charge of proceeding to the
`next step.
` MR. HAILS: Absolutely. 100 percent.
` JUDGE MARSCHALL: All right. And you are not
`relying on inherency; is that correct?
` MR. HAILS: I think it is -- I would think we -- we
`think this disclosure speaks to the test that was identified
`in a case that we give you.
` The question is, a person of ordinary skill in the
`art, reading this material, would they -- I don't want to
`misstate the -- the standard -- would they reasonably infer
`or understand that that material is present. I think that's
`the way that the case speaks to that test, and I think that's
`exactly what's going on here in Klein.
` And Klein is consistent -- we're on Slide 14 --
` Klein is consistent that, again, the software is ensuring
` compliance with the daily protocol that's described.
` Successful breakthrough measurements must be completed.
` And the second excerpt on this Slide 14, the
` software ensures that the daily protocol is followed, and
` you're generating a recording of each elution. We think
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` this is telling somebody of skill in the art it is the
` software that is doing it. It is the computer.
` JUDGE JUNG: All right. Mr. Hails, before you go on
`to the next Slide --
` MR. HAILS: Sure.
` JUDGE JUNG: -- I'm going to read a quote to you
`from page 26 of Klein, and this is from the section entitled
`"Further development of the rubidium elution system".
` And one of the bullet points towards the bottom of
`page 26 is, "A key requirement of this system is to reduce
`radiation exposure to the technologist by automating the
`system and allowing monitoring from a distance." And this is
`the important part. "Although this goal is mostly achieved
`in the prototype system, breakthrough activity measurement
`remained a manual function."
` MR. HAILS: Right.
` JUDGE JUNG: How do you square that with your
`position?
` MR. HAILS: So that -- this reference describes a
`history of the element at the University of Ottawa. We think
`that he is speaking to the prior system. He -- he -- let's
`pull that out.
` He says -- he's speaking to -- there's an
`Alvarez-Diaz reference, and there is -- there are other
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`references that are in there. And he -- I think he is
`speaking to that operation, he is not speaking to his
`operation.
` Let me -- I'd like to pull it up just to make sure I
`understand -- you said page 23; is that right?
` JUDGE JUNG: Page 26. 2-6.
` MR. HAILS: 26. Excuse me.
` We think he is speaking to the prior development
`that is referenced earlier in the material. He's got a
`description of his material -- here we go.
` He's discussing Yano, and he's
` discussing Gennaro, and he's discussing Alvarez-Diaz, and
` he's discussing these other kinds of references.
` He talked about "this system". This system was the
` prototype of the second generation rubidium elution system.
` This is the second generation thing. He says, basically,
` he's keeping that hardware. He's keeping that hardware, and
` he has develop -- he's taken it further, and he's done these
` other kinds of things.
` And I believe that when he's talking about the
` system and how you can only go through the -- the computer,
` and you have to do these kinds of things and run these kinds
` of systems, and then the system is ensuring that that
` protocol is being done, I think he's describing that as an
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`IPR2018-01448 (Patent 9,299,468 B2)
`IPR2018-01449 (Patent 9,299,467 B2)
`IPR2018-01450 (Patent 9,299,468 B2)
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` advance over this prior work, which is the second generation
` system.
` JUDGE JUNG: Okay. Thank you.
` MR. HAILS: All right. Hopefully, I will stay at
`the same place.
` Okay. So let's -- if we can, we'll talk about
` Bracco's counterarguments briefly. They've got three major
` ones that we've excerpted here. I think it probably makes
` sense to start at Slide 16 and deal with them individually.
` Nowhere does Klein ever expressly state that Klein's
` computer prevents patient infusions if a strontium
` breakthrough test result exceeds an allowable limit. We
` think that's wrong.
` Again, the software is doing this. The software
` ensures that the daily protocol test works.
` At the ITC proceedings, Dr. Pelc testified that the
` Klein thesis discloses that the system is locked out until
` you do the calibration run. It's here in black and white.
` He says that -- so the system locks out, and then who
` determines whether patient elutions are being enabled.
` Right? Everything's locked out and then they're enabled.
` He believes it's the operator that -- that enables these
` elutions.
` And we'll go through his flowchart analysis in a
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` moment, but you will not see in the -- in the reference any
` discussion that it is the operator who is -- who is doing
` it.
` This -- this phrase "expressly state". You would
` think that Bracco is basically demanding word-for-word
` correspondence from the disclosure of -- of the reference to
` the claim language.
` We think, again, the test is whether somebody of
` skill in the art would reasonably understand or infer from
` this reference's teaching that every limitation is disclosed
` in that single reference.
` He says it multiple times. It's the system. It's
` the system software.
` JUDGE MARSCHALL: And that's what I was getting at
`before. You acknowledge that the reference does not
`expressly state that a computer is configured to prevent the
`infusion procedure, correct?
` MR. HAILS: We think it does, just in different
`words. Right? We're -- it's the software that enforces that
`protocol, the protocol has those prerequisites built in, and
`the protocol only enables things if the prerequisites are
`met.
` So I respectfully disagree. I think -- you used
` different language. I think he -- I think he teaches -- I
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` think if you're a person of ordinary skill and you read this
` disclosure, you get it. You see it.
` JUDGE MARSCHALL: So you're relying on the express
`disclosure as a whole to establish that this element is
`taught --
` MR. HAILS: Correct.
` JUDGE MARSCHALL: -- even though the words --
` MR. HAILS: Correct.
` JUDGE MARSCHALL: -- are not the same as the claim
`language.
` MR. HAILS: Absolutely. Absolutely.
` JUDGE MARSCHALL: Now, I'm just curious. Looking at
`Claim 1, for example --
` MR. HAILS: Sure.
` JUDGE MARSCHALL: -- of the '467 patent, it talks
`about, "A computer configured to prevent infusion if a
`breakthrough test result exceeds an allowable limit."
` Why wouldn't that language cover an operator
` inputting a breakthrough test result and then a computer
` determining whether to go forward with the infusion
` procedure?
` MR. HAILS: That could happen, I suppose. So we
`didn't -- again, we think that Klein is showing that the
`system actually does it -- does it autonomously.
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` I think that this -- this claim language --
` It's a good point. I mean, the Specification
` actually talks about an off-cart dose calibrator where
` people are keying in readings and doing things. So it's --
` it would be consistent with at least that aspect of the
` disclosure.
` JUDGE MARSCHALL: So even under the means plus
`function limitation in Claim 21, arguably, that would cover
`something in the Specification that would go to the operator
`involvement in that process?
` MR. HAILS: Yeah. If you construe the function to
`be that broadly -- to be broad enough to encompass a computer
`working in tandem with an operator, sure.
` JUDGE MARSCHALL: But you haven't made that
`argument?
` MR. HAILS: That's correct. That's correct.
` Okay. I've forgotten where we were.
` Slide 17. A system must ensure compliance. Right?
` I mean, again, we've gone through that already.
` Okay. The second counterargument that Bracco has
` offered is, they've referred to an experiment that -- that
` Klein conducted to -- to observe breakthrough in a special
` mode, and this requires a little bit of explanation.
` In -- in Klein, Klein doesn't think his claim to
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` fame is a computer lockout. Klein wants to do something
` called a constant activity elution.
` We're dealing with a system where the strontium
` decays over time. It decays over the course of several
` weeks. And the maximum output that -- of radiation that it
` can deliver also will decay.
` What -- and so if you run it in other modes, the
` patient sees different levels of radiation at different
` times, depending on the age of the generator, and Klein
` wants to avoid that.
` Klein does something called a constant activity
` elution. In the perfect world, the radioactivity would
` approximate -- would be a square wave that comes out.
` He -- he accomplishes that by toggling, blending
` radioactive material with pure saline. And so these two
` lines toggle back and forth, and the actual output looks
` like a sawtooth wave sort of around that constant level
` rather than a perfect square wave.
` So now he's running the device in a different mode
` and wants to see, is that going to affect the way the
` generator behaves, and is that going to affect, you know,
` breakthrough events and the rate at which they are
` generated.
` So he runs this experiment, and he purposely pushes
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` a generator past its -- its ordinary state.
` He's -- he's clear that we're talking about a test.
` We're talking about a test that was used in the
` developmental system. This excerpt in the middle of
` Column -- of page 18, "We continue to use the generator on
` the development system past the specifications," he's
` referring to the development system.
` Elsewhere, he refers to this -- this access rights
` issue that I talked about earlier.
` You've got a prompt for a user ID, which is useful
` for avoiding tampering by unauthorized personnel, as well as
` enabling test runs, which were commonly used during the
` development cycle but have no clinical application.
` Bracco has inferred that patient elutions happen in
` this phase. There's absolutely no disclosure of it in
` Klein. Klein is speaking to a development cycle. Klein
` bends over backwards to say, "We are not putting strontium
` into people." And there's no suggestion that -- that this
` test activity has anything to do with a patient infusion
` procedure.
` Okay. Another argument. This is the -- the one
` based upon Dr. Pelc, their expert, talking about this
` Figure 3-15, which we've color coded in our pleading -- or
` our briefing. Maybe it's easiest to go to Slide 20.
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` It's in Bracco's demonstratives. I'm sure they're
` going to go through it.
` Dr. Pelc, in the ITC, basically concluded -- he ran
` through the -- well, first of all, let's maybe orient
` everybody with this drawing.
` There are four flowcharts here. Right? One is
` labeled "Flush" that corresponds to the flush run; one is
` for "Calibration", corresponding to the calibration run; one
` is for "Patient Elutions", the one that we've color coded in
` orange, and that's the only one that matters under the
` claim. Right? We have to prevent patient infusions if the
` strontium breakthrough test goes bad; and then "Test
` Elutions", which are the ones that are used in the
` developmental cycle and have no clinical application.
` Okay. So Dr. Pelc, at the ITC, ran through the one
` that we've color coded in green. And he ran through it, and
` he said, "Hey, you're going to do these things. That means
` you went through these steps. You flushed the generator and
` you flushed the lines. There was no failure of the pump.
` There was no failure of the dose calibrator. The dose
` calibrator gave you numbers," and that's, in his view, what
` a successful run means. You do this, and you can go on to
` do patient elutions. That's his conclusion.
` You get to the end, and regardless of outcome -- you
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` could have the most strontium in the world. Right? You
` could kill somebody the day you infuse it into somebody, he
` thinks that that's -- that the responsibility for -- for
` determining whether you do a patient elution or not falls on
` the operator.
` There is no disclosure anywhere in Klein that says
` the operator bears that responsibility, and it runs against
` all of the stuff that we've talked about already with the
` system software ensuring that the daily protocol is being
` performed. Right?
` How does Klein define success? Only after
` calibration run with low strontium breakthrough has been
` successfully completed can patient elutions be carried out.
` That's on Slide 20.
`
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