`
`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
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`INFORMATION
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`":1-:'-.i=:'i‘;"
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`Bracco EX. 2007
`
`Jubilant V. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2007
`Jubilant v. Bracco
`IPR2018-01449
`
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`UNITED STATES OF AMERICA
`
`Page673
`
`BEFORE THE
`
`INTERNATIONAL TRADE COMMISSION
`
` IN THE MATTER OF:
`
`: Investigation Number
`
`CERTAIN STRONTIUM-RUBIDIUM
`
`: 337-TA-lllo
`
`International Trade Commission.
`
`
`
`RADIOISOTOPE INFUSION SYSTEMS AND
`
`COMPONENTS THEREOF INCLUDING
`
`GENERATORS
`
`HEARING - VOLUME IV
`
`April 16, 2019
`
`Courtroom C
`
`U.S. International Trade
`
`Commission
`
`
`500 E Street, S.W.
`
`Washington, D.C.
`
`The Hearing commenced, pursuant
`
`to notice of the Judge, at
`
`9:03 a.m., before the Honorable CLARK S. CHENEY,
`
`Administrative Law Judge for the United States
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`reporter. But
`
`I would like to move —— jointly move the
`
`Page682
`
`admission of the exhibits that we are sending to the court
`
`reporter that were discussed —— discussed on the record
`
`
`from April 15th, 2019.
`
`
`JUDGE CHENEY:
`
`I presume c0unsel for complainant
`
`and staff understand the list of exhibits that Mr. Hails
`
`has represented and is there any objection to the admission
`
`of those exhibits?
`
`MR. DAVIS: No, Your Honor.
`
`MR. KOO:
`
`No, Your Honor.
`
`JUDGE CHENEY:
`
`The exhibits identified by
`
`Mr. Hails will be admitted to the record.
`
`MR. HOFFMAN: Your Honor, Mr. Hails is sitting
`
`in front of me.
`
`I‘m Mr. Hoffman.
`
`JUDGE CHENEY:
`
`I'm sorry. Mr. Hoffman.
`
`Any other housekeeping matters before we
`
`resume
`
`with Dr. Stone? Okay. Hearing none, we'll ask Dr. Stone
`
`to return to the stand.
`
`As you‘re coming to the stand,
`
`Dr. Stone, I‘ll remind you you're still under the same
`
`obligation to tell the truth under penalty of perjury.
`
`testified as follows:
`
`WhereupOn,
`
`DR. ROBERT STONE,
`
`was called as a witness by oeunsel for Respondents, and
`
`having been previously duly sworn, was examined and
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`THE WITNESS:
`
`Thank you, Your Honor.
`
`Page 683
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`JUDGE CHENEY: Mr. Hails, who has spent all
`
`evening talking slowly and clearly in the mirror so that
`
`today we'll just have a nice relaxed transcript.
`
`MR. HAILS: We'll see. Yes, sir.
`
`DIRECT EXAMINATION
`
`BY MR. HAILS:
`
`Q
`
`Dr. Stone, before we broke we were talking about
`
`shielding design.
`
`Do you recall that?
`
`A
`
`Q
`
`Yes.
`
`Let's pull up RX—357, page 10, if yOu can.
`
`Do
`
`believe that is for the waste container and here we have
`
`you recognize this, Dr. Stone?
`
`A
`
`Q
`
`Yes,
`
`I do.
`
`Do you see any shielding compartments
`
`illustrated in this photograph?
`
`A
`
`Q
`
`A
`
`Yes,
`
`I do.
`
`First of all, what does this picture illustrate?
`
`This is a picture of the interior of the cabinet
`
`of the CardioGen 82 or the Model 510 as it's called.
`
`Q
`
`The Model 510. Okay.
`
`Do you see any shielding
`
`compartments in this design?
`
`A
`
`Q
`
`A
`
`I do.
`
`Would you point
`
`them out for us?
`
`In the back is a shielding compartment.
`
`I
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`the shielding compartment for the generator.
`
`Page 684
`
`Q
`
`And Ricky, can we blow up that sticker in the
`
`
`middle center on that first.
`
`All right.
`
`Do you see the sticker for the
`
`generator shield?
`
`element 111 in this diagram, 121 in this diagram, and 12?
`
`A
`
`Q
`
`I do.
`
`Okay.
`
`You can back out of that. All right.
`
`So
`
`which way do the openings face on the shielding?
`
`A
`
`Q
`
`
`They face vertically upward.
`
`Let's switch over to RX—103 at page 4.
`
`Can we
`
`rotate that so the letters all line up.
`
`Thank you.
`
`Do you recognize this as the Tate application
`
`that you've been discussing?
`
`A
`
`Q
`
`I do.
`
`Okay.
`
`Do you see any shielding containers --
`
`sorry, shielding compartments in this —— illustrated in
`
`this figure?
`
`A
`
`Q
`
`A
`
`Yes,
`
`I do.
`
`Can yOu point
`
`them out for us.
`
`Yes. Here we have,
`
`I believe it's a shielding
`
`compartment for the source. Here we have the shielding
`
`
`compartment for the onboard dose calibrator, and I believe
`
`this is a shielding compartment for the waste bottle.
`
`Q
`
`And just for the record, Dr. Stone pointed to
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`in this diagram.
`
`PagefiSS
`
`Dr. Stone, do you recognize this as a top view
`
`of the Tate cart?
`
`A
`
`Q
`
`Yes,
`
`I do.
`
`And which way do the openings of these shielding
`
`
`compartments face?
`
`A
`
`Q
`
`They face vertically upward.
`
`Can you explain why do people build shielding
`
`compartments with openings that face vertically upward?
`
`A
`
`Yes.
`
`As one is approaching a device,
`
`the
`
`shielding can be complete and enclosed without access to
`
`the device if the shielding compartments face vertically
`
`Do you see that?
`
`upward.
`
`So the shielding is providing adequate protection
`
`for the thorax of a person unless —— and the only way they
`
`could get exposed to the thorax is if they leaned over that
`
`source of radioactive material.
`
`So they don't have to
`
`expose themselves to radiation as they approach the devices
`
`because it's fully enclosed with openings facing vertically
`
`upward and radiation only going upward even if the lid were
`
`open.
`
`Can we return to the PowerPoint.
`
`Okay. Before we broke, we were talking about
`
`this element shown here on slide 128 at the bottom,
`
`the
`
`first door element.
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`Q
`
`Okay. And this claim element says that the
`
`Pag3686
`
`first dOor is configured to provide access to the shielding
`
`compartment and to close over that first opening.
`
`Do you see that?
`
`I do.
`
`Did you see any teachings of this subject matter
`
`A
`
`Q
`
`in the prior art?
`
`A
`
`Yes.
`
`In Klein,
`
`the generator was placed in the
`
`cart and surrounded by lead rings to provide maximum
`
`radiation shielding.
`
`The opening faced vertically upward
`
`in that configuration. Similarly in Tate,
`
`the radioactive
`
`source was inserted into a well and had an opening which
`
`faced vertically upward.
`
`Q
`
`A
`
`Can you show us the door in the Tate design?
`
`In Tate, we have a door which closes over the
`
`source of radioisotope.
`
`
`For the record, we‘re looking at figure 4A from
`
`If someone applied a door to a shielding
`
`Q
`
`A
`
`Q
`
`Tate.
`
`And did you point
`
`to element 684 in that drawing?
`
`I did.
`
`Are doors conventional structures for shielding
`
`design in the mid 2000?
`
`A
`
`Doors are conventional structures for shielding
`
`in my entire history of looking at radioisotopes and
`
`radioactive sources.
`
`They are very common.
`
`Q
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`structure,
`
`for example,
`
`in the Klein design, would it be
`
`Page 68’?
`
`
`accessible via the opening through the exterior shell 0:
`
`the compartment?
`
`A
`
`Q
`
`Yes, it would.
`
`Move forward, please.
`
`JUDGE CHENEY: Mr. Hails, you tend to be doing
`
`this with microphone.
`
`I need you to be doing this with
`
`your microphone. There you go.
`
`BY MR. HAILS:
`
`Q
`
`Okay. We are at slide 129 in the presentation.
`
`Talking about claim 1. And claim 1 refers to a second
`
`shielding compartment.
`
`Do you see that in the slide?
`
`I do.
`
`A
`
`Q
`
`On the third line it talks abou: that the second
`
`And that opening, does Klein teach that that
`
`
`
`shielding compartment is for the waste bottle.
`
`Do you see that in claim 1?
`
`Yes.
`
`Does the prior art claim teach a second
`
`A
`
`Q
`
`shielding compartment for a waste bottle?
`
`A
`
`Q
`
`A
`
`Yes, it does.
`
`Please explain.
`
`Klein had a waste bottle on the top shelf that
`
`was in a shielded container and it had an opening facing
`
`vertically upward.
`
`Q
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`opening is one through which a waste bottle can be inserted
`
`Page 688
`
`into or removed from the shielding compartment?
`
`A
`
`Q
`
`Yes, he does.
`
`All right. Let's move forward, please.
`
`I
`
`should note for the record that slide 129 has an excerpt
`
`from figure 2—3 of the Klein thesis.
`
`The second door —e
`
`I‘m sorry,
`
`the next element
`
`is a second door that is configured to provide access to
`
`the second shielding compartment and to close over the
`
`second opening. Did you see teachings of this subject
`
`matter in the prior art?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Please explain.
`
`As Klein describes,
`
`a waste container was
`
`a door here that opened over this area and that‘s
`
`mounted on the top shelf inside a lead container with a
`
`lid. That lid door sliding whatever,
`
`those are very common
`
`in the art-
`
`Q
`
`Okay.
`
`The claim talks about that the second
`
`door is accessible by the opening through the top surface
`
`of the exterior shell of the cart. Did you see that
`
`subject matter talked about
`
`in the prior art?
`
`A
`
`Q
`
`A
`
`Yes,
`
`I did-
`
`Please explain.
`
`I‘m sorry.
`
`We previously showed that there was
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`accessible via the top shelf of the -— the top surface of
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`Page689
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`the cart.
`
`Q
`
`Okay. All right.
`
`So the slide 129 also lists a
`
`wherein clause from claim 1 saying that the first opening,
`
`which is the one corresponding to the generator shield,
`
`is
`
`located at a lower elevation than the second opening, which
`
`is the one corresponding to the waste bottle.
`
`Will you please remind the Court how does the
`
`prior art teach that subject matter?
`
`A
`
`
`first 0: all, it would be obvious to relocate the generator
`
`The prior art teaches that subject in that,
`
`and the shielding to a lower elevation for ergonomic
`
`
`
`SOUICES .
`
`
`purposes as we've discussed as taught by Chaffin, which
`
`would be well—known to a person who is designing medical
`
`devices and designing any industrial device.
`
`Q
`
`And Chaffin,
`
`for the record,
`
`is RX-96. Let's
`
`move forward, please.
`
`We are at slide 130 and the claim is talking
`
`about a radioactivity detector. Does the prior art teach a
`
`radioactivity detector?
`
`A
`
`Q
`
`A
`
`Yes, it does.
`
`Please explain.
`
`We have a radioactivity connector at
`
`activity counter in the Klein thesis as well as
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`Q
`
`For the record, slide 130 shows an excerpt from
`
`Page690
`
`Klein figure 2—2 on page 29.
`
`Is the radioactivity detector
`
`that's caught by the prior art,
`
`is it positioned to measure
`
`radioactivity of a rubidium radioactive eluant that flows
`
`through an eluant tubing line?
`
`A
`
`Yes, it does.
`
`The tubing is positioned to go
`
`under the radioactivity detector and it counts it while the
`
`tubing -— the fluid is flowing through.
`
`
`
`Q
`
`Is the eluate tubing line in fluid communication
`
`with an outlet tubing port of the strontium—rubidium
`
`radioisotope generator?
`
`A
`
`Yes, it is.
`
`It's shown here this is the outlet
`
`and it‘s in fluid communication.
`
`
`
`Q
`
`LGZ'S move forward, please-
`
`We are on slide 131
`
`
`
`of the presentation.
`
`Claim 1 talks about a shielded well on board the
`
`cart configured to receive an eluate reservoir.
`
`Please
`
`explain how does the prior art teach this subject matter?
`
`A
`
`Well,
`
`the Klein thesis has indeed a shielded
`
`well
`
`in the dose calibrator and it has the eluate reservoir
`
`
`
`nothing inventive in that step.
`
`
`
`in the shielded well while a dose is pumped into it.
`
`He
`
`doesn‘t have it on board the cart, but as we stated
`
`previously, it is obvious to relocate the dose calibrator.
`
`It was done by Tate.
`
`It‘s done by Medrad. There is
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`
`Q
`
`Again for the record, slide 131 shows a split
`
`Page 691
`
`screen,
`
`I guess, with both figure 2-3 and figure 2—2
`
`from
`
`the Klein thesis. Next part of this shielded well element
`
`says that the eluate reservoir is configured to receive a
`
`test sample.
`
`Do you see that?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Does the prior art teach that subject matter?
`
`Yes, it does.
`
`The computer configures the flow
`
`path.
`
`So it goes out to the patient line, which itself is
`
`now inserted into the eluate reservoir so that the eluate
`
`reservoir can receive a test sample.
`
`Q
`
`Let's move forward, please. Claim 1 also refers
`
`to the computer of the system and lists a variety of
`
`
`features.
`
`One is to provide a stop button on the
`
`touchscreen display. Did you see a stop button taught by
`
`the prior art?
`
`A
`
`As we've seen before,
`
`the stop button is there
`
`for all elutions.
`
`Q
`
`For the record, slide 132 shows a screenshot
`
`taken from page 64 of the Klein thesis.
`
`Does the prior art teach that that stop button
`
`aborts a function of the infusion system in response to a
`
`user input that activates the stop button?
`
`Let's move forward, please. Claim 1 says that
`
`That's correct.
`
`A
`
`Q
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`the computer is configured to pump saline frOm a saline
`
`Pag6692
`
`reservoir. Does the prior art teach this subject matter?
`
`A
`
`Q
`
`A
`
`Yes, it does.
`
`Please explain-
`
`A computer controls a peristaltic pump, which
`
`do it on the screen up here.
`
`takes saline from the saline reservoir.
`
`Q
`
`A
`
`All right.
`
`Please continue.
`
`It then pumps it through the generator valve
`
`into the inlet port of the generator and the eluate is
`
`pumped out of the outlet point —— sorry,
`
`through the outlet
`
`tubing port of the generator.
`
`Q
`
`Okay.
`
`So this —- for the record, slide 133
`
`again shows an excerpt
`
`from figure 2-2 of the Klein thesis
`
`and Dr. Stone was referring to the peristaltic pump that‘s
`
`illustrated in that diagram.
`
`Okay.
`
`The claim says that the saline reservoir
`
`
`has to be positioned outside the interior space of the
`
`cabinet structure. Does the prior art teach that subject
`
`matter?
`
`A
`
`Q
`
`A
`
`Yes, it does.
`
`Please show us.
`
`The peristaltic pump *— sorry,
`
`the saline
`
`reservoir is here outside the cart.
`
`Q
`
`You‘re pointing to our own screen. Why don't we
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`A
`
`Thank you.
`
`I'm sorry. Here we have the saline
`
`Page 693
`
`reservoir outside the cart.
`
`teach this subject matter?
`
`Q
`
`And for the record, Dr. Stone was pointing to
`
`
`figure 2—3
`
`from the Klein cart and the annotation that we
`
`
`provided on slide 133 for the saline bag.
`
`Okay. Does the pump —— sorry, does the computer
`
`pump saline into the strontium-rubidium radioisotope
`
`generator through an inlet tubing port?
`
`A
`
`Yes, it does. Here is the inlet tubing port we
`
`discussed previously.
`
`Q
`
`And does that process generate the rubidium
`
`radioactive eluate that is discharged through the outlet
`
`tubing port?
`
`A
`
`Q
`
`Yes, it does.
`
`Please go back.
`
`Go back, please, one more.
`
`Just show us the outlet tubing port on slide 133.
`
`A
`
`Q
`
`
`I‘m sorry. Here we have the outlet tubing port.
`
`Very good. Let's move forward, please.
`
`All right.
`
`We are on slide 134 and we have an
`
`excerpt
`
`from figure 2—2
`
`from the Klein thesis.
`
`The claim
`
`says that the computer of the infusion system fills the
`
`eluate reservoir in the shielded well on board the cart
`
`with a test sample of the rubidium radioactive eluate.
`
`Please remind the Court, how does the prior art
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`A
`
`Again,
`
`this is a block diagram from the Klein
`
`Pagefi94
`
`thesis.
`
`We have the eluate reservoir in the shielded well
`
`with pumping and filling of that eluate reservoir is
`
`controlled by the computer configuring the valves and the
`
`pump in order to do that.
`
`And it doesn‘t
`
`to on board the
`
`cart, but as we say, it's obvious to relocate the cart for
`
`reasons we've discussed with regard to the weight of the
`
`cart and the movement.
`
`Q
`
`Okay. And on this drawing here,
`
`figure 2—2
`
`
`from
`
`the Klein thesis, you're pointing to the dose calibrator
`
`color coded in blue;
`
`is that correct?
`
`A
`
`Q
`
`That is correct.
`
`All right.
`
`Do you see that box with the little
`
`snowman—looking icon inside?
`
`A
`
`Q
`
`A
`
`Yes.
`
`What is that?
`
`The box with the little snowman is the shielded
`
`the activity when the sample is first placed in the well.
`
`well with the eluate reservoir inside.
`
`Q
`
`Move forward, please. Claim 1 says that the
`
`computer is configured to determine a strontium
`
`breakthrough test result on the test sample.
`
`Please remind
`
`the Court, how does that process occur in the prior art?
`
`A
`
`Well, we‘ve discussed the Klein thesis that the
`
`strontium breakthrough test is termed by first measuring
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`The computer then waits 30 minutes and takes another
`
`Page 695
`
`reading and computes the strontium breakthrough from the
`
`formula shown below.
`
`Q
`
`And does that process operate On a test sample
`
`that is filled into an eluate reservoir in a shielded well?
`
`A
`
`Q
`
`Yes, it does.
`
`We've discussed here on board the cart, off—cart
`
`analysis already, correct?
`
`A
`
`That‘s correct. All
`
`the system components were
`
`calibration run and a successful breakthrough measurement
`
`there in Klein.
`
`We are just talking about the
`
`rearrangement for a commercial product.
`
`Q
`
`All right. Let's go through the while clause in
`
`this element. Does that process occur while the eluate
`
`reservoir remains in the shielded well?
`
`A
`
`Q
`
`Yes, it does.
`
`Let's move forward, please. Claim 1 further
`
`states that the computer is configured to not allow a
`
`patient infusion if the strontium breakthrough test result
`
`is greater than or equal
`
`to an allowed limit.
`
`Please remind the Court, how does the prior art
`
`teach the subject matter?
`
`A
`
`The Klein thesis states specifically that the
`
`computer disables patient elution —— sorry,
`
`that the
`
`computer does not enable patient elutions unless a
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`are completed. That's done daily.
`
`The amount is
`
`determined by the Health Canada guidelines for the
`
`strontium breakthrough level that's part of the daily
`
`protocol and the system software ensures that the protocol
`
`is followed;
`
`that is, each run is enabled only after the
`
`prerequisites have been completed successfully.
`
`Q
`
`For the record, we are on slide 136 and the
`
`excerpts shown are from pages 39, 43 and 54 of the Klein
`
`thesis. Let‘s move forward, please.
`
`Okay. Claim 1 talks about a shielding for a
`
`generator. Claim 2 says that the infusion system further
`
`comprises the strontium—rubidium radioisotope generator in
`
`the first two compartments. Did you see a
`
`strontium—rubidium radioisotope generator taught by the
`
`prior art?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Can you point it out
`
`to us?
`
`Here we have the strontium—rubidium generator in
`
`slide 37.
`
`the interior space of the cabinet shown how we had proposed
`
`that it was obvious to move it, but it was
`
`in the interior
`
`previously.
`
`Q
`
`All right. And so for the record, Dr. Stone is
`
`pointing, again,
`
`I
`
`think it's to figure 2-3 of the Klein
`
`thesis.
`
`So let‘s move forward, please. We are still on
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`Claim 2 says that there is an eluate reservoir
`
`Page 69?
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`located in the shielded well on board the cart and in fluid
`
`communication with the eluate tubing line. Did you see
`
`that subject matter taught by the prior art?
`
`
`
`to
`
`A
`
`Q
`
`A
`
`Yes.
`
`Please explain.
`
`We've talked about the eluate reservoir in the
`
`shielded well previously.
`
`The on board the cart we've also
`
`talked about that it's obvious to relocate that as it's
`
`
`done in the prior art and it's in fluid communication with
`
`the eluate tubing line as shown in the hot pink tracing
`
`that we have here.
`
`Q
`
`For the record, we are on slide 137 of this
`
`presentation and the hot pink he was referring to was taken
`
`from slide -- I‘m sorry,
`
`from figure 2-2 of the Klein
`
`thesis.
`
`All right. Let‘s move forward.
`
`So now we are
`
`at claim 3.
`
`We are on slide 138. Claim 3 says that the
`
`cabinet structure has a lowermost portion and the platform
`
`has a lower surface. Did you see that subject matter
`
`taught by the prior art?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Walk us through it, please.
`
`Well, we've talked about how it would be obvious
`
`to relocate the generator and the shielding compartment
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`a lower elevation.
`
`Ergonomics is taught by Chaffin.
`
`If I
`
`Pag6693
`
`look at this proposed concept here that would happen and
`
`compare it with a standard laboratory countertop, which is
`
`normally found at a height of 30 to 36 inches,
`
`so if I
`
`
`compare that to the opening that we have here in the first
`
`generator,
`
`that, by that comparison, my eye is easily
`
`determined to be nominally between one and two feet.
`
`Q
`
`Let me stop you right there. Right now we are
`
`talking about part one of this claim and it says that the
`
`cabinet structure has a lowermost portion.
`
`Let's talk about
`
`the cabinet structure just to
`
`make sure the record is clear.
`
`Do you see he a cabinet
`
`structure in this picture here on —— I
`
`think this is figure
`
`2—3?
`
`The claim talks about the first
`
`Yes, we have a cabinet structure as shown here.
`
`Does it have a lowermost portion?
`
`It does.
`
`Did you see a platform in this figure 2—3?
`
`There is a platform here at the base of the
`
`And did that platform have a lower surface?
`
`Yes, it does.
`
`All right.
`
`So now let's talk about
`
`the next
`
`A
`
`Q
`
`elements.
`
`You were talking about
`
`the shielding and let's
`
`walk through the claim.
`
`
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`opening, which refers back to the shielding compartment of
`
`Page 699
`
`the generator and that must be at a first elevation.
`
`So with the modifications that you've identified
`
`here using the Chaffin teachings, where is the —— what is
`
`
`the elevation of the first opening?
`
`A
`
`Q
`
`Here is the first opening. That's where it‘s
`
`Okay.
`
`So let‘s go to the next element. And
`
`nominally between 30 and 36 inches for ergonomics for a
`
`that refers to a second Opening, which refers back to the
`
`shielding compartment for the waste bottle. Applying these
`
`teachings, do you see that the second opening for the waste
`
`bottle would be at a second elevation?
`
`A
`
`Yes.
`
`In the original location that's shown in
`
`Klein's thesis, we had the waste container located there at
`
`that second elevation.
`
`Q
`
`All right. And then the next —— sorry,
`
`the next
`
`
`element says that the first elevation, which again refers
`
`to the shielding compartment,
`
`is between approximately one
`
`foot and approximately two feet with respect to the
`
`lowermost portion of the cabinet structure.
`
`Okay.
`
`Please walk us through your analysis of
`
`this element.
`
`A
`
`All right.
`
`Thank you. Again, using the
`
`standard height of a laboratory countertop positioned
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`workspace, using that as a reference of nominally 36
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`Page 700
`
`inches,
`
`this first opening is halfway through. That would
`
`be between one and two feet.
`
`Q
`
`And do you recall looking at the shielding
`
`generator this morning for the CardioGen 510?
`
`A
`
`Q
`
`I do.
`
`Would you agree with me that the shielding
`
`
`compartment 0: that structure also was at the bottom of
`
`that cart?
`
`A
`
`Q
`
`Yes, it is.
`
`Let‘s move forward please to the next element.
`
`wherein clause, wherein the first shielding compartment
`
`So the next element says that the second elevation is
`
`between approximately two feet and approximately three feet
`
`with respect to the lower surface of the platform.
`
`Please
`
`explain your analysis of this element.
`
`A
`
`The Klein thesis had the shielded waste
`
`container with its upwardly facing —— sorry, vertically
`
`upward facing opening was on that shelf.
`
`And as you can
`
`see in comparison with the countertop,
`
`that's between two
`
`and three feet with respect to the lower surface of the
`
`platform.
`
`Q
`
`Let‘s move forward, please.
`
`We are at slide 139
`
`and we are talking about claim 4 of the '869 patent.
`
`Claim 4 says that the infusion system has a
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`comprises two tubing passageways formed in a perimeter
`
`PageTOI
`
`Surface of the first opening.
`
`Let's talk about
`
`tubing passageways first.
`
`In
`
`the Klein thesis, how many tubing passageways go in and out
`
`of the generator?
`
`A
`
`Well, he has two tubing passageways because we
`
`have to have saline going in.
`
`I'm sorry.
`
`The system has
`
`saline going in and has the strontium—rubidium eluate
`
`coming out.
`
`Q
`
`
`Did you see teachings or a shielding compartment
`
`
`with tubing passageways formed in a perimeter surface of an
`
`opening of the shielding compartment?
`
`A
`
`We saw that in the —— the tubing passageways
`
`were formed in the perimeter surface on the Tate system.
`
`Q
`
`
`
`We have an excerpt here From figure 6—H 0“ Tate
`
`on page 119.
`
`Show me
`
`the tubing passageway.
`
`A
`
`We have a tubing passageway here formed in the
`
`perimeter of the shielded well.
`
`Q
`
`And the shielded well,
`
`is that element 111 in
`
`in two?
`
`this drawing?
`
`A
`
`Q
`
`Yes.
`
`Okay. There is only one in the Tate system.
`
`But there are two tubing —— that's tubing in the Klein
`
`system. Why don't you explain why is that —— why is it
`
`obvious to put
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`A
`
`Well,
`
`in the Tate system, using FDG, one merely
`
`Page 702
`
`needs a single tube in order to withdraw eluate —* or in
`
`order to withdraw the radioisotope source —— sample from
`
`the source.
`
`In the strontium—rubidium isotope generator,
`
`you need two tubes; one to go in with the saline and one to
`
`bring the eluate out.
`
`Q
`
`Do you believe it's obvious to apply the
`
`teachings of Tate and to add a second tubing passageway,
`
`one for the other tube?
`
`A
`
`One would have tubing passageways for each of
`
`the tubings.
`
`In order to do that,
`
`that would be obvious.
`
`It would be the standard thing to do.
`
`I do.
`
`Q
`
`_
`
`On this slide 139, you color coded a tube 210 in
`
`pink;
`
`is that correct?
`
`A
`
`Q
`
`Yes.
`
`Okay.
`
`
`The opening in the perimeter surface 0:
`
`this shielded well, does it pinch that tube?
`
`A
`
`No.
`
`It certainly would not be obviOus to have
`
`anything that would pinch the tube if I need to have flow
`
`through that tube.
`
`Q
`
`A
`
`Q
`
`Does that opening crush the tube?
`
`No,
`
`it does not.
`
`And you have this element 684 with the red halo
`
`around it on slide 139.
`
`Do you see that?
`
`A
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`Q
`
`And remind the Court, what is that?
`
`Page 703
`
`A
`
`That is the source of
`
`rubidium—82 in a shielded
`
`container.
`
`Q
`
`A
`
`Q
`
`I'm sorry.
`
`So 684 ——
`
`Actually, not rubidium—82.
`
`Of FDG.
`
`We have a shielded well, right, at 111? Please
`
`Did you see teachings of that subject matter in
`
`look at the screen.
`
`And what is this guy?
`
`A
`
`I‘m sorry. That is a door over the
`
`vial of FDG.
`
`Q
`
`All right.
`
`For the record,
`
`I was pointing to
`
`684 as "this guy."
`
`80 that door is closed in the shielded
`
`well. Would you agree?
`
`A
`
`Q
`
`That's correct.
`
`All right. Does Tate disclose that that door
`
`crushes or pinches that tube when that door is closed?
`
`A
`
`Q
`
`No.
`
`Let‘s move forward, please. All right.
`
`We are
`
`now on slide 140 and we are talking about claim 5 of the
`
`‘869 patent.
`
`Claim 5 says the opening through the exterior
`
`shell is configured to provide -- that is configured to
`
`provide access to the strontium—rubidium radioisotope
`
`generator within the interior space of the cabinet
`
`structure is through the front side of the exterior shell.
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`the prior art?
`
`A
`
`Q
`
`A
`
`Q
`
`I do.
`
`Show me the front side.
`I:
`Here is the _ront side.
`
`
`
`And do you see an opening in the front side?
`
`There is indeed an opening in the front side.
`
`
`And would that front side provide acce5s to the
`
`generator?
`
`A
`
`Q
`
`Yes, it does.
`
`That was slide 140. Let‘s move to the next
`
`slide, please.
`
`So now we are at slide 141 still talking
`
`about
`
`the '869 patent. We are now at claim 8.
`
`Claim 8 says wherein the infusion system is
`
`The excerpt on this slide 141 is
`
`configured to determine the strontium breakthrough test
`
`result on the test sample at leas: once a day.
`
`Please
`
`
`
`explain how does this prior art teach this subject matter?
`
`A
`
`Klein clearly describes that his system ensures
`
`compliance with the daily protocol prescribed in the
`
`previous chapter, a flush followed by a calibration run and
`
`successful breakthrough measurement must be completed in
`
`order to enable patient elutions for the remainder of the
`
`day.
`
`So at midnight,
`
`that daily protocol completed is
`
`cleared and the daily protocol chart has to be completed in
`
`order to enable patient elutions.
`
`Q
`
`All right.
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`taken from page 139 of the Klein thesis.
`
`We also have an
`
`Page 705
`
`excerpt showing figure 2-1 from the Klein thesis. Where in
`
`this daily protocol are the patient elution runs?
`
`A
`
`Patient elution runs are here after the
`
`assemble them, how to check their correct functioning.
`
`completion of the calibration run-
`
`Q
`
`I was going to ask where in the daily protocol
`
`is the calibration run?
`
`A
`
`Q
`
`
`It‘s after the daily flush.
`
`And you said that the calibration run must
`
`achieve a successful breakthrough measurement
`
`in order to
`
`enable the patient elutions;
`
`is that correct?
`
`A
`
`Q
`
`That's correct.
`
`Let's move forward, please.
`
`So we are at slide
`
`142.
`
`And we‘ll talk about claim 14 of the '869 patent.
`
`Claim 14 talks about various functions of the computer of
`
`the infusion system.
`
`
`The first one is to track a volume of
`
`the saline remaining in the saline reservoir.
`
`Please explain how does the prior art teach this
`
`subject matter?
`
`A
`
`Well, saline is a consumable for the system.
`
`The international standard for user interfaces for medical
`
`devices calls for the user to be aware of the use of the
`
`correct consumable,
`
`the remaining amount of them, whether
`
`accessories might be used with the medical device, how to
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`Saline is indeed a consumable.
`
`The user is made
`
`PagBTOG
`
`aware of that through the user interface as described and
`
`taught by this standard.
`
`Q
`
`Okay.
`
`For
`
`the record, on this slide 141 we
`
`haven excerpt
`
`from RX—ll4 at page 63. All right.
`
`And do
`
`you see -- did you see a description of tracking saline in
`
`the Medrad documentation?
`
`A
`
`Q
`
`Yes, we did.
`
`We'll get
`
`to that in a moment. Did you see a
`
`description of tracking saline in the Tate patent
`
`application?
`
`A
`
`Q
`
`Yes.
`
`All right. Let's move forward. Claim 14 also
`
`talks about that the computer is configured to alert the
`
`user via the touchscreen display when the volume of the
`
`saline remaining in the saline reservoir is below a
`
`predetermined volume threshold. Why don't you walk us
`
`through the subject matter.
`
`A
`
`Yes.
`
`As we stated previously,
`
`I believe that‘s
`
`covered by the international standard calling for the user
`
`to be made aware of the correct usage and how to assemble
`
` them, how to check their correct functioning.
`
`to that in a moment. Let‘s move
`
`And it's
`
`also provided to Medrad where they provide an alert when
`
`the remaining saline is low.
`
`Q
`
`We'll get
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`forward, please.
`
`Can we move forward.
`
`Page 707
`
`A
`
`Q
`
`Yes.
`
`Okay-
`
`So now we are on slide 144.
`
`We were
`
`
`talking about claim 24. Claim 24 first recites a hanger
`
`configured to hold the saline reservoir at an elevation
`
`
`above the top surface of the exterior shell.
`
`Does the prior art teach this subject matter?
`
`A
`
`Well,
`
`the first portion of this element,
`
`the
`
`hanger that hangs the saline bag is taught both in Klein
`
`and in the Tate patent application; however, it's clearly
`
`disclosed in the CardioGen Model 510.
`
`Medrad.
`
`Q
`
`In your experience,
`
`is it common or is it an
`
`uncommon configuration to hang saline at high elevations on
`
`medical devices?
`
`A
`
`It‘s hung at a high elevation.
`
`It makes it
`
`clearly visible from across the room.
`
`Q
`
`Let's move forward, please.
`
`The next element is
`
`a handle that‘s configured for the user to grasp