Date: April 16, 2019
`
`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL
`INFORMATION
`
`
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`EXHIBIT
`
`Bracco Ex. 2007
`Jubilant v. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2007
`Jubilant v. Bracco
`IPR2018-01449
`
`
`
`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL
`INFORMATION
`
`
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`EXHIBIT
`
`Bracco Ex. 2007
`Jubilant v. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2007
`Jubilant v. Bracco
`IPR2018-01449
`
`
`
`THIS DOCUMENTCONTAINS CONFIDENTIAL INFORMATION
`
`UNITED STATES OF AMERICA
`
`BEFORE THE
`
`INTERNATIONAL TRADE COMMISSION
`
`Page 673
`
` IN THE MATTER OF:
`
`: Investigation Number
`
`CERTAIN STRONTIUM-RUBIDIUM
`
`: 337-TA-1110
`
`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 BE 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
`
`202-347-3700
`
`Ace-Federal Reporters,Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`reporter. But
`
`I would like to move -- jointly move the
`
`admission of the exhibits that we are sending to the court
`
`reporter that were discussed -- discussed on the record
`
`Page 682
`
`
`from April 15th, 2019.
`
`
`JUDGE CHENEY:
`
`I presume counsel 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.
`
`testified as follows:
`
`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.
`
`Whereupon,
`
`DR. ROBERT STONE,
`
`was called as a witness by counsel for Respondents, and
`
`having been previously duly sworn, was examined and
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`THE WITNESS:
`
`Thank you, Your Honor.
`
`JUDGE CHENEY: Mr. Hails, who has spent all
`
`Page 683
`
`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:
`
`believe that is for the waste container and here we have
`
`0
`
`Dr. Stone, before we broke we were talking about
`
`shielding design.
`
`Do you recall that?
`
`A
`
`QO
`
`Yes.
`
`Let's pull up RX-357, page 10, if you can.
`
`Do
`
`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
`
`QO
`
`A
`
`I do.
`
`Would you point
`
`them out for us?
`
`In the back is a shielding compartment.
`
`I
`
`202-347-3700
`
`Ace-Federal Reporters,Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 684
`
`the shielding compartment for the generator.
`
`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?
`
`A
`
`Q
`
`I do.
`
`Okay.
`
`You can back out of that. All right.
`
`So
`
`element 111 in this diagram, 121 in this diagram, and 127
`
`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
`
`deo’,
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`in this diagram.
`
`Page 685
`
`Do you see that?
`
`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
`
`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.
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Q
`
`Okay. And this claim element says that the
`
`first door is configured to provide access to the shielding
`
`compartment and to close over that first opening.
`
`Page 686
`
`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.
`
`QO
`
`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
`
`Tate.
`
`And did you point
`
`to element 684 in that drawing?
`
`If someone applied a door to a shielding
`
`Q
`
`A
`
`Q
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`structure,
`
`for example,
`
`in the Klein design, would it be
`
`
`accessible via the opening through the exterior shell of
`
`Page 687
`
`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 des
`
`A
`
`0
`
`On the third line it talks about 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.
`
`Dees the prior art claim teach a second
`
`A
`
`Q
`
`shielding compartment for a waste bottle?
`
`A
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters,Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENTCONTAINS CONFIDENTIAL INFORMATION
`
`opening is one through which a waste bottle can be inserted
`
`into or removed from the shielding compartment?
`
`Page 688
`
`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 -- 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
`
`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 door here that opened over this area and that's
`
`A
`
`QO
`
`A
`
`Yes,
`
`I did.
`
`Please explain.
`
`I'm sorry.
`
`We previously showed that there was
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`accessible via the top shelf of the -- the top surface of
`
`Page 689
`
`the cart.
`
`QO
`
`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 of all, it would be obvious to relocate the generator
`
`The prior art teaches that subject in that,
`
`
`
`sources.
`
`and the shielding to a lower elevation for ergonomic
`
`
`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.
`
`QO
`
`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
`
`A
`
`Yes, it does.
`
`Please explain.
`
`We have a radioactivity connector at the
`
`activity counter in the Klein thesis as well as in other
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`QO
`
`For the record, slide 130 shows an excerpt from
`
`Klein figure 2-2 on page 29.
`
`Is the radioactivity detector
`
`Page 690
`
`that's taught 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
`
`Let's move forward, please.
`
`We are on slide 131
`
`of the presentation.
`
`
`
`nothing inventive in that step.
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`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
`
`in the shielded well while a dose is pumped into it.
`
`He
`
`
`
`
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 691
`
`0
`
`Again for the record, slide 131 shows a split
`
`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
`
`Let's move forward, please. Claim 1 says that
`
`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.
`
`QO
`
`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?
`
`That's correct.
`
`A
`
`Q
`
`202-347-3700
`
`Ace-Federal Reporters,Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`the computer is configured to pump saline from a saline
`
`reservoir. Does the prior art teach this subject matter?
`
`Page 692
`
`A
`
`OQ
`
`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.
`
`0
`
`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
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`A
`
`Thank you.
`
`I'm sorry. Here we have the saline
`
`Page 693
`
`reservoir outside the cart.
`
`QO
`
`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.
`
`QO
`
`And does that process generate the rubidium
`
`radioactive eluate that is discharged through the outlet
`
`teach this subject matter?
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 694
`
`A
`
`Again,
`
`this is a block diagram from the Klein
`
`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?
`
`the activity when the sample is first placed in the well.
`
`A
`
`A
`
`Yes.
`
`What is that?
`
`The box with the little snowman is the shielded
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 695
`
`The computer then waits 30 minutes and takes another
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 696
`
`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
`
`slide 37.
`
`prior art?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Can you point it out
`
`to us?
`
`Here we have the strontium-rubidium generator in
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Claim 2 says that there is an eluate reservoir
`
`Page 697
`
`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
`
`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.
`
`QO
`
`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
`
`Les.
`
`Walk us through it, please.
`
`Well, we've talked about how it would be obvious
`
`to relocate the generator and the shielding compartment
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 698
`
`a lower elevation.
`
`Ergonomics is taught by Chaffin.
`
`If I
`
`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°32?
`
`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.
`
`
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 699
`
`opening, which refers back to the shielding compartment of
`
`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
`
`Here is the first opening. That's where it's
`
`located.
`
`nominally between 30 and 36 inches for ergonomics for a
`
`QO
`
`Okay.
`
`So let's go to the next element. And
`
`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.
`
`QO
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`workspace, using that as a reference of nominally 36
`
`inches,
`
`this first opening is halfway through. That would
`
`Page 700
`
`be between one and two feet.
`
`wherein clause, wherein the first shielding compartment
`
`Q
`
`And do you recall looking at the shielding
`
`generator this morning for the CardioGen 510?
`
`A
`
`QO
`
`E
`
`ido.
`
`Would you agree with me that the shielding
`
`
`compartment of that structure also was at the bottom of
`
`that cart?
`
`A
`
`Q
`
`Yes; it is.
`
`Let's move forward please to the next element.
`
`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.
`
`0
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`comprises two tubing passageways formed in a perimeter
`
`surface of the first opening.
`
`Let's talk about
`
`tubing passageways first.
`
`In
`
`the Klein thesis, how many tubing passageways go in and out
`
`Page 701
`
`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 of 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-E of 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 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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 702
`
`A
`
`Well,
`
`in the Tate system, using FDG, one merely
`
`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.
`
`QO
`
`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.
`
`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 of
`
`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.
`
`I do.
`
`QO
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Q
`
`A
`
`container.
`
`Q
`
`A
`
`QO
`
`And remind the Court, what is that?
`
`That is the source of rubidium-82 in a shielded
`
`Page 703
`
`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 -- over the
`
`vial of FDG.
`
`Q
`
`All right.
`
`For the record,
`
`I was pointing to
`
`684 as "this guy."
`
`So 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
`
`QO
`
`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.
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`the prior art?
`
`Page 704
`
`A
`
`Q
`
`A
`
`Q
`
`generator?
`
`A
`
`Q
`
`I do.
`
`Show me the front side.
`£
`Here is the front 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 access to the
`
`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 least 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.
`
`202-347-3700
`
`Ace-Federal Reporters,Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`taken from page 139 of the Klein thesis.
`
`We also have an
`
`excerpt showing figure 2-1 from the Klein thesis. Where in
`
`Page 705
`
`this daily protocol are the patient elution runs?
`
`A
`
`Patient elution runs are here after the
`
`completion of the calibration run.
`
`QO
`
`I was going to ask where in the daily protocol
`
`is the calibration run?
`
`A
`
`Q
`
`
`Tt'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
`
`assemble them, how to check their correct functioning.
`
`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
`
`202-347-3700
`
`Ace-Federal Reporters, Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Saline is indeed a consumable.
`
`The user is made
`
`Page 706
`
`aware of that through the user interface as described and
`
`taught by this standard.
`
`0
`
`Okay.
`
`For
`
`the record, on this slide 141 we
`
`haven excerpt
`
`from RX-114 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
`
`202-347-3700
`
`Ace-Federal Reporters,Inc.
`
`202-737-3638
`
`
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
`
`Page 707
`
`forward, please.
`
`Can we move forward.
`
`A
`
`0
`
`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.
`
`QO
`
`Let's move forw
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
