Norbert J. Pelc, Sc.D.
`
`CDX-0002C.
`
`01
`
`Bracco Ex. 2013
`Jubilant v. Bracco
`IPR2018-01449
`
`

`

`Norbert J. Pelc, Sc.D.
`
`• 1974: B.S., University of Wisconsin, Appl. Math, Engineering &
`Physics
`• 1979: Sc.D., Harvard University, Medical Radiological Physics
`• Served on the first National Advisory Council of the National
`Institute of Biomedical Imaging and Bioengineering of the NIH
`• Member, National Academy of Engineering
`• >40 years in medical imaging (11 in industry)
`• Professor of Bioengineering, Radiology, and, by courtesy, Electrical
`Engineering, Stanford University
`
`CDX-0002C.
`
`02
`
`

`

`Assignments
`
`•Provide an opinion regarding Bracco’s assertion of assignor
`estoppel
`•Respond to Respondents’ arguments that the asserted claims
`are invalid based on:
`• Anticipation
`• Obviousness
`• Prosecution laches
`• Improper inventorship
`
`CDX-0002C.
`
`03
`
`

`

`Person of Ordinary Skill in the Art
`
`• A POSITA at the time of the inventions claimed in the Asserted Patents
`would generally have:
`• a graduate degree in medicine and/or in a medical related science, including physics,
`chemistry, biology, physiology, and/or biophysics, or a related field
`• at least some clinical, research, and/or design experience with respect to PET imaging
`and/or PET imaging systems.
`• An individual with an undergraduate degree along with significant
`experience could also be sufficiently skilled.
`• Amount of experience following an undergraduate degree would depend on the level of
`formal education and amount of experience working with radiopharmaceuticals.
`• Such a person may be working as part of a team.
`
`CDX-0002C.
`
`04
`
`

`

`Legal Principles
`Legal Principles
`
`
`
`CDX-0002C.
`
`05
`
`

`

`Legal Principles
`
`•Validity
`• Presumption of Validity
`• Assignor Estoppel
`• Anticipation
`• Non-Obviousness
`• Prosecution Laches
`• Inventorship
`
`CDX-0002C.
`
`06
`
`

`

`Legal Principles
`
`•Presumption of Validity
`• Issued claims are presumed valid.
`• To overcome this presumption, Respondents must show by clear and
`convincing evidence that the challenged claims are invalid.
`
`CDX-0002C.
`
`07
`
`

`

`Legal Principles
`
`•Assignor Estoppel
`• One who assigns a patent to another party is an assignor.
`• The assignor and those in privity with the assignor are estopped from
`contesting the validity or enforceability of that patent when sued for
`infringement.
`
`CDX-0002C.
`
`08
`
`

`

`Legal Principles
`
`•Anticipation
`• A claim is anticipated when the Respondents show by clear and
`convincing evidence that each and every element set forth in the claim is
`found, either expressly or inherently, in a single prior art reference,
`before the priority date.
`
`CDX-0002C.
`
`09
`
`

`

`Legal Principles
`
`• Non-Obviousness
`• A claim is obvious when the Respondents show by clear and convincing evidence that
`the differences between the patented invention and the prior art are such that the
`subject matter as a whole would have been obvious at the time the invention was made
`to a POSITA.
`• The obviousness inquiry should not be performed with the benefit of hindsight, but
`instead must be based on the knowledge at the time of the invention.
`• It is not enough to demonstrate that each limitation was independently known in the art,
`there must have been a reason to combine the element in the manner claimed and
`there must have been a reasonable expectation of success in doing so.
`• Objective factors bearing on the question of non-obviousness may include, commercial
`success; long-felt but unmet need in the art; failures of others to meet a need met by
`the invention; unexpected results achieved by the invention; and praise of the invention
`by others.
`
`CDX-0002C.
`
`10
`
`

`

`Legal Principles
`
`• Prosecution Laches
`• A patent may be unenforceable when it has issued only after an unreasonable and
`unexplained delay in prosecution that constitutes an egregious misuse of the statutory
`patent system under the totality of the circumstances.
`• The mere passage of time from a patent application filing to the issuance of the patent
`is insufficient, in and of itself, to constitute improper delay as a matter of law.
`
`CDX-0002C.
`
`11
`
`

`

`Legal Principles
`
`•Inventorship
`• As part of the presumption of validity, the inventors as named in an
`issued patent are presumed to be correct.
`• To rebut this presumption, a party challenging patent validity for
`omission of an inventor must present clear and convincing evidence that
`an omitted individual actually invented the claimed invention.
`• A good faith error in designating inventorship cannot render a patent
`invalid, and can be corrected.
`
`CDX-0002C.
`
`12
`
`

`

`Asserted Patents
`
`CDX-0002C.
`
`13
`
`

`

`Asserted Patents
`
`-
`-
`-
`
`9,750,869 (“ʼ869 Patent”)
`9,750,870 (“ʼ870 Patent”)
`9,814,826 (“ʼ826 Patent”)
`
`JX-0001, -0002, 0003
`
`CDX-0002C.
`
`14
`
`

`

`Asserted Patents
`
`JX-0002
`
`15
`CDX-0002C.
`
`

`

`Asserted Claims
`
`Asserted Patents
`
`Asserted Claims
`
`9,750,869
`
`1-5, 8, 14, 24, and 29-30
`
`9,750,870
`
`1-2, 8, 10-12, 16-17, and 27
`
`9,814,826
`
`1-3, 5, 9, 11-14, and 17-19
`
`CDX-0002C.
`
`16
`
`

`

`Claim construction
`Claim Term
`“rubidium radioactive eluate”
`
`“strontium-rubidium radioisotope
`generator”
`
`“strontium breakthrough test result”
`
`Agreed Construction
`An eluate that contains radioactive rubidium
`
`A radioisotope generator that contains a
`radioisotope of strontium, which decays to a
`radioisotope of rubidium
`
`Test result representing the amount of a
`radioisotope of strontium in the test sample
`relative to the amount of a radioisotope of
`rubidium in the test sample
`
`Otherwise, “all limitations in the asserted claims should be given their plain
`and ordinary meaning.” (CX-0125)
`
`CDX-0002C.
`
`17
`
`

`

`Claims are not limited to figures
`
`JX-0002.008
`
`’869 Patent (JX-0002.043-44)
`
`’869 Patent (JX-0002.035); 8:12-23
`
`CDX-0002C.
`
`18
`
`

`

`Claims of the Asserted Patents go beyond mere automation
`
`’826 Patent (JX-0001.043)
`
`CDX-0002C.
`
`19
`
`

`

`Claims of the Asserted Patents go beyond mere automation
`
`’870 Patent (JX-0003.043-44)
`
`CDX-0002C.
`
`20
`
`

`

`Assignor Estoppel
`
`CDX-0002C.
`
`21
`
`

`

`Inventor Janet Gelbach assigned her rights in the Asserted
`Patents to Bracco
`
`* * *
`
`CX-0147, -0148, -0149, -0150
`
`CDX-0002C.
`
`22
`
`

`

`Inventor Janet Gelbach assigned her rights in the Asserted
`Patents to Bracco
`
`CX-0147, -0148, -0149, -0150
`
`CDX-0002C.
`
`23
`
`

`

`Janet Gelbach’s inventive work for Bracco
`
`2004:
`
`2008:
`
`Hired by Bracco as a
`clinical application
`specialist to work on the
`CardioGen-82 product.
`
`JX-0176C at 20:20-21:13,
`21:22-22:4, 26:10-14
`
`Suggests adding an on-
`board dose calibrator to the
`CardioGen-82 product
`based on her field work.
`
`JX-0176C at 95:7-96:14
`
`June 2008:
`
`Bracco files earliest
`priority application listing
`J. Gelbach as an inventor.
`
`July 2009:
`
`Bracco files PCT
`applications listing J.
`Gelbach as an
`inventor.
`
`JX-0001
`
`JX-0202
`
`2006-2010:
`
`Served as a “technical expert” on Bracco’s
`“redesign team” to develop the “next gen”
`CardioGen-82 product; provided monthly
`updates to her boss, William Abbott.
`
`JX-0176C at 26:15-27:27:6, 56:1-57:8, 95:7-96:14
`
`CDX-0002C.
`
`24
`
`

`

`(N
`———————————BRABBD
`v CDX—OOOZC. 25
`CDX-0002C. 25
`LIFE HID“ INSIDE
`
`

`

`Anticipation Rebuttal
`
`CDX-0002C.
`
`26
`
`

`

`Only alleged anticipating reference is not prior art
`
`•Respondents concede that
`the priority date of the
`asserted patents is at least
`as early as June 2009
`• Respondents’ only alleged
`anticipating reference – the
`2016 Ruby Manual – is not
`prior art
`
`CDX-0002C.
`
`27
`
`

`

`Obviousness Rebuttal
`
`CDX-0002C.
`
`28
`
`

`

`Respondents’ main alleged prior art references were considered during
`prosecution of the Asserted Patents
`
`JX-0001, -0002, -0003
`
`“Klein Thesis”
`
`CDX-0002C.
`
`29
`
`

`

`Respondents’ main alleged prior art references were considered during
`prosecution of the Asserted Patents
`
`JX-0001, -0002, -0003
`
`CDX-0002C.
`
`30
`
`

`

`Bracco overcame the examiner’s rejections based on Tate
`during prosecution of parent application
`
`11/7/12 Resp. to Office Action
`
`CX-0169.2223
`
`1/4/13 Office Action
`
`CX-0169.2243
`
`CDX-0002C.
`
`31
`
`

`

`Bracco overcame the examiner’s rejections based on Tate
`during prosecution of parent application
`
`* * *
`
`3/29/13 Resp. to Office Action
`
`CX-0169.2498
`
`10/2/13 Office Action
`
`CX-0169.2686
`
`CDX-0002C.
`
`32
`
`

`

`At least 15 elements of the Asserted Claims are missing from
`the Klein Thesis
`Respondents concede that at least 6 elements of the
`asserted claims are not disclosed in the Klein Thesis:
`1.
`“first door” / “second door”
`2.
`elevations of “first opening” and “second opening”
`3.
`“shielded well” on the cart
`4.
`“determine/determining a strontium breakthrough test
`result” in the “eluate reservoir in the shielded well on-
`board the cart while the eluate reservoir remains in the
`shielded well on-board the cart” / dose calibrator on-board
`the cart
`“two tubing passageways formed in a perimeter surface
`of the first opening” where “each of the two tubing
`passageways has a depth configured to prevent pinching
`or crushing of a corresponding tubing line routed
`therethrough when a/the first door is closed”
`computer is configured to (1) “track a volume of saline
`remaining in the saline reservoir” and (2) provide an alert
`“via the touch screen display when the volume of saline
`remaining in the saline reservoir is below a predetermined
`volume threshold”
`
`“exterior shell” and “interior space of the cabinet structure”
`“first shielding compartment” having “a first opening facing vertically
`upwardly”
`“opening through the top surface”
`configuring a computer / a computer configured “to not allow a
`patient infusion if the strontium breakthrough test result is greater
`than or equal to an allowed limit”
`“present on the touch screen display a screen reminding a user to
`insert the eluate reservoir in the shielded well on-board the cart”
`“present on the touch screen a screen indicating that the patient
`infusion is in process”
`“present on the touch screen display the strontium breakthrough
`test result”
`configuring a computer / a computer configured to “track time
`passed from completion of pumping the sample of the rubidium
`radioactive eluate into the eluate reservoir to measuring the
`strontium breakthrough test result”
`“a printer configured to print a document concerning a patient
`infusion or a quality control test result generated by the infusion
`system”
`
`5.
`
`6.
`
`At least 9 more elements are not disclosed in the Klein Thesis:
`
`1.
`2.
`
`3.
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`CDX-0002C.
`
`33
`
`

`

`Elements of the Asserted Claims missing from the Bracco
`Manual & CardioGen-82 Images
`
`• Respondents concede that there is no
`disclosure of:
`• computer or touch screen
`Respondents revert to relying on the Klein
`Thesis for these elements
`• shielded well or dose calibrator on-board the
`cart
`• first door / second door and “opening through
`the top surface”
`• “two tubing passageways formed in a
`perimeter surface of the first opening” where
`“each of the two tubing passageways has a
`depth configured to prevent pinching or
`crushing of a corresponding tubing line routed
`therethrough when a/the first door is closed”
`
`RX-0207.00013
`
`CDX-0002C.
`
`34
`
`

`

`82Rb and 13F systems differ significantly, thus a POSITA would
`not combine them
`
`Klein Thesis or
`Bracco Manual
`
`‘
`
`Tate '126 Application
`
`Redacted
`
`‘or
`
`Radiopharrnaoeutical
`
`32Rb Cl {RX-0106.0001?-18}
`
`13F FDG
`
`Radiopharmaceutical half-life
`
`1.27 minutes (T6 seconds} (Rx-
`0106.001?; REC-020100012}
`
`109.? minutes (1.9 hours}
`|——||
`
`Radiopharmaoeutical production
`
`Parent-daughter system for on cart elution Cyclotron and radiochemistrv hot cells (no
`ofSr-Rb generator {Rx-01 06.0001 7-13)
`generator)
`
`Time from production to administration
`
`Very rushed (RX-010600018)
`
`Not rushed
`
`Supply half-life
`
`30,792 minutes (25.5 days) (Rx-
`01 06.00016)
`
`109.? minutes
`
`Supply delivery
`
`1 to 2 months (RX-010600019)
`
`At least once a day
`
`Two radioisotopes present1 requiring
`breakthrough test
`
`Yes {RX-010600026; RX-0207.00045-46)
`
`No
`
`Potential for harm (absorbed dose over
`time}
`
`High (many orders of magnitude higher
`than 15F FDG)
`
`Lower
`
`Determination of radioactivity in material
`to go to patient
`
`On-board, in-line positron counter (RX-
`0106.00032; lax—20700024}
`
`On-board. ionization chamber
`I—l
`
`Timing of radioactivity determination
`
`On-the-fly, while flowing to patient (RX—
`0106.00042; RX-ZOT.00024}
`
`Flow is stationary
`
`Radioactive waste half-life
`
`1.27 minutes
`
`109.? minutes
`
`II§
`
`BEADED
`v cox-003$. 35-
`llll [It]! INSIDE
`CDX-0002C.
`
`

`

`Key differences relating to the “dose calibrator” in
`82Rb and 13F systems
`
`Used to measure radioactivity to be
`delivered to patient?
`
`No (RX-010630026, .00033; RX—207.00024)
`
`Yes
`
`Used to measure breakthrough?
`
`Yes (RX-0106.0002B)
`
`No
`
`Klein Thesis or
`Braoco Manual
`
`l—lor
`Tate ’126 Application
`
`
`Frequency of use
`
`Once a day (RX-0106.00028)
`
`Eve
`
`natient
`
`
`
`Background radiation on cart during
`measurement
`
`Very variable
`
`~Constant _||
`
`Location
`
`seems-010630034)
`
`On-cart
`
`Activity
`
`“Sr Activity————————————————
`
`Adapted from Klein Thesis (RX-0106.020. .028)
`
`
`
`
`Figure 1-4 — "as activity during
`recharging efa generator. An
`asymptotic rise is abscrved up to the
`level of all’Sr activity.
`
`
`i]
`10 mm
`..
`1‘ Measure A32 Rb
`Measure Aamkthmught
`
`Time
`
`I’§
`
`———————————————BFIADDD
`v cox—30320. 36
`l"! ”D" EISIIJE
`CDX-0002C.
`
`

`

`“exterior shell” and “interior space of the cabinet structure”
`
`ʼ869 independent claim 1
`
`ʼ870 independent claim 1
`
`ʼ826 dependent claim 14
`
`an exterior shell that extends
`upwardly above the platform and
`has a front side; a rear side; two
`sidewalls connecting the front side to
`the rear side; and a top surface;
`wherein the platform and the exterior
`shell collectively define an interior
`space of the cabinet structure
`
`wherein infusion system comprises a
`platform and an exterior shell
`extending upwardly above the
`platform, and wherein the platform
`and the exterior shell collectively
`define an interior space of a
`cabinet structure
`
`wherein the infusion system further
`comprises: an exterior shell
`extending upwardly above the
`platform, wherein the platform and
`the exterior shell collectively define
`an interior space of a cabinet
`structure
`
`CDX-0002C.
`
`37
`
`

`

`The Klein Thesis describes a cart with an open side
`
`• Respondents contend:
`
`•No “exterior shell”
`•No “interior space of the
`cabinet structure”
`
`Stone Rpt. ¶ 896
`
`CDX-0002C.
`
`38
`
`

`

`“first shielding compartment” having “a first opening facing
`vertically upwardly”
`
`ʼ869 independent claim 1
`a first shielding compartment in the
`interior space of the cabinet structure
`having a first opening facing
`vertically upwardly through which the
`strontium-rubidium radioisotope
`generator can be inserted into and
`removed from the first shielding
`compartment
`
`ʼ870 independent claim 1
`a strontium-rubidium radioisotope
`generator located in a first shielding
`compartment in the interior space of
`the cabinet structure . . . wherein the
`first shielding compartment has a first
`opening facing vertically upwardly
`
`ʼ826 independent claim 1
`installing a first shielding
`compartment, . . . wherein: the first
`shielding compartment has a first
`opening facing vertically upwardly,
`the first opening is configured for a
`strontium-rubidium radioisotope
`generator to be inserted into and
`removed from the first shielding
`compartment
`
`CDX-0002C.
`
`39
`
`

`

`“compartment” - plain and ordinary meaning
`
`• compartment
`• any of the divisions into which a space is partitioned off
`• a separate section, part, division, or category
`• Webster's New World College Dictionary, Fifth Edition Copyright © 2014 by Houghton Mifflin
`Harcourt Publishing Company.
`
`• compartment
`• 1 : a separate division or section
`• 2 : one of the parts into which an enclosed space is divided
`• https://www.merriam-webster.com/dictionary/compartment
`
`• compartment
`• a part or space marked or partitioned off.
`• a separate room, section, etc.:
`• a baggage compartment.
`• https://www.dictionary.com/browse/compartment
`
`CDX-0002C.
`
`40
`
`

`

`The Klein Thesis does not disclose a “first shielding compartment” having
`“a first opening facing vertically upwardly”
`
`RX-0106.033-34.
`
`CDX-0002C.
`
`41
`
`

`

`POSITA would not combine the Klein Thesis with Tate, which also does not disclose “first
`shielding compartment” having “a first opening facing vertically upwardly”
`
`• Respondents contend:
`
`• POSITA would not
`move the generator of
`the Klein Thesis as
`Respondents contend
`
`• Tate has no generator,
`no first shielding
`compartment having a
`first opening facing
`vertically upwardly
`
`CDX-0002C.
`
`42
`
`

`

`first / second “door” and “opening through the top surface”
`
`ʼ869 independent claim 1
`a first door accessible via the opening through the exterior shell, the first door being configured
`to provide access to the first shielding compartment and to close over the first opening;
`an opening through the top surface of the exterior shell configured to provide access for
`inserting a waste bottle into or removing the waste bottle from the interior space of the cabinet
`structure
`a second door accessible via the opening through the top surface of the exterior shell, the
`second door being configured to provide access to the second shielding compartment and to
`close over the second opening;
`
`CDX-0002C.
`
`43
`
`

`

`The Klein Thesis does not disclose a first/second door, and
`neither does Tate
`
`CDX-0002C.
`
`44
`
`

`

`Respondents’ combination of the Klein Thesis and Tate for first/second
`“door” and “opening through the top surface” fails
`
`• No disclosure of an
`“opening through the top
`surface” in the Klein
`Thesis
`• POSITA would not move
`the generator of the
`Klein Thesis as
`Respondents contend
`• Tate does not disclose a
`first/second door
`• POSITA would not
`combine the Klein
`Thesis and Tate
`
`CDX-0002C.
`
`45
`
`

`

`elevations of “first opening” and “second opening”
`
`ʼ869 independent claim 1
`wherein the first opening is located at a
`lower elevation than the second
`opening
`
`ʼ870 independent claim 1
`wherein the second shielding compartment
`on-board the cart has a second opening
`facing vertically upwardly and being at a
`higher elevation than the first opening
`
`ʼ826 independent claim 1
`the first opening is located at a lower
`elevation than the second opening
`
`ʼ869 dependent claim 3
`The infusion system of claim 2, wherein .
`. . , the first opening is at a first elevation,
`the second opening is at a second
`elevation, the first elevation is between
`approximately 1 foot and approximately 2
`feet, with respect to the lowermost portion
`of the cabinet structure, and the second
`elevation is between approximately 2 feet
`and approximately 3 feet, with respect to
`the lower surface of the platform.
`
`ʼ870 dependent claim 17
`The method of claim 16, wherein . . . , the
`first opening is at a first elevation, the
`second opening is at a second elevation,
`the first elevation is between
`approximately 1 foot and approximately 2
`feet, with respect to the lowermost portion
`of the cabinet structure, and the second
`elevation is between approximately 2 feet
`and approximately 3 feet, with respect to
`the lower surface of the platform.
`
`ʼ826 dependent claim 18
`The method of claim 17, wherein . . . , the
`first opening is at a first elevation, the
`second opening is at a second elevation,
`the first elevation is between
`approximately 1 foot and approximately 2
`feet, with respect to the lowermost portion
`of the cabinet structure, and the second
`elevation is between approximately 2 feet
`and approximately 3 feet, with respect to
`the lower surface of the platform.
`
`CDX-0002C.
`
`46
`
`

`

`The Klein Thesis does not disclose a first opening (for the generator) at a
`lower elevation than the second opening (for the waste bottle)
`
`• Respondents contend:
`
`• Klein Thesis does not disclose a first
`opening at a lower elevation than the
`second opening
`• POSITA would not modify the Klein
`Thesis as Respondents contend
`
`Stone Rpt. ¶ 629
`
`CDX-0002C.
`
`47
`
`

`

`Klein Thesis: layout is crucial
`
`RX-0106.049
`
`CDX-0002C.
`
`48
`
`

`

`A POSITA would not make Respondents’ proposed
`modifications to the disclosure of the Klein Thesis
`
`CDX-0002C.
`
`49
`
`

`

`A POSITA would not make Respondents’ proposed
`modifications to the disclosure of the Klein Thesis
`
`CDX-0002C.
`
`50
`
`

`

`A POSITA would not make Respondents’ proposed
`modifications to the disclosure of the Klein Thesis
`
`CDX-0002C.
`
`51
`
`

`

`A POSITA would not make Respondents’ proposed
`modifications to the disclosure of the Klein Thesis
`
`CDX-0002C.
`
`52
`
`

`

`“shielded well” on the cart
`
`ʼ869 independent claim 1
`a shielded well on-board the cart
`configured to receive an eluate
`reservoir, wherein the eluate reservoir
`is configured to receive a test sample
`
`ʼ870 independent claim 1
`inserting an eluate reservoir in a
`shielded well on-board the cart
`
`wherein the computer of the infusion
`system is configured to . . . fill the
`eluate reservoir in the shielded well
`on-board the cart with the test sample
`of the rubidium radioactive eluate
`
`placing the eluate reservoir in fluid
`communication with the eluate tubing
`line, wherein the computer is further
`configured to control the fluid
`communication between the eluate
`reservoir and the eluate tubing line;
`pumping a sample of the rubidium
`radioactive eluate into the eluate
`reservoir in the shielded well on-board
`the cart
`
`ʼ826 independent claim 1
`installing . . . a shielded well on a
`platform of a cart, wherein: the
`shielded well is configured to receive
`an eluate reservoir that is configured to
`receive a sample of the rubidium
`radioactive eluate
`configuring a computer with a touch
`screen display for the infusion system
`to: fill the eluate reservoir in the
`shielded well on-board the cart with
`the sample of rubidium radioactive
`eluate
`
`CDX-0002C.
`
`53
`
`

`

`“shielded well on-board the cart”
`
`Patent and Claim
`
`ʼ826 dependent claim 2
`
`ʼ869 dependent claim 28
`
`ʼ869 dependent claim 29
`
`Element
`measure a calibration radioactivity of the sample while
`the sample remains in the eluate reservoir
`in the
`shielded well on-board the cart
`compare the radioactivity of the sample measured while
`flowing through the eluate tubing line with the calibration
`radioactivity of
`the sample measured in the eluate
`reservoir in the shielded well on-board the cart
`the eluate reservoir located inside the shielded well on-
`board the cart and in fluid communication with the
`eluate tubing line
`the test sample filled into the
`measure an activity of
`eluate reservoir in the shielded well on-board the cart
`while the eluate reservoir remains in the shielded well
`on-board the cart, wherein the activity is measured with
`the dose calibrator in the shielded well on-board the cart
`
`CDX-0002C.
`
`54
`
`

`

`“determine/determining a strontium breakthrough test result” in the “eluate reservoir in the
`shielded well on-board the cart while the eluate reservoir remains in the shielded well on-
`board the cart” / dose calibrator on-board the cart
`
`ʼ869 independent claim 1
`wherein the computer of the infusion
`system is configured to . . . determine a
`strontium breakthrough
`test result on the test sample filled into
`the eluate reservoir in the shielded well
`on-board the cart while the eluate
`reservoir remains in the shielded well on-
`board the cart
`
`ʼ870 independent claim 1
`determining a strontium breakthrough
`test result on the sample pumped into
`the eluate reservoir in the shielded well
`on-board the cart while the eluate
`reservoir remains in the shielded well on-
`board the cart
`
`ʼ869 dependent claim 27
`The infusion system of claim 24, further
`comprising a dose calibrator located in
`the shielded well on-board the cart and in
`communication with the computer,
`wherein the dose calibrator is configured
`to determine the strontium
`breakthrough test result . . .
`
`ʼ870 dependent claim 16
`The method of claim 13, wherein the
`infusion system further comprises a dose
`calibrator in the shielded well on-board the
`cart and in communication with the
`computer to determine the strontium
`breakthrough test result.
`
`ʼ826 independent claim 1
`configuring a computer with a touch
`screen display for the infusion system to .
`. . determine a strontium breakthrough
`test result on the sample of the rubidium
`radioactive eluate filled into the eluate
`reservoir in the shielded well on-board the
`cart while the eluate reservoir remains in
`the shielded well on-board the cart
`
`ʼ826 dependent claim 3
`The method of claim 2, further comprising
`installing a dose calibrator in the shielded
`well on-board the cart, wherein the dose
`calibrator is in communication with the
`computer to measure the strontium
`breakthrough test result and the
`calibration radioactivity of the sample
`pumped into the eluate reservoir.
`
`CDX-0002C.
`
`55
`
`

`

`The Klein Thesis does not disclose a “shielded well” or dose
`calibrator on the cart
`• Respondents contend:
`
`• Respondents concede that the
`Klein Thesis does not disclose a
`shielded well or dose calibrator
`on the cart
`Klein Thesis does not disclose
`determining a strontium
`breakthrough test result in the
`“eluate reservoir in the shielded
`well on-board the cart while the
`eluate reservoir remains in the
`shielded well on-board the cart”
`• POSITA would not move the
`dose calibrator of the Klein
`Thesis on-board the cart
`
`Stone Rpt. ¶ 594
`
`CDX-0002C.
`
`56
`
`

`

`A POSITA would not rearrange the cart described in the Klein
`Thesis as proposed by Respondents
`•POSITA would not:
`• Move the dose calibrator on-
`board the cart
`• Move the generator to a lower
`elevation than the waste bottle
`
`CDX-0002C.
`
`57
`
`

`

`configuring a computer / a computer configured “to not allow a patient
`infusion if the strontium breakthrough test result is greater than or equal
`to an allowed limit”
`
`ʼ869 independent claim 1
`wherein the computer of the infusion
`system is configured to . . . not
`allow a patient infusion if the
`strontium breakthrough test result
`is greater than or equal to an
`allowed limit
`
`ʼ870 independent claim 1
`wherein the computer of the infusion
`system is further configured to not
`allow a patient infusion if the
`strontium breakthrough test result
`is greater than or equal to an
`allowed limit
`
`ʼ826 independent claim 1
`configuring a computer with a touch
`screen display for the infusion system
`to . . . not allow a patient infusion if
`the strontium breakthrough test
`result is greater than or equal to an
`allowed limit
`
`CDX-0002C.
`
`58
`
`

`

`The Klein Thesis does not disclose configuring a computer “to not allow a patient
`infusion if the strontium breakthrough test result is greater than or equal to an
`allowed limit”
`
`CDX-0002C.
`
`59
`
`

`

`“present on the touch screen display a screen reminding a user to insert
`the eluate reservoir in the shielded well on-board the cart”
`
`ʼ870 patent dependent claim 8
`The method of claim 2, wherein the computer of the infusion
`system is further configured to: . . . present on the touch
`screen display a screen reminding a user to insert the
`eluate reservoir in the shielded well on-board the cart . . .
`
`ʼ826 patent dependent claim 9
`The method of claim 2, further comprising configuring the
`computer to: . . . present on the touch screen display a
`screen reminding a user to insert the eluate reservoir
`in the shielded well on-board the cart . . .
`
`• References cited by Respondents do not disclose configuring a
`computer / a computer configured to “present on the touch screen
`display a screen reminding a user to insert the eluate reservoir in the
`shielded well on-board the cart”
`
`CDX-0002C.
`
`60
`
`

`

`“present on the touch screen a screen indicating that the patient infusion
`is in process”
`
`ʼ870 patent dependent claim 8
`The method of claim 2, wherein the computer of the infusion
`system is further configured to: . . . present on the touch
`screen display a screen indicating that the patient
`infusion is in process, wherein the screen indicating that
`the patient infusion is in process displays a stop button to
`abort the patient infusion . . .
`
`ʼ826 patent dependent claim 9
`The method of claim 2, further comprising configuring the
`computer to: . . . present on the touch screen display a
`screen indicating that the patient infusion is in process,
`wherein the screen indicating that the patient infusion is in
`process displays a stop button to abort the patient infusion .
`. .
`
`CDX-0002C.
`
`61
`
`

`

`“two tubing passageways formed in a perimeter surface of the first opening” where “each of
`the two tubing passageways has a depth configured to prevent pinching or crushing of a
`corresponding tubing line routed therethrough when a/the first door is closed”
`
`’869 dependent claims 4 and 24
`The infusion system of claim 1, wherein the
`first shielding compartment comprises two
`tubing passageways formed in a
`perimeter surface of the first opening, and
`each of the two tubing passageways has
`a depth configured to prevent pinching or
`crushing of a corresponding tubing line
`routed therethrough when the first door is
`closed thereover.
`
`’870 dependent claim 12
`The method of claim 11, wherein . . . two
`tubing passageways formed in a
`perimeter surface of the first opening,
`wherein each of the two tubing
`passageways has a depth configured to
`prevent pinching or crushing of a
`corresponding tubing line routed
`therethrough when a first door is closed
`over the first opening.
`
`’826 dependent claim 13
`The method of claim 12, wherein . . . two
`tubing passageways formed in a
`perimeter surface of the first opening,
`wherein each of the two tubing
`passageways has a depth configured to
`prevent pinching or crushing of a
`corresponding tubing line routed
`therethrough when a first door is closed
`over the first opening.
`
`The infusion system of claim 1, . . . wherein:
`the first shielding compartment comprises
`two tubing passageways formed in a
`perimeter surface of the first opening,
`each of the two tubing passageways has
`a depth configured to prevent pinching or
`crushing of a corresponding tubing line
`routed therethrough when the first door is
`closed thereover, the first door is mounted
`via a hinge . . .
`
`CDX-0002C.
`
`62
`
`

`

`Tate does not disclose “two tubing passageways formed in a perimeter surface of the first opening”
`where “each of the two tubing passageways has a depth configured to prevent pinching or crushing of a
`corresponding tubing line routed therethrough when a/the first door is closed”
`
`CDX-0002C. 63
`
`

`

`The CardioGen-82 Images do not disclose “two tubing passageways formed in a perimeter
`surface of the first opening” where “each of the two tubing passageways has a depth
`configured to prevent pinching or crushing of a corresponding tubing line routed
`therethrough when a/the first door is closed”
`
`Adapted from CardioGen-82 Images, RX-0357.07
`
`CDX-0002C.
`
`64
`
`

`

`computer is configured to (1) “track a volume of saline remaining in the saline reservoir”
`and (2) provide an alert “via the touch screen display when the volume of saline remaining
`in the saline reservoir is below a predetermined volume threshold”
`
`’869 dependent claim 14
`The infusion system of claim 1,
`wherein the computer of the infusion
`system is further configured to track
`a volume of the saline remaining in
`the saline reservoir and to alert the
`user via the touch screen display
`when the volume of the saline
`remaining in the saline reservoir is
`below a predetermined volume
`threshold.
`
`’870 dependent claim 10
`The method of claim 9, wherein the
`computer of the infusion system is
`further configured to: track a volume
`of saline remaining in the saline
`reservoir, provide an alert via the
`touch screen display when the
`volume of saline remaining in the
`saline reservoir is below a
`predetermined volume threshold . . .
`
`’826 dependent claim 11
`The method of claim 10, further
`comprising configuring the computer
`to: . . . track a volume of saline
`remaining in the saline reservoir,
`provide an alert via the touch screen
`display when the volume of saline
`remaining in the saline reservoir is
`below a predetermined volume
`threshold . . .
`
`CDX-0002C.
`
`65
`
`

`

`“present on the touch screen display the strontium
`breakthrough test result”
`
`’870 dependent claim 8
`The method of claim 2, further comprising configuring the
`computer to: . . . present on the touch screen display the
`strontium breakthrough test result.
`
`’826 dependent claim 9
`The method of claim 2, wherein the computer of the infusion
`system is further configured to: . . . present on the touch
`screen display the strontium breakthrough test result.
`
`• No disclosure of
`presenting the
`strontium
`breakthrough
`test result on the
`touch screen
`display
`
`CDX-0002C.
`
`66
`
`

`

`configuring a computer / a computer configured to “track time passed from
`completion of pumping the sample of the rubidium radioactive eluate in