PUBLIC VERSION
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS,
`AND COMPONENTS THEREOF
`INCLUDING GENERATORS
`
`Inv. No. 337-TA-1110
`
`COMMISSION OPINION
`
`On August 1, 2019, the presiding Administrative Law Judge ("All") in the above-
`
`identified investigation issued a final initial determination ("FID") finding no violation of section
`
`337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 ("section 337"). Having
`
`considered the FID, the parties' petitions, responses thereto, and the record in this investigation,
`
`the Commission has determined to affirm with modification the FID's findings and ultimate
`
`conclusion of no violation of section 337. Specifically, the Commission has determined to
`
`affirm the FID's conclusion with respect to the invalidity of the asserted claims and supplements
`
`the FID's findings on that issue. In addition, the Commission has determined to affirm in part
`
`and vacate in part the FID's findings with respect to the domestic industry requirement. All
`
`findings in the FID that are consistent with this opinion are affirmed.
`
`I.
`
`BACKGROUND
`
`A.
`
`Procedural Background
`
`The Commission instituted this investigation on May 1, 2018, based on a complaint, as
`
`amended, filed by Bracco Diagnostics Inc. ("Bracco") of Monroe Township, New Jersey. See
`
`83 Fed. Reg. 19112 (May 1, 2018). The complaint, as amended, alleges violations of section
`
`337 based upon the importation into the United States, the sale for importation, and the sale
`
`1
`
`JUBILANT EXHIBIT 1040
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`PUBLIC VERSION
`
`within the United States after importation of certain strontium-rubidium radioisotope infusion
`
`systems, and components thereof including generators, by reason of infringement of claims 1-3,
`
`5, 9-14, 17-19, 26, and 28 of U.S. Patent No. 9,814,826 ("the '826 patent") (JX-1); claims 1-5, 8,
`
`14, 24, and 27-30 of U.S. Patent No. 9,750,869 ("the '869 patent") (JX-2); and claims 1, 2, 8-13,
`
`16, 17, 22, and 27 of U.S. Patent No. 9,750,870 ("the '870 patent") (JX-3) (collectively,
`
`"Asserted Patents"). See id. The notice of investigation names Jubilant DraxImage Inc. of
`
`Kirkland, Quebec, Canada; Jubilant Pharma Limited of Singapore; and Jubilant Life Sciences of
`
`Noida, Uttar Pradesh, India (collectively, "Jubilant") as respondents in this investigation. See
`
`id. The Office of Unfair Import Investigations is also a party to this investigation. See id.
`
`On August 8, 2018, the Commission partially terminated the investigation as to claims 10
`
`and 26 of the '826 patent, claims 27 and 28 of the '869 patent, and claims 9 and 22 of the '870
`
`patent based on the withdrawal of the allegations pertaining to those claims. See Order No. 15
`
`(Aug. 8, 2019), unreviewed, Comm'n Notice (Sept. 6, 2019). On September 4, 2018, the All
`
`partially terminated the investigation as to claim 13 of the '870 patent based on the withdrawal of
`
`the allegations pertaining to that claim. See Order No. 18 (Sept. 4, 2019), unreviewed, Comm'n
`
`Notice (Sept. 26, 2019).1
`
`On February 8, 2019, the AU J issued an ID (Order No. 27) granting Bracco's motion for
`
`summary determination that Jubilant's RUBY Rubidium Elution System Version 3.0 ("the
`
`Version 3 product") infringes the Asserted Patents. See Order No. 27 (Feb. 8, 2019),
`
`unreviewed, Comm'n Notice (Mar. 8, 2019). In addition, the ID grants Jubilant's motion for
`
`summary determination that Jubilant's RUBY Rubidium Elution System Version 3.1 ("the
`
`1 Hereinafter, "Asserted Claims" means claims 1-3, 5, 9, 11-14, 17-19, and 28 of the '826 patent,
`claims 1-5, 8, 14, 24, and 29-30 of the '869 patent, and claims 1, 2, 8, 10-12, 16, 17, and 27 of
`the '870 patent.
`
`2
`
`

`

`PUBLIC VERSION
`
`Version 3.1 product") and the RUBY Rubidium Elution System Version 4 ("the Version 4
`
`product") do not directly infringe the Asserted Patents. See id The ID (Order No. 27) declines
`
`to reach indirect infringement on summary determination. See id at 20.
`
`The AU J conducted an evidentiary hearing on February 11-12 and 15-17, 2019, and on
`
`August 1, 2019, issued the FID finding no violation of section 337. Specifically, the FID finds
`
`that the domestic industry requirement is satisfied and that all the Asserted Claims are infringed
`
`but invalid as obvious over the prior art. In addition, the FID also contains the AL's
`
`recommended determination ("RD"), recommending, should the Commission find a violation of
`
`section 337, that the Commission issue a limited exclusion order ("LEO") barring entry of
`
`articles that infringe the Asserted Claims. However, the RD recommends delaying the effective
`
`date of the LEO by 12 months to allow sufficient time for facilities with infringing systems to
`
`switch to other models. The RD does not recommend that the Commission issue a cease and
`
`desist order ("CDO") or impose a bond during the period of Presidential review. Furthermore,
`
`as directed by the Commission, the RD provides findings with respect to the public interest and
`
`recommends a determination that the public interest factors do not preclude entry of the
`
`recommended remedy.
`
`On August 14, 2019, both Bracco and the Commission's Investigative Attorney ("IA")
`
`filed petitions for review of the FID.2 Bracco petitioned for review of the FID's findings with
`
`2 See Complainant Bracco Diagnostics Inc.'s Petition for Review of Initial Determination
`(hereinafter, "Bracco's Pet"); Office of Unfair Import Investigations' Petition for Review of the
`Final Initial Determination (hereinafter, "IA's Pet.").
`
`3
`
`

`

`PUBLIC VERSION
`
`respect to invalidity while the IA petitioned for review of the FID's findings with respect to
`
`domestic industry. On August 22, 2019, the parties filed responses to the petitions.3
`
`On September 30, 2019, the Commission issued a notice determining to review the FID
`
`in part. See 84 Fed. Reg. 53177 (Oct. 4, 2019). Specifically, the Commission determined to
`
`review the FID's findings with respect to invalidity and domestic industry.
`
`B.
`
`The Asserted Patents
`
`The Asserted Patents are related and share the same specification. The Asserted Patents
`
`issued between September 5 and November 14, 2017.4 See FID at 4. The Asserted Patents,
`
`titled "Integrated Strontium-Rubidium Radioisotope Infusion Systems," relate to computer-
`
`assisted medical devices that generate and infuse radiopharmaceuticals (e.g., rubidium-82 or Rb-
`
`82) into a patient. See JX-1, '826 patent at Abstract, 1:27-30. The infused dose of
`
`radiopharmaceutical is absorbed by the cells of a target organ of the patient and emits radiation,
`
`which is detected by positron emission tomography ("PET"), thereby generating an image of the
`
`organ. See id. at 1:35-42.
`
`For example, the common specification explains that:
`
`[C]ircuit 300 includes: an eluant reservoir 15, for example, a bag,
`bottle or other container, containing saline as the eluant, . . . ; a
`syringe pump 33, for pumping the eluant from reservoir 15, and a
`pressure syringe 34 (or other device or sensor), for monitoring
`pumping pressure; a filter 37, which may also serve as a bubble trap,
`
`3 See Complainant Bracco Diagnostics Inc.'s Response to Office of Unfair Import
`Investigations' Petition for Review of Initial Determination (hereinafter, "Bracco's Resp.");
`Respondents' Response to Complainant's Petition for Review (hereinafter, "Jubilant's Resp.");
`Office of Unfair Import Investigations' Response to Complainant's Petition for Review of the
`Final Initial Determination (hereinafter, "IA's Resp.").
`
`4 On their face, the earliest priority date of the Asserted Patents appears to be June 11, 2008.
`However, the parties agree that the relevant priority date for all three patents is June 11, 2009.
`Jubilant argued for a later priority date in the context of an invalidity (anticipation) challenge but
`the FID rejected that challenge and determined that the priority date of the Asserted Patents was
`indeed June 11, 2009. See FID at 122-25. Jubilant did not petition for review of the finding.
`
`4
`
`

`

`PUBLIC VERSION
`
`for the pumped eluant; a radioisotope generator 21, through which
`the filtered eluant is pumped to create a radioactive eluate, for
`example an eluate carrying Rubidium-82 that is generated by the
`decay of Strontium-82, via elution, within a column of generator 21;
`and an activity detector 25, for measuring the activity of the eluate
`discharged from generator 21, in order to provide feedback for
`directing the flow of the eluate, via a divergence valve 35WP, either
`to a waste bottle 23 or through a patient line 305p, for example, to
`inject a dose of the radiopharmaceutical eluate into a patient."
`
`See id. at 5:3-20, Figure 1D (reproduced below).5
`
`3Q0B
`
`Fig. 1D
`
`,-- 300
`
`.21
`
`15
`
`302 - 37
` 35BG
`
`• ;) frfi Do/
`
`1 ( 302
`-311
`317
`
`304 --""
`
`301
`
`, 34
`
`yr
`
`• 33
`
`303
`
`--305P
`1-315
`-OP
`
`; r
`
`-305P
`
`00
`
`35WP
`
`25
`
`is% f"--305W
`.43‘214
`
`-305
`
`Pik
`
`23
`
`200
`
`The specification also states that "circuit 300 [can be] expanded to include elements for
`
`an automated collection of eluate samples for activity measurements, via the on board dose
`
`calibrator." See id. at 8:13-16. The specification explains that "a sample collection reservoir
`
`5 As noted in the FID, "[a]s the generator ages, strontium starts to detach from the column and
`contaminate the eluate, posing a risk to patient health" (known as "strontium breakthrough").
`To prevent any patient exposure from strontium breakthrough, operators must perform frequent
`quality-control checks on the generator. See FID at 7.
`
`5
`
`

`

`PUBLIC VERSION
`
`[can be] integrated into circuit 300, downstream of divergence valve 35WP and in
`
`communication with tubing line 305P, in order to receive quality control test samples of eluate,
`
`via tubing line 305P, and both the reservoir and the dose calibrator are located in a separate
`
`shielded well." See id. at 8:17-23.
`
`The specification further explains that "[a]ctivity detector 25 is mounted in a shielded
`
`well 255 that extends downward from opening 325 (shown in FIG. 3B, reproduced below), and,
`
`with reference to FIG. 3B, tubing line 305 passes over opening 325 so that detector 25 can detect
`
`an activity of the eluate, which passes therethrough." See id. at 12:21-25.
`
`..tf
`
`Fig. 3B
`
`301
`
`302
`
`305p
`
`,23
`
`35wp
`
`251b
`
`251g
`303 —
`304
`35BG-
`
`302- 231 -
`
`201
`
`—205
`2150
`
`255
`
`305
`
`--233
`
`-305w
`
`-- 203
`
`05p
`
`— 305w
`
`-- 325
`
`305
`
`25
`
`The Asserted Claims recite a method or a system relating to a strontium-rubidium
`
`infusion system "on-board" a cart. See, e.g., '826 patent at claim 1 (reproduced below). In
`
`particular, the system is configured to "determine a strontium breakthrough test result on [a]
`
`sample of the rubidium radioactive eluate filled into the eluate reservoir in the shielded well on-
`
`6
`
`

`

`PUBLIC VERSION
`
`board the cart while the eluate reservoir remains in the shielded well onboard the cart" and "not
`
`allow a patient infusion if the strontium breakthrough test result is greater than or equal to an
`
`allowed limit." See id.
`
`Claims 1, 9, and 13 of the '826 patent are representative and recite (with disputed
`
`limitations in bold):
`
`1. A method of building an infusion system to deliver a rubidium
`radioactive eluate comprising:
`installing a first shielding compartment,6 a second shielding
`compartment, and a shielded wed on a platform of a cart, 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,
`the second shielding compartment has a second opening facing
`vertically upwardly,
`the second opening is configured for a waste bottle to be inserted
`into and removed from the second shielding compartment,
`the first opening is located at a lower elevation than the second
`opening,8 and
`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 the rubidium radioactive eluate by pumping
`saline from a saline reservoir into the strontium-rubidium
`radioisotope generator via a saline tubing line thereby generating the
`rubidium radioactive eluate that is discharged through an eluate
`tubing line,
`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 onboard the cart, and not allow a
`
`6 The "first shielding compartment" element is referred to, hereinafter, as "claim limitation (i)."
`7 The "shielded well" element is referred to, hereinafter, as "claim limitation (ii)."
`8 The element reciting "the first opening [] located at a lower elevation than the second opening"
`element is referred to, hereinafter, as "claim limitation (iii)."
`
`7
`
`

`

`PUBLIC VERSION
`
`patient infusion if the strontium breakthrough test result is greater
`than or equal to an allowed limit.9
`
`9. The method of claim 2, further comprising configuring the
`computer to:
`present on the touch screen display a screen for starting the
`patient infusion by touching a button on the touch screen display;
`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 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; and
`present on the touch screen display the strontium
`breakthrough test result.1°
`
`13. The method of claim 12, wherein the infusion system is
`configured for the saline tubing line and the eluate tubing line to be
`routed through 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."
`
`An additional disputed limitation appears in claim 1 of the '869 patent which recites "[a]n
`
`infusion system on-board a cart comprising. . . an opening through the exterior shell
`
`configured to provide access to the strontium-rubidium radioisotope generator," "a first door
`
`accessible via the opening through the exterior shell, the first door being configured to provide
`
`9 The element reciting "configuring a computer . . . to fill the eluate reservoir. . . with the
`sample of the rubidium radioactive eluate, . . . determine a strontium breakthrough test result, . . .
`and not allow a patient infusion if the strontium breakthrough test result is greater than or equal
`to an allowed limit" is referred to, hereinafter, as "claim limitation (iv)."
`I° The elements reciting "present on the touch screen display a screen reminding a user to insert
`the eluate reservoir in the shielded well on-board the cart. . . and present on the touch screen
`display the strontium breakthrough test result it" are referred to, hereinafter, as "claim limitation
`(vii)."
`11 The element reciting "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" is referred to, hereinafter, as "claim limitation (v)."
`
`8
`
`

`

`PUBLIC VERSION
`
`access to the first shielding compartment and to close over the first opening," and "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."12 See JX-2, '869 patent at 24:24-25:33. The '870 patent also recites several
`
`disputed claim limitations which are cumulative of the limitations discussed above.
`
`C.
`
`Bracco's Domestic Industry Products
`
`As noted in the FID, the domestic industry product is Bracco's CardioGen 1700 rubidium
`
`infusion system ("Model 1700").13 See FID at 8. There is no dispute that the CardioGen1700
`
`practices at least one claim of each of the Asserted Patents and thus satisfies the domestic
`
`industry requirement as to the "article[sr protected by the patents. See id. at 128-29. The FID
`
`further determines that Bracco's investments with respect to the articles protected by the asserted
`
`patents are sufficient to satisfy the domestic industry requirement under subsections
`
`337(a)(3)(A)-(C). See id. at 129-49. As noted above, the Commission determined to review
`
`the FID's findings with respect to domestic industry.
`
`D.
`
`Jubilant's Accused Products
`
`The accused products in this investigation are Jubilant's RUBY Rubidium Elution
`
`Systems (Versions 3, 3.1, and 4) as well as the generators (RUBY-FILL generators) and tubing
`
`sets (RUBY Sets) used with those systems.14 See FID at 7. As noted above, the Commission
`
`previously determined that the Version 3 product directly infringes the Asserted Patents but that
`
`12 The elements reciting "an opening through the exterior shell," "a first door," and "a second
`door" are referred to, hereinafter, as "claim limitation (vi)."
`13 Bracco's CardioGen 1700 is not on the market and is currently awaiting FDA approval.
`14 Jubilant's Version 3.1 and Version 4 products are not on the market and are currently awaiting
`FDA approval.
`
`9
`
`

`

`PUBLIC VERSION
`
`the Version 3.1 and 4 products do not directly infringe the Asserted Patents. See Order No. 27
`
`(Feb. 8, 2019), unreviewed, Comm'n Notice (March 8, 2019). The FID finds that Jubilant
`
`indirectly infringes the Asserted Patents when it ships a RUBY-FILL generator or RUBY Set to
`
`a customer that possesses a Version 3 system. See FID at 127-28. No party petitioned for
`
`review of the FID's findings with respect to indirect infringement, and the Commission
`
`determined not to review these findings. See 84 Fed. Reg. at 53177.
`
`STANDARD ON REVIEW
`
`Commission Rule 210.45(c) provides that "[o]n review, the Commission may affirm,
`
`reverse, modify, set aside or remand for further proceedings, in whole or in part, the initial
`
`determination of the administrative law judge" and that "Nile Commission also may make any
`
`findings or conclusions that in its judgment are proper based on the record in the proceeding."
`
`See 19 C.F.R. § 210.45(c). In addition, as explained in Certain Polyethylene Terephthalate
`
`Yarn and Products Containing Same, "[o]nce the Commission determines to review an initial
`
`determination, the Commission reviews the determination under a de novo standard." Inv. No.
`
`337-TA-457, Comm'n Op., 2002 WL 1349938, *5 (June 18, 2002) (citations omitted). This is
`
`"consistent with the Administrative Procedure Act which provides that once an initial agency
`
`decision is taken up for review, 'the agency has all the powers which it would have in making
`
`the initial decision except as it may limit the issues on notice or by rule." Id. (citing 5 U.S.C.
`
`§ 557(b)).
`
`III. DISCUSSION
`
`As discussed below, the Commission has determined to affirm with modification and to
`
`supplement the FID's findings with respect to the invalidity of the Asserted Claims. In addition,
`
`10
`
`

`

`PUBLIC VERSION
`
`the Commission has determined to affirm in part and vacate in part the FID's findings with
`
`respect to the domestic industry requirement.
`
`A.
`
`Invalidity
`
`The FID finds that all of the Asserted Claims are obvious over Klein15 (RX-106) alone or
`
`in combination with Tate16 (RX-103), the MedRad Intego system, which is the commercial
`
`embodiment of the Tate device17 (RX-200C), Chaffin18 (RX-96), IEC 6236619 (RX-114), or
`
`Bracco's CardioGen-82 Model 51020 (JX-112C; RX-357). See FID at 25-112. The FID also
`
`considers the evidence of secondary considerations but finds such evidence unpersuasive and
`
`insufficient to overcome the finding ofprima facie obviousness. See id. at 112-121.
`
`As explained below, the Commission has determined to affirm the FID with
`
`modification. The Commission supplements the FID's findings and conclusion of obviousness.
`
`The Commission finds that Jubilant has satisfied its burden on obviousness and has established
`
`by clear and convincing evidence that the Asserted Claims are obvious over Klein alone or in
`
`15 Klein refers to a thesis published in 2006 describing a rubidium infusion system developed by
`Ran Klein as part of his graduate studies at the University of Ottawa. See FID at 25.
`
`16 Tate refers to U.S. Publication 2008/0177126 filed by MedRad on October 31, 2007.
`
`17 The MedRad Intego system is the commercial embodiment of the device disclosed in Tate.
`See FID at 35. The MedRad Intego system was sold and offered for sale in the United States
`prior to June 2009. See id
`
`18 Chaffin refers to an ergonomics and biomechanics reference. See Chaffin, et al.,
`Occupational Biomechanics, 2d ed. (1991). Chaffin teaches sensible ways to physically arrange
`heavy objects used by humans. See FID at 37.
`
`19 IEC 62366 is an international standard for medical device design. See FID at 38. As stated
`in the FID, "IEC 62366 teaches medical device developers to provide a user interface that
`enables users 'to be aware of the use of the correct consumable, the remaining amount of [the
`consumable], whether accessories might be used with the MEDICAL DEVICE, how to assemble
`them and how to check their correct functioning.' See FID at 62-63.
`20 Bracco's CardioGen-82 Model 510 ("Model 510") is a strontium-rubidium cardiac PET
`infusion system first approved by the FDA in 1989. See FID at 26.
`
`11
`
`

`

`PUBLIC VERSION
`
`combination with Tate/Medrad, Chaffin, IEC 62366, or Model 510.21 The Commission has also
`
`determined that Bracco has established copying but no other indicia of non-obviousness, and that
`
`such copying is insufficient to overcome Jubilant's strong showing of obviousness.
`
`1.
`
`Disputed Claim Limitations
`
`The FID identifies several claim limitations that are in dispute, including four limitations
`
`that appear in claim 1 of each of the Asserted Patents: (1) "a shielded well onboard the cart"
`
`("claim limitation (i)"); (2) "a first shielding compartment for the generator" having "a first
`
`opening facing vertically upwardly" ("claim limitation (ii)"); (3) "the first opening [(of the
`
`generator compartment)] at a lower elevation than the second opening [(of the waste bottle
`
`compartment)]" ("claim limitation (iii)"); and (4) "a computer [configured] to fill an on-cart
`
`reservoir with a sample of radioactive material, determine a strontium breakthrough test result on
`
`the sample, and not allow a patient infusion if the strontium breakthrough test result is greater
`
`than or equal to an allowed limit." ("claim limitation (iv)"). See FID at 40-54. Bracco
`
`petitioned for review of the FID's findings with respect to each of the four above-identified
`
`limitations. See Bracco' g Pet. at 25-52, 56-59.
`
`In addition, Bracco petitioned for review of the FID's findings with respect to three
`
`additional limitations: (1) '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,"
`
`which is recited in claim 13 of the '826 patent, claims 4 and 24 of the '869 patent, and claim 12
`
`21 Klein, Tate, and the user manual for Bracco's Model 510 were before the U.S. Patent and
`Trademark Office ("USPTO") during prosecution of the Asserted Patents. Based on the
`evidence presented in this investigation, the Commission finds that Jubilant satisfies the "added
`burden" of overcoming those references. See McGinley v. Franklin Sports, Inc., 262 F.3d 1339,
`1353 (Fed. Cir. 2001) (citation omitted).
`
`12
`
`

`

`PUBLIC VERSION
`
`of the '870 patent ("claim limitation (v)"); (2) "opening through the top surface' and the first /
`
`second 'door," which are recited in claim 1 of the '869 patent ("claim limitation (vi)"); and
`
`(3) "reminders, warnings, or alerts," which are recited in claim 9 of the '826 patent and claim 8
`
`of the '870 patent ("claim limitation (vii)"). See id. 52-56, 60-67.
`
`2.
`
`Supplemental Analysis
`
`(i)
`
`Claim Limitation (i)
`
`There is no dispute that Klein does not expressly disclose a "shielded well on-board the
`
`cart" (claim limitation (i)). See FID at 40. But while Klein's dose calibrator sits on a
`
`laboratory shelf, i.e., off the cart, the parties did not dispute that the dose calibrator satisfies the
`
`"shielded well" limitation. See id.; Jubilant's Resp. at 5 (citing Klein at RX-106.34 (showing
`
`the Klein system and dose calibrator on the laboratory shelf) (reproduced below as annotated)).
`
`RX.0106.0034 (annotated)
`
`13
`
`

`

`PUBLIC VERSION
`
`The Commission agrees with the FID that the record evidence shows that Klein alone
`
`teaches or suggests a "shielded well on-board the cart" by clear and convincing evidence. See
`
`FID at 40-45. It is black letter law that "when a patent 'simply arranges old elements with each
`
`performing the same function it had been known to perform' and yields no more than one would
`
`expect from such an arrangement, the combination is obvious." KSR Intl Co. v. Teleflex Inc.,
`
`550 U.S. 398, 416 (2007). As in KSR, there is no evidence in the record that "the [claimed]
`
`improvement is more than the predictable use of prior art elements according to their established
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`functions." See id. at 417; id. ("If a person of ordinary skill can implement a predictable
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`variation, § 103 likely bars its patentability."); see also FID at 44 (finding that "mov[ing] the
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`Klein dose calibrator onto the cart" was "nothing more than routine design work well within the
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`ability of a person of skill in the art") (citing Hr'g Tr. at 847:10-848:14 (Stone22), id. ("[T]he
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`only two passages in the patent specification describing the dose calibrator on-board the cart
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`simply announce that fact without describing any difficulty in making or using that
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`arrangement.") (citing JX-1, '826 patent at 11:8-19, 27:9-12); see also Jubilant's Resp. at 33-34
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`("A dose calibrator is a well-known component of a rubidium infusion system, and a movable
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`cart provides a convenient location to place a dose calibrator in a rubidium infusion system, but
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`it adds nothing to the nature or quality of the dose calibrator.") (citing Anderson's-Black Rock v.
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`Pavement Co., 396 U.S. 57 (1969); KSR, 550 U.S. at 416); IA's Resp. at 16-20 ("Dr. Stone's
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`testimony . . . makes clear that Klein contemplates improvements to disclosed system.") (citing
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`Hr'g Tr. at 823:13-18 (Stone)).
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`The FID also correctly finds that several design incentives would have motivated a
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`person of ordinary skill in the art to move the dose calibrator on board the cart, including
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`22 Dr. Robert Stone is Jubilant's technical expert in this investigation.
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`mobility, operational simplicity, and minimizing radiation exposure to the operator. See FID at
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`41-42 (citing Klein at RX-106.24-25, 27, 29, 38, 44, 46, 141; Hr'g Tr. at 623:9-22 (Stone)
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`(describing the difficulty of repeatedly rolling the cart back to a stationary dose calibrator)),
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`619:17-620:1, 622:23-624:1 (Stone) (testifying that it would have been obvious to a person of
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`ordinary skill in the art using the Klein system for commercial clinical applications to put
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`components used together on the same cart)).
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`The Commission also finds that clear and convincing evidence in the record establishes
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`that the combination of Klein with Tate or Medrad teaches or discloses a "shielded well on-board
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`the cart." The parties did not dispute that Tate/Medrad disclose infusion systems that place dose
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`calibrators (shown below in blue) on-board the cart. See Jubilant's Resp. at 40 (citing Tate at
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`RX-103.5, Figure 1D; Medrad at RX-200C.18 (both reproduced below as annotated)).
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`FIG. 1D
`Tate at RX-103.5, Figure 1D (annotated)
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`Medrad at RX-200C.18 (annotated)
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`Bracco argued that Tate and Medrad are not analogous prior art and that the USPTO
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`found Tate to be "too far afield." See Bracco's Pet. at 70. Bracco is wrong; the USPTO
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`Examiner made no such finding. Indeed, neither the patentee nor the Examiner stated during
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`prosecution of the parent patent application that Tate was non-analogous art. Rather, the
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`PUBLIC VERSION
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`Examiner considered Tate relevant and pertinent prior art and cited it against the pending claims
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`of the parent patent application. See CX-169, Prosecution History at 2139; see also id. at 2150
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`("Tate et al. and Varrichio et al. are analogous art because they are from a similar problem
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`solving area of using pumps to infuse liquid into a patient."). Moreover, the patentee
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`distinguished Tate on the basis that it does not generate radiopharmaceuticals, not because it was
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`non-analogous art. See id. at 2223-2224 ("Tate is directed to a fluid delivery system for
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`delivering doses of pharmaceuticals to a patient. . . . Unlike the fluid delivery system of Tate,
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`independent claim 1 recites a system that includes a radioisotope generator."). Subsequently,
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`the Examiner withdrew the rejection over Tate but nowhere suggested that she considered Tate
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`non-analogous or "too far afield," as Bracco contends. See id at 2243, 2286. Rather, the
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`prosecution history suggests no more than the typical negotiation between the patentee and the
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`USPTO Examiner over the scope of relevant prior art.
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`Importantly, there is no requirement for analogous prior art to be similar in all respects.
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`As the FID correctly notes, "Nile field of endeavor of a patent is not limited to the specific point
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`of novelty, the narrowest possible conception of the field, or the particular focus within a given
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`field." See FID at 34 (citing Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir.
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`2016)). Rather, as the FID determines, Tate and Medrad are analogous because "Tate is in the
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`same field of endeavor as the present invention, as both are 'systems that. . . infuse
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`radiopharmaceuticals,. . . including computer-facilitated maintenance and/or operation." See
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`Ed The FID also correctly finds that "Tate was directed to at least some of the same problems
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`as the asserted patents, namely calculating and delivering accurate and effective doses of
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`radiopharmaceuticals to patients, while reducing the exposure of administering or other medical
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`personnel' caused by manual handling of samples for calibration." See id at 35 (citing Tate,
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`RX-103.89-90; JX-1, '826 Patent at 1:25-30; Hr'g Tr. at 616:22-617:23, 867:11-17 (Stone); id at
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`1113:25-1114:4 (Pe1c23)); FID at 33 ("Tate is directed to a system for use with
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`fluorodeoxyglucose (`FDG'), a different radiopharmaceutical than the rubidium-82 described in
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`the asserted patents" but "because 'radioisotopes, such as. . . Rubidium-82 . . .' and FDG are
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`useful in medical imaging due to their 'relatively short half-lives,' systems that use these
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`isotopes face the same problem of tracking the level of radioactivity delivered to the patient with
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`each dose.") (citing R)(-103.89, Tate); id. at 35-36 (finding Medrad "pertinent. . . for the same
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`reasons addressed above concerning Tate"); accord Jubilant's Resp. at 26-27 (citing JX-1, '826
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`patent at 1:25-30; Tate at RX-103.89-90, 100; Hr'g Tr. at 616:22-617:23, 867:11-17 (Stone);
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`Hr'g Tr. at 1113:25-1114:4 (Pelc)); see also id. at 27 ("Dr. Pelc ultimately admitted that FDG
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`systems and rubidium systems 'have similarities and they have differences.") (citing Hr'g Tr. at
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`1071:5-7 (Pelc)).24
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`Bracco also argued that there is no motivation to combine Tate or Medrad with Klein.
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`See Bracco's Pet. at 74-75. Bracco focuses on the fact that Tate does not generate
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`radiopharmaceuticals, but that is not dispositive because, as discussed above at page 16, there is
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`no requirement that Tate disclose every claimed limitation. What is significant is that Tate is
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`analogous prior art (both Tate and Klein relate to systems that infuse radiopharmaceuticals), and
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`Tate discloses the missing claim limitation, i.e., Tate places the dose calibrator on-board the cart
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`in FDG systems. Given the design incentives discussed above and in the FID, and given that
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`Tate expressly discloses placing a dose calibrator on-board the cart, a person of ordinary skill in
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`23 Dr. Norbert J. Pelc is Bracco's technical expert in this investigation.
`24 The FID also notes that "Dr. Pelc testified to the contrary" but that "his testimony [is] less
`credible on this point