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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`JUBILANT DRAXIMAGE INC.,
`Petitioner,
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`
`______________
`
`
`Case IPR2018-01449
`Patent 9,299,467
`
`______________
`
`Patent Owner Sur-Reply
`
`
`
`
`
`IPR2018-01449
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`U.S. Patent No. 9,299,467
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`
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`Patent Owner Sur-Reply
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`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`INTRODUCTION .......................................................................................... 1
`
`KLEIN DOES NOT DISCLOSE A COMPUTER THAT PREVENTS
`PATIENT INFUSIONS IF A STRONTIUM BREAKTHROUGH TEST
`RESULT EXCEEDS AN ALLOWABLE LIMIT ......................................... 1
`
`PETITIONER HAS NOT CARRIED ITS BURDEN TO SHOW THAT
`THE BRACCO MANUAL QUALIFIES AS A PRINTED PUBLICATION
` ........................................................................................................................ 8
`
`IV. PETITIONER CANNOT NOW CHANGE ITS BASIS FOR DR.
`MURTHY’S TESTIMONY .........................................................................10
`
`V.
`
`THE ITC’S INITIAL DETERMINATION REGARDING RELATED
`PATENTS IS NOT BINDING AND MAY BE REVIEWED ....................11
`
`VI. CONCLUSION ............................................................................................13
`
`
`
`
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Brand v. Miller,
`487 F.3d 862 (Fed. Cir. 2007) ............................................................................ 12
`
`Celltrion, Inc. v. Biogen, Inc.,
`IPR2017-01093, Paper 12 (PTAB Oct. 6, 2017) .................................................. 9
`
`Garrett Corp. v. United States,
`422 F.2d 874 (Ct. Cl. 1970) .................................................................................. 9
`
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 8
`
`In-Depth Geophysical, Inc. v. ConocoPhillips Co.,
`IPR2019-00849, Paper 14 (PTAB Sept. 6, 2019) ................................................. 9
`
`Instradent Usa, Inc. v. Nobel Biocare Servs. Ag,
`No. IPR2015-01786, 2017 WL 10242133 (P.T.A.B. Feb. 15, 2017) .......... 11, 12
`
`Intel Corp. v. Qualcomm, Inc.,
`No. IPR2018-01344, 2019 WL 325929 (P.T.A.B. Jan. 23, 2019),
`aff’d 903 F.3d 1365 (Fed. Cir. 2018) .................................................................. 11
`
`Kinetic Tech, Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00690 (PTAB Oct. 19, 2015) ................................................................ 8
`
`Kyocera Wireless Corp. v. ITC,
`545 F.3d 1340 (Fed. Cir. 2008) ............................................................................ 9
`
`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) ............................................................................ 8
`
`Los Angeles County Metro. Trans. Auth. v. Transp. Techs., LLC,
`IPR2016-01633, Paper 22 (PTAB Nov. 17, 2017) ............................................. 10
`
`Sandoz Inc. v. Abbvie Biotechnology Ltd.,
`IPR2017-01824, Paper 14 (PTAB Feb. 9, 2018) .................................................. 9
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`Page ii of iv
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`U.S. Patent No. 9,299,467
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`Statutes
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`Patent Owner Sur-Reply
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`35 U.S.C. §316(e) ...................................................................................................... 8
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`Page iii of iv
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`EXHIBIT LIST
`
`2007
`
`2008
`
`2009
`
`Description
`Exhibit
`2001 U.S. Patent No. 6,767,319 to Reilly et al.
`2002 Comparison of U.S. Patent No. 6,767,319 to U.S. Patent Application
`Publication No. 2004/0260143 to Reilly et al.
`2003 Declaration of Dr. Norbert Pelc
`ITC Deposition of Dr. Robert Stone, October 9, 2018 (Redacted)
`2004
`ITC Deposition of Dr. Robert Stone, October 10, 2018 (Redacted)
`2005
`ITC Trial Testimony of Dr. Robert Stone, April 15, 2019 (Public
`2006
`Version)
`ITC Trial Testimony of Dr. Robert Stone, April 16, 2019 (Public
`Version)
`Errata of Dr. Robert Stone regarding Ex. 1015 of IPRs 2018-01448,
`-01449, and -01450
`Exhibit from Deposition of Dr. Robert Stone in IPRs 2018-01448,
`-01449, and -01450
`2010 Deposition testimony of Dr. Robert Stone in IPRs 2018-01448, -01449,
`and -01450
`ITC Corrected Expert Report of Dr. Norbert Pelc (Redacted)
`2011
`ITC Trial Testimony of Dr. Norbert Pelc (Public Version)
`2012
`ITC Trial Exhibits of Dr. Norbert Pelc (Redacted)
`2013
`2014 CAPINTEC CRC-15R User Manual, Nov. 2004
`2015 CAPINTEC CRC-15R User Manual, July 2007
`2016 Deposition testimony of Dr. Venkatesh Murthy in IPRs 2018-01448,
`-01449, and -01450
`Exhibit 1001 from Dr. Murthy’s Deposition (corrections to Ex. 1017)
`
`2017
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`
`
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`I.
`
`INTRODUCTION
`
`Patent Owner Bracco Diagnostics Inc. (“Bracco”) submits the following
`
`response to Petitioner’s Reply (“Reply”). Petitioner argues that Klein discloses a
`
`computer that prevents patient infusions based on strontium breakthrough testing.
`
`But the Reply confirms that Petitioner’s case is predicated on reading into Klein
`
`something that does not exist – an express disclosure of the computer preventing
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`patient infusions based on strontium breakthrough test results. These arguments
`
`consist largely of attorney argument and lack meaningful rebuttal to the opinions of
`
`Bracco’s expert, Dr. Pelc. For example, Petitioner continues to rely on piecemeal
`
`quotations from Klein that Petitioner’s expert, Dr. Stone, relies on “in aggregate” for
`
`this claim limitation. (Reply at 6.) Dr. Pelc, however, detailed why a POSITA
`
`would have understood that Klein, when read as a whole instead of as a piecemeal
`
`collection of quotations, does not disclose this claim limitation. Petitioner also did
`
`not depose Dr. Pelc in this matter, leaving his testimony unchallenged.
`
`Accordingly, Petitioner has failed to show that the Challenged Claims are
`
`unpatentable.
`
`II. KLEIN DOES NOT DISCLOSE A COMPUTER THAT PREVENTS
`PATIENT INFUSIONS IF A STRONTIUM BREAKTHROUGH TEST
`RESULT EXCEEDS AN ALLOWABLE LIMIT
`
`The Petitions filed in this proceeding and IPR2018-01448 & -01450 fail
`
`because Klein does not disclose a computer that prevents a patient infusion
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`procedure if a strontium breakthrough test result exceeds an allowable limit. (POR
`
`at §IV.) As explained in the POR, the relevant claims are 2, 21, and 24 (’468 patent)
`
`and 1 and 13 (’467 patent). Bracco refers to the applicable limitations of these claims
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`as the “prevent limitations.” (Id.)
`
`Petitioner cannot show that Klein discloses the prevent limitations. Instead,
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`Petitioner’s contention that Klein discloses the prevent limitations relies on
`
`selectively excerpting the record and mere attorney argument. First, however,
`
`Bracco provides a brief explanation of how the breakthrough test result is determined
`
`in Klein.
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`Specifically, as Dr. Pelc explained, Klein’s breakthrough testing is completed
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`by:
`
`“[T]aking advantage of the very different half-life between rubidium
`
`and the parent strontium. . . . to do the breakthrough test, you elute
`
`the generator and you measure the activity of rubidium that’s there.
`
`And Klein calls that A82 rubidium. You now know how much
`
`rubidium is in the eluate. You then wait a long time. Klein teaches
`
`waiting 30 minutes. And then you measure what Klein calls A~
`
`breakthrough. That should not have any more rubidium from the
`
`original eluate. That should have all decayed in the 30 minutes. So
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`any radioactivity in that very late measurement should reflect
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`breakthrough.” (Ex. 2012-ITC Tr. at 971:4-19.)
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`This testimony is unchallenged. Bracco’s expert further explained that Klein is
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`“describing that the calibration run and measurement of the activity levels is
`
`required. The system then has to go calculate the breakthrough test result[.]” (Id. at
`
`1078:21-23.)
`
`The dispute centers on whether Klein discloses a computer that prevents a
`
`patient infusion if the strontium breakthrough test result—a calculated ratio based
`
`on breakthrough measurements—exceeds an allowable limit. As detailed in
`
`Bracco’s response (POR at 13-20), and explained again below, Klein does not
`
`disclose this claim element. Petitioner conflates the issues by pointing to disclosures
`
`in Klein relating to whether/when the system is locked out due to expiration of
`
`system calibration, not due to breakthrough results exceeding an allowable limit, as
`
`required by the claims.1 (Reply at 3-11.) For example, Petitioner contends that Dr.
`
`
`1 Petitioner’s reference to the user interface with selectively enabled and disabled
`
`functions is a red herring. (See Reply at 3-5.) Petitioner does not and cannot connect
`
`this aspect of Klein’s user interface with the prevent limitations. Klein’s disclosure
`
`of “a computer-controlled infusion system” (Reply at 3) addressed the problem of
`
`reducing “measurable activity rate fluctuations” to achieve increased precision in the
`
`eluted activity. (Ex. 1014-Klein at iii (Abstract); see also id.at 2, 25-27, 71-97, 116-
`
`121, 124-126, and 130-132.)
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`Pelc agreed that Klein “locks the system out until a strontium breakthrough test is
`
`performed.” (Id. at 5.) This contention is incorrect, as it selectively excerpts Dr.
`
`Pelc’s testimony. Dr. Pelc’s full testimony details the basis for his conclusion that:
`
`“There’s nothing in the Klein thesis that says that based on the
`
`calculation of the breakthrough test, the computer prevents patient
`
`elutions. It does not say that.” (Ex. 2012-ITC Tr. at 983:7-9.)
`
`Contrary to Petitioner’s position, Dr. Pelc explained:
`
`“a successful calibration run in Klein means you went through these
`
`[calibration] steps. You flushed the generator. You flushed the lines.
`
`You -- there was no failure of the pump. There is no failure of the
`
`dose calibrator. The dose calibrator gave you numbers. And that’s
`
`what a successful run means. And if you do this, you can go on to do
`
`patient elutions.” (Ex. 2012-ITC Tr. at 982:25-983:6.)
`
`Dr. Pelc’s testimony is consistent with the excerpts from Klein on which Petitioner
`
`relies, including that Klein’s software “ensured that the protocol (discussed below)
`
`is followed.” (Reply at 6 (citing Ex. 1014-Klein at 17).) But, as detailed in the POR,
`
`Klein does not disclose that the software also prevents patient infusions based on the
`
`breakthrough test result (a calculation) exceeding an allowable limit. (POR at 12-
`
`19.)
`
`Petitioner misreads Klein when it cites Klein’s statement that “[o]nly after a
`
`calibration run with low Sr breakthrough has been successfully completed can
`
`patient elutions be carried out.” (Reply at 11 (citing Ex. 1014-Klein at 18).) As Dr.
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`Pelc explained, however, “none [of] the above cited portions of Klein expressly
`
`disclose a computer that prevents patient infusion procedures based on strontium
`
`breakthrough testing results.” (Ex. 2003-Pelc at ¶95 (emphasis original).) Petitioner
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`also selectively quotes Klein to contend that “it is the computer’s ‘software’ – not
`
`its operator – that causes Patient Elution runs to be ‘enabled only after the
`
`prerequisites [e.g., the low Sr breakthrough] have been completed successfully.’”
`
`(Reply at 11 (quoting Ex. 1014-Klein at 44).) However, this statement in Klein does
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`not mention breakthrough. Instead, it appears 25 pages later than the first quoted
`
`statement regarding calibration runs and low breakthrough. Indeed, Klein states that
`
`its “infusion system software must ensure that the protocol is followed (i.e. that each
`
`run is enabled only avert the prerequisites have been completed successfully).” (Ex.
`
`1014-Klein at 44.) As described above, there is no question that Klein requires that
`
`the calibration protocol is followed. But Klein does not disclose that the computer
`
`prevents patient infusions if a strontium breakthrough test result exceeds an
`
`allowable limit.
`
`Petitioner did not depose Dr. Pelc in this proceeding,2 and relies only on
`
`attorney argument to rebut his testimony, stating: “Klein assigns responsibility for
`
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`2 Petitioner’s failure to depose Dr. Pelc here further undermines Petitioner’s
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`unfounded allegation that his opinion is not credible. (See Reply at 10.)
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`re-enabling patient infusions to the computer’s software.” (Reply at 6.) While citing
`
`precedent that “the relevant question” is what a POSITA “would reasonably
`
`understand or infer from the prior art,” Petitioner’s Reply depends on statements
`
`from its attorneys to conclude that a “POSITA would recognize immediately from
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`Klein’s disclosure that the computer ‘prevent[s] a patient infusion procedure if a
`
`breakthrough test result exceeds an allowable limit.’” (Id. at 7.) Petitioner also
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`implicitly admits that Klein does not disclose the prevent limitations, because it
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`further relies on Dr. Stone’s conclusion that “[t]his discussion, in aggregate,
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`discloses to a POSITA that Klein’s computer ‘prevent[s] a patient infusion
`
`procedure if a breakthrough test result exceeds an allowable limit.’” (Reply at 7
`
`(citing Ex. 1015-Stone at ¶252) (emphasis added).)
`
`Indeed, the statements relied upon “in aggregate” by Petitioner and Dr. Stone
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`are similar to statements in the CardioGen 510 User Manual, which instructs that:
`
`“PATIENT ADMINISTRATION MAY BE PERFORMED ONLY
`
`AFTER
`
`SUCCESSFUL
`
`COMPLETION
`
`OF
`
`DAILY
`
`CALIBRATION, SR-82/85 BREAKTHROUGH PROCEDURES,
`
`AND FIRST WASH (ELUTION) DISPOSAL USING SAME
`
`SETTINGS AS SEEN ON SR-82/85 BREAKTHROUGH SHEET
`
`PAGE” (Ex. 1021 at 31 (emphasis added).)
`
`It is uncontested that the CardioGen 510 User Manual does not disclose a computer
`
`to perform strontium breakthrough testing, or to decide whether to perform patient
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`infusions. The operator must take the activity measurements and perform the
`
`requisite calculations to determine the strontium breakthrough test result, and then
`
`decide whether to perform patient infusions. (See Ex. 1021 at 34-35 (“Sr-82/85
`
`Breakthrough Worksheet”).) Similarly, there is no “overwhelming disclosure from
`
`Klein” that the computer prevents patient infusions if a strontium breakthrough test
`
`result exceeds an allowable limit, as Petitioner contends. (Reply at 5.) To the
`
`contrary, Klein teaches that the decision to perform patient infusions based on a
`
`strontium breakthrough test result is left to the operator. (Ex. 2003-Pelc at ¶¶95-96.)
`
`Petitioner again relies on selectively excerpting the evidence with respect to
`
`skipping breakthrough test measurements. Petitioner contends that “Klein discloses
`
`that manual readings are the exception, not the norm, and automated breakthrough
`
`testing suffices in many cases.” (Reply at 9.) However, Klein states that “[i]f the
`
`eluted 82Rb activity is insufficient to accurately measure breakthrough, the automatic
`
`measurement is skipped.” (Ex. 1014-Klein at 52 (emphasis added).) This is not an
`
`“exception,” but a reflection of Klein’s software programming. A POSITA would
`
`not have understood this to be a disclosure in Klein that the computer prevents a
`
`patient elution when the automatic breakthrough measurement is skipped, or a
`
`requirement that the operator must manually enter breakthrough activity when this
`
`occurred. (See Ex. 2012-ITC Tr. at 983:10-984:23.)
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`Petitioner’s discussion of Klein’s breakthrough experiments also misses the
`
`mark. Petitioner explains that “Klein confirms that ‘if significant Sr activity is
`
`detected, the generator cannot be used on humans.’” (Reply at 9 (emphasis
`
`original) (quoting Ex. 1014-Klein at 122).) Klein does not mention the computer
`
`preventing a patient infusion due to such significant Sr activity. Rather, it supports
`
`Dr. Pelc’s analysis showing that the operator, not the computer, makes the decision.
`
`(Ex. 2003-Pelc at ¶97.)
`
`III. PETITIONER HAS NOT CARRIED ITS BURDEN TO SHOW THAT
`THE BRACCO MANUAL QUALIFIES AS A PRINTED
`PUBLICATION
`
`Petitioner argues that it carried its burden to show that the Bracco Manual
`
`qualifies as prior art. (Reply at §III.) This is plainly false. A petitioner bears the
`
`burden of establishing a reference is prior art. 35 U.S.C. §316(e); Harmonic Inc. v.
`
`Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); see also Kinetic Tech, Inc.
`
`v. Skyworks Solutions, Inc., IPR2014-00690 (PTAB Oct. 19, 2015); Judges Lora
`
`Green & Brian McNamara, “Best Practices For Proving A Document Is A Printed
`
`Publication,”
`
`(Dec.
`
`7,
`
`2017),
`
`available
`
`at
`
`https://www.uspto.gov/sites/default/files/documents/boardside_chat_on_prior_art_
`
`12_7_17.pdf, at 19 (explaining that public accessibility is a substantive issue that is
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`not properly addressed via objections or motions to exclude). The key inquiry is
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`whether a reference was made “sufficiently accessible to the public interested in the
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`art.” In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009) (quoting In re Cronyn, 890
`
`F.2d 1158, 1160 (Fed. Cir. 1989)). A reference is “publicly accessible” if it has been
`
`“disseminated or otherwise made available to the extent that persons interested and
`
`ordinarily skilled in the subject matter or art exercising reasonable diligence[] can
`
`locate it.” Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350 (Fed. Cir. 2008)
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`(internal marks omitted); see also Sandoz Inc. v. Abbvie Biotechnology Ltd.,
`
`IPR2017-01824, Paper 14 at 5-8 (PTAB Feb. 9, 2018); Celltrion, Inc. v. Biogen,
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`Inc., IPR2017-01093, Paper 12 at 9-10 (PTAB Oct. 6, 2017); In-Depth Geophysical,
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`Inc. v. ConocoPhillips Co., IPR2019-00849, Paper 14 at 9-13 (PTAB Sept. 6, 2019).
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`Petitioner’s evidence of public accessibility is nonexistent. The Board made
`
`clear that this issue would be analyzed after full development of the record.
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`(Decision at 17.) The record has now been fully developed, and despite the Board’s
`
`guidance, Petitioner did not seek any discovery on this issue from Bracco, did not
`
`depose Bracco’s expert, and did not seek to file supplemental information. Thus,
`
`the evidence consists of the Bracco Manual, which lists a 2004 date and says nothing
`
`about public accessibility, and Bracco’s explanation that the document was only
`
`disseminated to its customers under an obligation of confidentiality. (POR at 19.)
`
`In light of this evidence, Petitioner argues that mere distribution of a document to a
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`commercial entity is sufficient for public accessibility. (Reply at 13-16 (citing
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`Garrett Corp. v. United States, 422 F.2d 874, 878 (Ct. Cl. 1970)).) Petitioner
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`mischaracterizes the law. The Board has previously explained that the evidence in
`
`Garrett showed an intent to make the document in question “freely accessible” to
`
`members of the interested public, and that Garrett’s reasoning does not apply where
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`the record fails to show that the interested public would be advised of the availability
`
`of a document or the cost at which a copy could be obtained. See, e.g., Los Angeles
`
`County Metro. Trans. Auth. v. Transp. Techs., LLC, IPR2016-01633, Paper 22 at 16-
`
`21 (PTAB Nov. 17, 2017). Given that Petitioner bears the burden of establishing
`
`the Bracco Manual as prior art by a preponderance of the evidence, and given it has
`
`not submitted or sought to obtain any evidence to discharge this burden, the Bracco
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`Manual is not prior art. Thus, Ground 3 must fail.
`
`IV. PETITIONER CANNOT NOW CHANGE ITS BASIS FOR DR.
`MURTHY’S TESTIMONY
`
`The final section of Petitioner’s Reply responds to Bracco’s argument with
`
`respect to the weight that should be accorded to Dr. Murthy’s testimony. (Reply at
`
`15-17.) In these arguments, Petitioner argues that Bracco’s criticism of Dr. Murthy’s
`
`testimony relates to specific issues that are not material to disputes in the case. (Id.)
`
`This is incorrect. Dr. Murthy repeatedly testified regarding “standard medical
`
`practice” as of 2008, and, in general, the evidence for this testimony was either (a)
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`Dr. Murthy’s experience (whether cited or not) or (b) an “Infusion Manual” that was
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`not in the record until Petitioner improperly served it at Dr. Murthy’s deposition.
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`(POR at 20-21.) Dr. Murthy’s testimony is highly suspect given that he admitted at
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`his deposition that his experience with respect to rubidium-82 did not even begin
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`until July 2008, and he did not know whether or when the “Infusion Manual” would
`
`have been available to interested individuals (Ex. 2016-Murthy at 41:10-22, 32:19-
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`38:4.) Moreover, Dr. Murthy’s credibility in this regard is relevant to Petitioner’s
`
`evidence as a whole. As the Reply shows, Dr. Stone is not an expert on topics
`
`involving medical uses of rubidium-82, so he looks to Dr. Murthy to explain these
`
`topics. (Reply at 16.) While that might be appropriate in some circumstances, it is
`
`not credible here because Dr. Murthy repeatedly testified about “standard medical
`
`practice[s]” by 2008, based on experience he did not have and on a document that
`
`he is not sure was ever publicly available.
`
`V. THE ITC’S INITIAL DETERMINATION REGARDING RELATED
`PATENTS IS NOT BINDING AND MAY BE REVIEWED
`
`As Petitioner notes, an initial determination (“ID”) issued by an administrative
`
`law judge at the International Trade Commission found obvious the asserted claims
`
`of three patents in the same family as the instituted patent here. But, the Board
`
`independently assesses the evidence in this IPR without deference. (See Reply at
`
`n.3.) IDs (and ITC decisions generally) are not binding on the Board. Intel Corp. v.
`
`Qualcomm, Inc., No. IPR2018-01344, 2019 WL 325929, at *10 (P.T.A.B. Jan. 23,
`
`2019), aff’d 903 F.3d 1365 (Fed. Cir. 2018); Instradent Usa, Inc. v. Nobel Biocare
`
`Servs. Ag, No. IPR2015-01786, 2017 WL 10242133, at *1 (P.T.A.B. Feb. 15, 2017).
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`Moreover, Bracco has submitted a petition for review of the ID by the ITC
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`Commissioners.3
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`Indeed, Petitioner relies on aspects of the ID that undermine the ALJ’s
`
`conclusions and warrant review by the ITC Commissioners. For example, Petitioner
`
`cites the ID regarding whether Klein “locks out” (or prevents) patient elutions based
`
`on the strontium breakthrough test result. (Reply at 11-12.) The ALJ’s analysis
`
`should be accorded little weight here, because (a) it is irrelevant to these proceedings
`
`and (b) the ALJ improperly substituted his own opinion for that of a POSITA in the
`
`ID. (E.g., Ex. 1035 at 51 (citing only Klein, and not testimony from either expert).)
`
`See Brand v. Miller, 487 F.3d 862, 870-71 (Fed. Cir. 2007) (“Brand argues that the
`
`Board improperly substituted its own opinion for evidence of the knowledge of one
`
`of ordinary skill in the art. We agree ... There was also no testimony from one skilled
`
`in the art that the drawings communicated an enabling invention to a skilled recipient
`
`of the drawings.”)
`
`
`3 In compliance with the July 2018 Trial Practice Guide (at II.I), which prohibits
`
`submission of evidence with a patent owner sur-reply, Bracco has not submitted a
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`copy of its petition for review, or the related responses filed by Petitioner and the
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`ITC’s Office of Unfair Import Investigations, with this sur-reply. Bracco can submit
`
`these materials if the Board would prefer.
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`Page 12 of 14
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`
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`IPR2018-01449
`
`U.S. Patent No. 9,299,467
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`
`
`Patent Owner Sur-Reply
`
`Finally, Petitioner goes too far in contending that the ALJ found Dr. Stone
`
`more credible than Dr. Pelc “on the lockout feature.” (Reply at 12.) Rather, in
`
`declining to adopt Dr. Pelc’s opinions regarding the “lockout” claim element, the
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`ALJ did not find that Dr. Pelc’s opinions were not credible. (See Ex. 1035 at 49-
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`54.) Further, as described above, the ALJ improperly substituted his own analysis
`
`of Klein regarding the “lockout” claim element rather than accepting Dr. Stone’s
`
`testimony. (See Reply at 11-12; Ex 1035 at 52-53.)
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`VI. CONCLUSION
`
`In view of the foregoing, Bracco respectfully requests that the Board find that
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`Petitioner has failed to carry its burden to show that the Challenged Claims are
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`unpatentable.
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`
`
`Dated: September 16, 2019
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`
`
`Respectfully submitted,
`
`GREENBERG TRAURIG, LLP
`
`
`
`
`
`/s/ Heath J. Briggs
`Heath J. Briggs (Reg. No. 54,919)
`GREENBERG TRAURIG, LLP
`1144 15th Street, Suite 3300
`Denver, CO 80202
`Phone: (303) 572-6500
`briggsh@gtlaw.com
`
`Barry J. Schindler (Reg. No. 32,938)
`GREENBERG TRAURIG, LLP
`500 Campus Drive, Suite 400
`Florham Park, NJ 07932
`
`Page 13 of 14
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`
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`IPR2018-01449
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`U.S. Patent No. 9,299,467
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`
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`Patent Owner Sur-Reply
`
`Telephone: 973-360-7900
`SchindlerB@gtlaw.com
`
`Counsel for Patent Owner Bracco
`Diagnostics Inc.
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`Page 14 of 14
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`
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`IPR2018-01449
`
`U.S. Patent No. 9,299,467
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`
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`Patent Owner Sur-Reply
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on this 16th day of September, 2019, a copy of this
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`Patent Owner Sur-Reply including all attachments and exhibits has been served in
`
`its entirety via electronic mail by emailing Petitioner’s lead and backup counsel at:
`
`Robert L. Hails
`rhails@bakerlaw.com
`T. Cy Walker
`cwalker@bakerlaw.com
`Theresa M. Weisenberger
`tweisenberger@bakerlaw.com
`Jubilant-Baker@bakerlaw.com
`
`as provided for by Petitioner’s listed Service Information in its Petition.
`
`
`
`
`
`
`
` Respectfully submitted,
`
` GREENBERG TRAURIG, LLP
`
`Date: September 16, 2019
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Heath J. Briggs
`Heath J. Briggs
`Registration No. 54,919
`1144 15th Street, Suite 3300
`Denver, CO 80202
`BriggsH@gtlaw.com
`Phone: (303) 572-6500
`Fax: (303) 572-6540
`
`
`
`
`
`
`
`
`IPR2018-01449
`
`U.S. Patent No. 9,299,467
`
`
`
`Patent Owner Sur-Reply
`
`CERTIFICATE OF COMPLIANCE
`WITH TYPE-VOLUME LIMITATION
`
`Pursuant to 37 C.F.R. §§ 42.24 et seq., the undersigned certifies that this
`
`Patent Owner Sur-Reply complies with the 5,600-word type-volume limitation. The
`
`Sur-Reply contains 2,871 words, excluding the parts of the Sur-Reply exempted.
`
`
`Dated: September 16, 2019
`
`
`
`
`
`
`
`/s/ Heath J. Briggs
`Heath J. Briggs (Reg. No. 54,919)
`GREENBERG TRAURIG, LLP
`1144 15th Street, Suite 3300
`Denver, CO 80202
`briggsh@gtlaw.com
`Phone: (303) 572-6500
`Fax: (303) 572-6540
`
`Counsel for Patent Owner Bracco
`Diagnostics Inc
`
`
`
`
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