Filed: October 22, 2021
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC,
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`PETITIONERS,
`
`V.
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`COLIBRI HEART VALVE LLC,
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`PATENT OWNER.
`
`___________________
`
`Case No. IPR2020-01649
`U.S. Patent No. 9,125,739
`___________________
`
`
`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC,
`
`PETITIONERS,
`
`V.
`
`COLIBRI HEART VALVE LLC,
`
`PATENT OWNER.
`
`___________________
`
`Case No. IPR2020-01649
`U.S. Patent No. 9,125,739
`___________________
`
`
`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY
`
`
`
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`I.
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`II.
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`B.
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`B.
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`TABLE OF CONTENTS
`GROUND 1: PETITIONER’S REPLY ADDS NOTHING TO THE
`PETITION’S PANIAGUA ARGUMENTS THAT THE BOARD
`ALREADY CONSIDERED AND REJECTED ............................................. 1
`GROUNDS 4-5: PETITIONER HAS FAILED TO SHOW THAT
`BESSLER/KLINT DISCLOSES CLAIM 5’S “CONTROLLED
`RELEASE MECHANISM THAT CAN BE ACTIVATED”. ........................ 4
`A.
`Petitioner Was Required to Allege How a Controlled Release
`Mechanism Would Work in Bessler/Klint ............................................ 4
`Petitioner Improperly Attempts to Allege How a Controlled
`Release Mechanism Would Work in Bessler/Klint for the First
`Time on Reply ....................................................................................... 7
`III. GROUNDS 2-5: “THE PROSTHETIC HEART VALVE IS
`COLLAPSED ONTO THE PUSHER MEMBER” DOES NOT
`MEAN THE PROSTHETIC HEART VALVE ONLY NEEDS TO BE
`“IN CONTACT WITH” THE PUSHER MEMBER. ................................... 10
`A.
`PO’s Construction of “collapsed onto the pusher member” is
`consistent with the intrinsic evidence ................................................. 12
`Petitioner’s allegations that all evidence conflicting with its
`proposed construction are erroneous ................................................... 15
`IV. GROUNDS 4-5: BESSLER/KLINT DOES NOT OBVIATE A
`“PROSTHETIC HEART VALVE [THAT] IS COLLAPSED ONTO
`THE PUSHER MEMBER.” .......................................................................... 19
`1.
`Klint Does Not Disclose that “the prosthetic heart valve
`is collapsed onto the pusher member” ...................................... 19
`A POSA Would Not Have Combined Bessler’s Heart
`Valve Device with Klint’s Pusher Member .............................. 22
`V. GROUNDS 2-5: LEONHARDT DOES NOT DISCLOSE THAT
`“THE PROSTHETIC HEART VALVE IS COLLAPSED ONTO
`THE PUSHER MEMBER”. .......................................................................... 24
`
`2.
`
`
`
`
`
`i
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`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`3M Innovative Properties Co. v. Tredegar Corp.,
`725 F.3d 1315 (Fed. Cir. 2013) ............................................................................ 22
`
`Aro Mfg. Co., Inc. v. Convertible Top Replacement Co.,
`365 U.S. 336 (1961) ............................................................................................... 3
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) .............................................................................. 21
`Chung v. Bed Bath & Beyond, Inc.,
`No. 3:09-cv-00330-DCG, 2011 WL 6967991 (W.D. Tex. Dec. 20,
`2011).............................................................................................................. 13, 18
`Edwards Lifesciences Corp. v. Colibri Heart Valve LLC,
`IPR2021-00775, Paper 1 (PTAB Apr. 6, 2021) ..................................................... 4
`Found. Med., Inc. v. Guardant Health, Inc.,
`IPR2019-00130, Paper 9 (PTAB Jan. 22, 2020) .................................................. 11
`Great West Casualty Co. et al. v. Intellectual Ventures II LLC,
`IPR2015-01706, Paper 69 (PTAB Feb. 14, 2020) ................................................. 8
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 12
`Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324 (Fed. Cir. 2019) .............................................................................. 8
`Hockerson-Halberstadt, Inc. v. Avia Grp. Int’l, Inc.,
`222 F.3d 951 (Fed. Cir. 2000) .............................................................................. 17
`Honeywell Int’l, Inc. v. United States,
`609 F.3d 1292 (Fed. Cir. 2010) .............................................................................. 2
`In re Power Integrations, Inc.,
`884 F.3d 1370 (Fed. Cir. 2018) ............................................................................ 21
`
`
`
`ii
`
`
`
`Merck & Co. v. Teva Pharm. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) ............................................................................ 21
`Metalcraft of Mayville, Inc. v. The Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) .............................................................................. 5
`Microsoft Corp. v. FG SRC, LLC,
`No. 2020-1928, 2021 WL 2461862 (Fed. Cir. June 17, 2021) .............................. 7
`MModal LLC v. Nuance Commc'ns, Inc.,
`846 F. App’x 900 (Fed. Cir. 2021) ...................................................................... 10
`Pers. Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................................5, 7
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .............................................................................. 1
`Praxair, Inc. v. ATMI, Inc.,
`543 F.3d 1306 (Fed. Cir. 2008) .............................................................................. 3
`Rembrandt Wireless Techs., LP v. Samsung Elecs. Co., Ltd.,
`853 F.3d 1370 (Fed. Cir. 2017) ....................................................................... 6, 19
`Rivera v. ITC,
`857 F.3d 1315 (Fed. Cir. 2017) .............................................................................. 2
`Wasica Fin. GmbH v. Cont'l Auto. Sys.,
`853 F.3d 1272 (Fed. Cir. 2017) ..........................................................................7, 8
`Zoltek Corp. v. United States,
`815 F.3d 1302 (Fed. Cir. 2016) .............................................................................. 1
`Other Authorities
`
`PTAB Trial Practice Guide (Nov. 2019) .......................................................... 11, 23
`
`
`
`
`
`
`iii
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`
`
`I. GROUND 1: PETITIONER’S REPLY ADDS NOTHING TO THE
`PETITION’S PANIAGUA ARGUMENTS THAT THE BOARD
`ALREADY CONSIDERED AND REJECTED
`Petitioner’s Reply repeats the same arguments that the Board already
`
`rejected and misapprehends the law’s written description requirements. “The
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`purpose of the written description requirement is to assure that the public receives
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`sufficient knowledge of the patented technology, and to demonstrate that the
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`patentee is in possession of the invention claimed.” Zoltek Corp. v. United States,
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`815 F.3d 1302, 1308 (Fed. Cir. 2016). This “requirement is applied in the context
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`of the state of knowledge at the time of the invention,” meaning that “[t]he written
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`description need not include information that is already known and available to the
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`experienced public.” Id. (quotation omitted). Because Petitioner has acknowledged
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`that “multi-piece leaflet valves were known in 2002,” the written description
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`requirement is satisfied. (Reply, 17.)
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`Regardless, Petitioner rehashes its failed argument that Paniagua’s
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`specification as of January 4, 2002 does not “describe[] using valve leaflets made
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`from multiple pieces in the invention.” (Reply, 17-18.) But Petitioner defines the
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`’739’s invention by the patent’s specification, despite the fact that “the claims of a
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`patent define the invention to which the patentee is entitled the right to exclude.”
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005). This is particularly
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`the case where the ’739 indicates that “[w]hile the present invention has been
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`
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`1
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`
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`shown and described herein in what is considered to be a preferred embodiment
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`thereof, illustrating the results and advantages over the prior art obtained through
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`the present invention, the invention is not limited to the specific embodiments
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`described above.” (’739, 13:30-38.) See Honeywell Int’l, Inc. v. United States, 609
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`F.3d 1292, 1301 (Fed. Cir. 2010) (reversing determination that claims to displays
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`other than CRTs lacked written description because “[w]hile original figure 3 may
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`have disclosed a CRT, there is no reason, in light of the other statements in the
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`specification, to limit the disclosure to only CRTs.”).
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`Rejecting this argument in its Institution Decision, the Board held that
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`“Petitioner cites no case law to support the notion that the ‘real distinction’
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`Petitioner recognizes is described in writing in the ’739 concerning how many
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`pieces are used to make an element of a claimed apparatus equates to a lack of
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`written description support for the apparatus.” (Paper 8, 42.) On Reply, Petitioner
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`still fails to provide any law that supports its failed theory. Indeed, Petitioner cites
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`only a single case related to Ground 1—Rivera v. ITC. (Reply, 19.) Rivera is
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`inapplicable here for two reasons.
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`First, the Federal Circuit distinguished Rivera from cases like this on the
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`basis that “nothing in the [] patent disclosure indicates the possibility of” the
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`element in question. Rivera v. ITC, 857 F.3d 1315, 1322 (Fed. Cir. 2017). Here, by
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`contrast, the specification provides “ample written disclosure of one piece leaflets
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`
`
`2
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`
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`and multiple piece leaflets,” as the Board found in its Institution Decision. (Paper
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`8, 43.)
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`Second, Rivera involved a single invention, and the evidence showed that
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`this invention would not work with the element in question. Rivera, 857 F.3d at
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`1321. Here, by contrast, the ’739 patented invention contains multiple components.
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`(Ex. 1002, 31-41; Ex. 1018, 18-29.) And unlike in Rivera, Petitioner has provided
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`no evidence that any of these inventive components—including those recited in the
`
`claims—would not work with the multiple piece leaflets that the patent discloses.
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`Rather, the ’739’s Applicants invented, enabled, and described multiple
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`components of a delivery system, each with its own advantages or purposes. And
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`where an invention “possess[es] a number of advantages or purposes, [] there is no
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`requirement that every claim directed to that invention be limited to encompass all
`
`of them.” See Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1325 (Fed. Cir. 2008).
`
`See Aro Mfg. Co., Inc. v. Convertible Top Replacement Co., 365 U.S. 336, 345
`
`(1961) (no legally recognizable or protected “essential” element, “gist” or “heart”
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`of the invention in a combination patent).
`
`
`
`3
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`
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`II. GROUNDS 4-5: PETITIONER HAS FAILED TO SHOW THAT
`BESSLER/KLINT DISCLOSES CLAIM 5’S “CONTROLLED RELEASE
`MECHANISM THAT CAN BE ACTIVATED”.
`A. Petitioner Was Required to Allege How a Controlled Release
`Mechanism Would Work in Bessler/Klint
`Petitioner fails to address the claim 5 controlled release mechanism in its
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`discussion of Grounds 4-5 in the Petition. (Petition, 66-70.) As the POR explains, a
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`POSA1 would have understood that a device made from the combination of Bessler
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`and Klint would not have any mechanism for controlled release, as Bessler’s
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`threads/sutures looped through an opening in its pusher member—and necessary
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`for controlled release—would be substituted Klint’s pusher member, which does
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`not have an opening for Bessler’s sutures. (POR, 65-66.) Because the Petition was
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`silent as to how, if at all, a POSA might modify Petitioner’s proposed Bessler/Klint
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`combination to include a “pusher member [that] includes a controlled release
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`
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`1 Petitioner advocates for the definition of a POSA submitted in the Petition.
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`(Reply, 26.) However, in IPR2021-00775, Petitioner submitted a Petition
`
`proposing the exact POSA definition PO proposes in the POR. Edwards
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`Lifesciences Corp. v. Colibri Heart Valve LLC, IPR2021-00775, Paper 1, 21-22
`
`(PTAB Apr. 6, 2021).
`
`
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`4
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`
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`mechanism that can be activated,” Petitioner’s allegations regarding claim 5 in the
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`Bessler/Klint combination must fail.
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`On Reply, Petitioner argues that it was not required to explain in the Petition
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`how Petitioner’s proposed combination of art work would. (Reply, 15.) Not so. See
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`e.g., Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir.
`
`2017) (“Without any explanation as to how or why the references would be
`
`combined to arrive at the claimed invention, we are left with only hindsight bias
`
`that KSR warns against…we cannot allow hindsight bias to be the thread that
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`stitches together prior art patches into something that is the claimed invention.”).
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`Specifically, Petitioner argues that PO is “wrong on the law” because “the
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`obviousness inquiry does not ask ‘whether the references could be physically
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`combined but whether the claimed inventions are rendered obvious by the
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`teachings of the prior art as a whole.’” (Reply, 15.)
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`That is not so here, where Petitioner filed a Petition for IPR, and 35 U.S.C.
`
`§ 312(a)(3) requires Petitioner—in its Petition—to identify “with particularity,
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`…the grounds on which the challenge to each claim is based,” including how
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`Petitioner’s proposed combination of art would work. See Pers. Web Techs., LLC
`
`v. Apple, Inc., 848 F.3d 987, 994 (Fed. Cir. 2017) (reversing Board where “the
`
`Board nowhere clearly explained, or cited evidence showing, how the combination
`
`of the two references was supposed to work” because “a clear, evidence-supported
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`
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`5
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`
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`account of the contemplated workings of the combination is a prerequisite to
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`adequately explaining and supporting a conclusion that a [POSA] would have been
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`motivated to make the combination and reasonably expect success in doing so.”).
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`Further, Petitioner explicitly alleged that a POSA would have physically combined
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`Bessler with Klint in “a simple substitution of one known prior art delivery system
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`element (a pusher member adjacent to the collapsed prosthesis) with another (a
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`pusher member that extends through the interior of the collapsed prosthesis).”
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`(Petition, 69 (emphasis added).)
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`Petitioner also argues that a POSA would have known that Bessler/Klint
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`could be successfully combined because “there is no suggestion that Bessler’s
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`pusher member and controlled release sutures could not be combined with Klint’s
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`pusher member, or that the resulting system could not be adapted to include
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`locations to secure the sutures taught by Bessler if Bessler’s pusher member is
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`replaced by Klint’s pusher member.” (Reply, 15 (citing POR, 65-66.) But the fact
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`that Bessler/Klint does not teach away from this modification does not equate to a
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`POSA being motivated to make this modification—something Petitioner has never
`
`alleged. See Rembrandt Wireless Techs., LP v. Samsung Elecs. Co., Ltd., 853 F.3d
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`1370, 1379–80 (Fed. Cir. 2017) (“Whether a reference teaches away is doctrinally
`
`distinct from whether there is no motivation to combine prior art references…[T]he
`
`absence of a formal teaching away in one reference does not automatically
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`
`
`6
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`
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`establish a motivation to combine it with another reference in the same field.”);
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`Microsoft Corp. v. FG SRC, LLC, No. 2020-1928, 2021 WL 2461862, at *4 (Fed.
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`Cir. June 17, 2021) (“It is not the Board's job to cobble together assertions from
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`different sections of a petition or citations of various exhibits in order to infer
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`every possible permutation of a petitioner's arguments. Arguments in a petition
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`must be made with particularity, not opacity…”). Indeed, “[s]hifting arguments in
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`this fashion is foreclosed by statute, [Federal Circuit] precedent, and Board
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`guidelines.” Wasica Fin. GmbH v. Cont'l Auto. Sys., 853 F.3d 1272, 1285–87 (Fed.
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`Cir. 2017) (collecting citations).
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`B. Petitioner Improperly Attempts to Allege How a Controlled Release
`Mechanism Would Work in Bessler/Klint for the First Time on Reply
`The Petition having failed to “clearly explain[], or cite[] evidence showing,
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`how the combination of the two references was supposed to work,” Petitioner
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`improperly attempts to provide this explanation on Reply. See Pers. Web, 848 F.3d
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`at 994. Specifically, Petitioner now argues that a POSA would have modified
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`Bessler/Klint “to include holes (or another attachment means) in the pusher
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`member taught by Klint so that Bessler’s sutures could be looped through.” (Reply,
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`16 (citations omitted).)” Petitioner’s argument fails for multiple reasons.
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`First, Petitioner argues that a POSA would have been able to use its
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`creativity to figure out how to modify Bessler/Klint to work. (Id.) But Petitioner’s
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`argument misses the point that Petitioner was required to identify how a POSA
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`
`
`7
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`
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`would have made the Bessler/Klint combination work in its Petition. Having failed
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`to do so, Petitioner has waived this argument on Reply. See Wasica, 853 F.3d at
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`1285–87 (affirming Board’s ruling that an obviousness challenge was
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`“insufficiently precise and underdeveloped” because petitioner “did not make out
`
`its obviousness case in its petition” and the reply argued that a relevant artisan
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`would have looked to a different passage and would have modified the prior art.);
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`Great West Casualty Co. et al. v. Intellectual Ventures II LLC, IPR2015-01706,
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`Paper 69, 23 (PTAB Feb. 14, 2020) (“Petitioner should not be permitted to do a
`
`hindsight rearrangement of its Petition in this manner. Most prominently, the
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`Petition does not propose any modifications to MyLibrary to meet the limitations
`
`recited in dependent claim 14 until its Reply. That is facially improper.” (citing
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`Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1330–31 (Fed. Cir. 2019)
`
`(“an IPR petitioner may not raise in reply ‘an entirely new rationale’ for why a
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`claim would have been obvious.”))).
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`Had Petitioner made this allegation—as required—in the Petition, PO could
`
`have responded with evidence demonstrating that a POSA would not believe
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`Petitioner’s belated suggestion of “includ[ing] holes (or other attachment means)”
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`would have worked. But the fact that PO is prohibited from providing new
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`evidence on sur-reply to counter this argument is why APA/due process
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`requirements prohibit Petitioner from making this new argument on Reply. See
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`
`
`8
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`
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`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed.
`
`Cir. 2016) (“It is of the utmost importance that petitioners in the IPR proceedings
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`adhere to the requirement that the initial petition identify ‘with particularity’ the
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`evidence that supports the grounds for the challenge to each claim…Unlike district
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`court litigation—where parties have greater freedom to revise and develop their
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`arguments over time and in response to newly discovered material—the expedited
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`nature of IPRs bring[s] with it an obligation for petitioners to make their case in
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`their petition to institute. While the Board’s requirements are strict ones, they are
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`requirements of which petitioners are aware when they seek to institute an IPR.”).
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`Second, Petitioner also improperly attempts to provide evidence in support
`
`of this proposed modification for the first time on Reply. Specifically, Petitioner
`
`argues that “Klint itself explains that ‘projections, hooks, ridges, or another kind
`
`of engagement means such as a high friction material’ can be used, and another
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`embodiment of Klint’s invention (for an embolization device), explicitly describes
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`use of ‘two mating parts held together by a thread that can be pulled out for
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`detachment of the embolization device’ and explains that ‘[t]hese kinds of
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`connection means are well known in the art…” (Reply, 16 (citations omitted).)
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`Petitioner did not cite to either of these portions of Klint to explain how
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`Bessler/Klint could have a “pusher member [that] includes a controlled release
`
`mechanism that can be activated,” and so cannot do so now. MModal LLC v.
`
`
`
`9
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`
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`Nuance Commc'ns, Inc., 846 F. App’x 900, 906 (Fed. Cir. 2021) (“A petitioner
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`generally must provide in the petition an understandable explanation of the
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`element-by-element specifics of the unpatentability challenges, including the
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`particular portions of prior art supporting those challenges.”) (emphasis added).
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`Moreover, Petitioner has never alleged that Klint teaches a controlled release
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`mechanism, so Petitioner’s allegations fail in this respect. (See Petition, 66-70
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`(never discussing controlled release with respect to Klint).)
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`Third, Petitioner acknowledges its reliance on a portion of Klint that comes
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`from “another embodiment of Klint’s invention (for an embolization device).” But
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`Petitioner does not allege that Klint’s embolization device teaches a controlled
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`release mechanism. (See Reply, 16.) Moreover, Petitioner has provided no
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`rationale for combining Klint’s embolization device embodiment with the
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`prosthesis delivery system embodiment upon which the Petition relies—running
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`afoul of the Federal Circuit’s directive against “combining multiple embodiments
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`from a single reference” without “a motivation to make the combination.” See In re
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`Stepan Co., 868 F.3d 1342, n1 (Fed. Cir. 2017).
`
`III. GROUNDS 2-5: “THE PROSTHETIC HEART VALVE IS
`COLLAPSED ONTO THE PUSHER MEMBER” DOES NOT MEAN
`THE PROSTHETIC HEART VALVE ONLY NEEDS TO BE “IN
`CONTACT WITH” THE PUSHER MEMBER.
`In its Petition, Petitioner took the position that “the proper construction of
`
`‘onto’ in the phrase ‘wherein the prosthetic heart valve is collapsed onto the pusher
`
`
`
`10
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`
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`member,’ is ‘in contact with.’” (Petition, 41.) Notably, Petitioner provided a
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`singular reason for its construction: “the meaning of mounting the replacement
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`heart valve device ‘onto’ the ‘pusher member’ must be what Bessler teaches…[,
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`which is that] the replacement heart valve [] is just distal to, and is in contact with,
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`the pusher member…” (Petition, 38.) In its Institution Decision, the Board
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`correctly rejected Petitioner’s argument. (Paper 8, 25-27.) On Reply, Petitioner has
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`abandoned its Bessler-based rationale, and instead introduces a new argument
`
`based on a mischaracterization of the record. The Trial Practice Guide does not
`
`permit Petitioner to rely on this new intrinsic and/or extrinsic evidence in support
`
`of its construction on Reply. (Trial Practice Guide (Nov. 2019), 44-45 (“If a
`
`petitioner believes that a claim term requires an express construction, the petitioner
`
`must include a statement identifying a proposed construction of the particular term
`
`and where the intrinsic and/or extrinsic evidence supports that meaning…The
`
`petitioner may respond to any such new claim construction issues raised by the
`
`patent owner, but cannot raise new claim construction issues that were not
`
`previously raised in its petition.”) (emphasis added).) Petitioner’s new claim
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`construction arguments fail for this reason alone. See Found. Med., Inc. v.
`
`Guardant Health, Inc., IPR2019-00130, Paper 9, 6-7 (PTAB Jan. 22, 2020) (claim
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`construction is subject to the “particularity requirements of 35 U.S.C. § 312(a) and
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`37 C.F.R. § 42.104(b)”) (citing Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356,
`
`
`
`11
`
`
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`1363 (Fed. Cir. 2016) (“In an IPR, the petitioner has the burden from the onset to
`
`show with particularity why the patent it challenges is unpatentable.”)).
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`Petitioner supports its rejected claim construction by arguing that the
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`intrinsic evidence contains at least seven separate errors—five of which Petitioner
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`alleges for the first time on Reply—that, when all selectively ignored, allegedly
`
`render Petitioner’s proposed construction a plausible one. In essence, the
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`Institution Decision and POR made clear that Petitioner’s construction cannot be
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`squared with the ’739’s Figure 8, and so Petitioner now argues (1) that Figure 8
`
`contains errors and (2) that because of these errors, the entirety of Figure should be
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`ignored in favor of a selective reading of the specification and while completely
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`ignoring the prosecution history. Petitioner is wrong on both counts.
`
`A. PO’s Construction of “collapsed onto the pusher member” is consistent
`with the intrinsic evidence
`Figure 8 does not contain the errors Petitioner alleges, as PO will
`
`demonstrate below. However, even if Figure 8 did contain these errors, that is
`
`irrelevant because the overall understanding of a “prosthetic heart valve [that] is
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`collapsed onto the pusher member” that a POSA would gain through a review of
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`the intrinsic evidence is consistent with PO’s depiction of Figure 8, and cannot be
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`squared with Petitioner’s proposed construction of a “prosthetic heart valve [that]
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`is collapsed onto the pusher member.”
`
`
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`12
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`
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`Petitioner selectively cites an unpublished district court case footnote to
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`argue that “[w]hen a patent figure contains obvious errors, the figure can be
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`disregarded and the other portions of the intrinsic evidence can be relied on
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`instead.” (Reply, 21-22.) But what the cases in this footnote actually say is not that
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`a party may choose to throw out a figure with a purported error entirely, but
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`instead that a POSA should look to “gain[] an overall understanding of the total
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`substance” of the teachings, “grounded in the intrinsic evidence,” without “giv[ing]
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`effect to the erroneous aspect of the figure.” See Chung v. Bed Bath & Beyond,
`
`Inc., No. 3:09-cv-00330-DCG, 2011 WL 6967991, at *5, n.50 (W.D. Tex. Dec. 20,
`
`2011) (emphasis added).
`
`As the POR explains, the ’739’s specification describes the pusher member
`
`as follows: “The catheter has a pusher member 420 disposed within the catheter
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`lumen 430 and extending from the proximal end 440 of the catheter to the
`
`hollow section at the distal end 410 of the catheter.” (’739, 11:48-51 (emphasis
`
`added); POR, 12-18.) The POR provided an annotated illustration of Figure 8 to
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`highlight the stent member and pusher member as described in the specification.2
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`In this illustration (copied below), the POR showed in blue what the specification
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`
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`2 Contrary to Petitioner’s insinuation that PO attempted to mislead the Board by
`adding labels and colors to Figure 8, the POR plainly labelled this figure as an
`“annotated version” of Figure 8. (POR 13-14.)
`
`
`
`13
`
`
`
`describes as the pusher member: 420—which in this Figure consists of a hollow
`
`nose cone (containing guidewire 450) on one side of the stent member attached to
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`a hollow tube (also containing guidewire 450) that extends from the 440 end of the
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`catheter to the hollow section at the 410 end of the catheter.
`
`
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`This depiction is consistent with the specification’s labeling of Figure 8, as well as
`
`with the patent’s prosecution history. Although Petitioner asserts that Figure 8
`
`“contains obvious errors” and so “can be disregarded and the other portions of the
`
`intrinsic evidence can be relied on instead,” on Reply, Petitioner omits any
`
`discussion of the intrinsic evidence found in the prosecution history—which is
`
`consistent with PO’s depiction of Figure 8 and construction of a “prosthetic valve
`
`[that] is collapsed onto the pusher member.” (Reply, 21 (emphasis added).)
`
`As the POR explains, and the Board correctly found in its Institution
`
`Decision, “statements in the prosecution history of the ’739 patent (which
`
`
`
`14
`
`
`
`Petitioner addressed [in the Petition] and seemed to dismiss as associated with
`
`some sort of Examiner error) make clear that the purported invention was
`
`distinguished over prior art that merely showed a pusher member in contact with a
`
`prosthetic valve.” (Paper 8, 26 (citing POPR, 18-19 (citing Ex. 1002, 238, 319));
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`POR, 15-17.) Thus, it would be clear to a POSA reading all of the extrinsic
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`evidence, that for a prosthetic heart valve to be “collapsed onto the pusher
`
`member,” it is not sufficient for the prosthetic valve merely to be “in contact with”
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`the pusher member as Petitioner alleges.
`
`B. Petitioner’s allegations that all evidence conflicting with its proposed
`construction are erroneous
`Regardless, Petitioner alleges that all intrinsic evidence in conflict with its
`
`proposed construction consists of “obvious errors.” (Reply, 19-22.) To say
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`Petitioner’s allegation of seven separate errors is a stretch is an understatement.
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`Rather, the simplest explanation—offered by PO and accepted by the Board in its
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`Institution Decision—is the correct one. Regardless, PO will address each of
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`Petitioner’s litany of alleged errors in turn. The errors that Petitioner alleges and
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`PO’s responses are below:
`
` (1) the Examiner erred during prosecution when she distinguished Gabbay
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`from the ’739 because Gabbay’s valve is next to and in contact with, but not
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`“collapsed onto the pusher member” (Petition, 39).
`
`
`
`15
`
`
`
` (2) applicants “took their failure to correct the Examiner’s error one step
`
`further,” and also distinguished the ’739 from Yang because Yang’s valve is
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`next to and in contact with, but not “collapsed onto the pusher member”
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`(Petition, 39-40).
`
`(1) and (2) are the only “errors” alleged in the Petition instead of for the first
`
`time on Reply. However, the Board correctly found in its Institution Decision that
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`the ’739’s prosecution history “make[s] clear that the purported invention was
`
`distinguished over prior art that merely showed a pusher member in contact with a
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`prosthetic valve,” despite the Petition’s dismissal of these statements “as associated
`
`with some sort of Examiner error.” (Paper 8, 26.)
`
` (3) Figure 8 labels the conical structure (element 420) as the “pusher
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`member” when it is a nose cone (Reply, 21).
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`Petitioner attempts to discredit PO’s expert for labeling 420 as both the
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`pusher member and a nose cone, but as PO’s expert explained at deposition, these
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`two are not mutually exclusive. (See Ex. 1039, 46:3-47:20, 61:14-22.)
`
` (4) PO erroneously “re-casts” element 430 (“catheter lumen) as part of 420
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`(Reply, 20).
`
`This is false, as PO’s expert repeatedly explained during deposition. (See
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`Ex. 1039, 47:21-53:21, 55:4-56:5.) While PO acknowledges that it is unclear what
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`430 points to in Figure 8, the patent’s specification indicating that 430 is the
`
`
`
`16
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`
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`catheter lumen would make clear to a POSA that 430 points to the empty space in
`
`the hollow portion of the catheter. And the law makes clear that a POSA would
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`rely on the specification to clarify ambiguity in patent drawings. See Hockerson-
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`Halberstadt, Inc. v. Avia Grp. Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000)
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`(“Under our precedent, however, it is well established that patent drawings do not
`
`define the precise proportions of the elements and may not be relied on to show
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`particular sizes if the specification is completely silent on the issue.”).
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` (5) PO erroneously “re-casts” element 410 (“a flexible hollow tube
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`catheter”) as part of 420. (Reply, 20.)
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` (6) Element 410 is defined in the specification as the “distal end 410 of the
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`catheter” and in another portion as the “flexible hollow tube catheter.”
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`(Reply, 21.)
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`For (5) and (6), Petitioner is wrong, as PO’s expert explained during his
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`deposition. (See Ex. 1039, 55:4-61:8.) The specification explains that all of Figure
`
`8 is a depiction of “catheter 400,” which is a “flexible hollow tube catheter”—
`
`which includes elements such as a pusher member 420, a catheter lumen 430, a
`
`stent member 100, etc. (’739, 11:40-51.) According to the specification, 410 is
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`merely used to indicate one end of this catheter 400 to which the pusher member
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`420 extends (through the prosthetic valve to the side of the valve opposite the
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`“nose cone”). (Id., 11:48-55.) Also, (6) is an alleged error in the specification text
`
`
`
`17
`
`
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`and not in Figure 8, and so does not help Petitioner’s point that Figure 8 should be
`
`disregarded in favor of the specification’s text.
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` (7) Figure 8 labels the distal-most portion of the catheter as the “proximal
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`end” of the catheter. (Reply, 21.)
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`It is the specification text that discusses “the proximal end 440 of the
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`catheter,” so this does not help Petitioner’s point that Figure 8 should be
`
`disregarded in favor of the specification’s text. And while PO agrees that the
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`specification’s text inverted the labels of proximal and distal, in light of the
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`additional intrinsic evidence discussed above, a POSA looking to “gain[] an
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`overall understanding of the substance” of the patent’s teachings, “grounded in the
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`intrinsic evidence,” without “giv[ing] effect to the erroneous aspect” of the
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`teachings would understand that this inversion was a clerical error, with Figure 8’s
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`440 being the distal end of the catheter and 410 being the proximal end of the
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`catheter. See Chung, 2011
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