`
`
`Filed: June 11, 2021
`
`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 RESPONSE
`UNDER 37 C.F.R. § 42.120
`
`
`

`

`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1 
`I. 
`LEVEL OF ORDINARY SKILL .................................................................... 2 
`II. 
`III.  OVERVIEW OF THE ’739 INVENTION ...................................................... 4 
`IV.  CHALLENGED CLAIMS .............................................................................. 7 
`V. 
`PROSECUTION HISTORY ........................................................................... 9 
`VI.  CLAIM CONSTRUCTION .......................................................................... 12 
`A. 
`“flares at both ends in a trumpet-like configuration” (claim 1) .......... 12 
`B. 
`“wherein the prosthetic heart valve is collapsed onto the pusher
`member” (claim 1) ............................................................................... 12 
`“valve means” (claim 1) ...................................................................... 19 
`C. 
`VII.  GROUND 1: PANIAGUA IS NOT PRIOR ART TO THE ’739
`PATENT AND SO DOES NOT ANTICIPATE THE CHALLENGED
`CLAIMS ........................................................................................................ 19 
`VIII.  GROUNDS 2-5: THE ’739 PATENT WOULD NOT HAVE BEEN
`OBVIOUS TO A PERSON OF ORDINARY SKILL IN THE ART IN
`VIEW OF BESSLER, KLINT, AND TEITELBAUM OR
`LEONHARDT ............................................................................................... 24 
`A.  Grounds 2-5: A POSA Would Not Have Started with Bessler ........... 24 
`B. 
`Grounds 2-3: Bessler in View of Leonhardt or Teitelbaum Does
`Not Disclose that “the prosthetic heart valve is collapsed onto
`the pusher member” ............................................................................. 30 
`1. 
`Bessler Does Not Disclose that “the prosthetic heart
`valve is collapsed onto the pusher member” ............................ 32 
`Bessler in View of Leonhardt Does Not Disclose that
`“the prosthetic heart valve is collapsed onto the pusher
`member” .................................................................................... 34 
`
`2. 
`
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`i
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`

`

`C. 
`
`3. 
`
`2. 
`
`2. 
`
`3. 
`
`E. 
`
`Bessler in View of Teitelbaum Does Not Disclose that
`“the prosthetic heart valve is collapsed onto the pusher
`member” .................................................................................... 39 
`Grounds 4-5: Bessler in View of Klint and Teitelbaum or
`Leonhardt Does Not Disclose that “the prosthetic heart valve is
`collapsed onto the pusher member” .................................................... 40 
`1. 
`Klint Does Not Disclose that “the prosthetic heart valve
`is collapsed onto the pusher member” ...................................... 40 
`A POSA Would Not Have Combined Bessler’s Heart
`Valve Device with Klint’s Pusher Member .............................. 45 
`D.  Grounds 2-5: A POSA Would Not Have Combined Bessler
`with Teitelbaum or Leonhardt to Achieve a “stent…that flares
`at both ends in a trumpet-like configuration” ..................................... 51 
`1. 
`A POSA Would Not Have Combined Bessler with
`Teitelbaum ................................................................................ 53 
`A POSA Would Not Have Combined Bessler with
`Leonhardt .................................................................................. 59 
`A POSA Would Not Have Combined Bessler and Klint
`with Teitelbaum or Leonhardt .................................................. 64 
`Grounds 4-5: Bessler in View of Klint and Teitelbaum and/or
`Leonhardt Does Not Disclose Claim 5’s “pusher member [that]
`includes a controlled release mechanism that can be activated” ........ 65 
`IX.  ADJUDICATION OF THE CHALLENGED PATENTS MAY
`VIOLATE THE U.S. CONSTITUTION ....................................................... 66 
`CONCLUSION .............................................................................................. 67 
`
`X. 
`
`
`
`
`
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`
`ii
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`

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`TABLE OF AUTHORITIES
`
`Cases 
`
`Abbott Labs. v. Dey, L.P.,
`287 F.3d 1097, 62 USPQ2d 1545 (Fed. Cir. 2002) ............................................. 18
`Apple Inc. v. Uniloc Luxembourg S.A.,
`IPR2017-02041 (PTAB Mar. 8, 2018) (Paper 10) ........................................ 31, 51
`
`Aro Mfg. Co., Inc. v. Convertible Top Replacement Co.,
`365 U.S. 336 (1961) ............................................................................................. 23
`e.Digital Corp. v. Futurewei Techs., Inc.,
`772 F.3d 723 (Fed. Cir. 2014) ....................................................................... 17, 18
`Envtl. Designs, Ltd. v. Union Oil Co. of California,
`713 F.2d 693 (Fed. Cir. 1983) ............................................................................3, 4
`G.B.T. Inc. v. Walletex Microelectronics Ltd.,
`IPR2018-00326 (PTAB June 25, 2019) (Paper 60) ............................................. 27
`
`Gillette Co. v. Energizer Holdings, Inc.,
`405 F.3d 1367 (Fed. Cir. 2005) ............................................................................ 23
`Goldenberg v. Cytogen, Inc.,
`373 F.3d 1158 (Fed. Cir. 2004) ..................................................................... 15, 18
`Housey Pharms., Inc. v. Astrazeneca UK Ltd.,
`366 F.3d 1348 (Fed. Cir. 2004) ............................................................................ 23
`In re Nordt Dev. Co., LLC,
`881 F.3d 1371 (Fed. Cir. 2018) ............................................................................ 22
`Innogenetics, N.V. v. Abbott Labs,
`512 F.3d 1363 (Fed. Cir. 2008) ............................................................................ 53
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004) ....................................................................... 21, 23
`Neutrino Dev. Corp. v. Sonosite, Inc.,
`410 F. Supp. 2d 529 (S.D. Tex. 2006) ................................................................... 4
`
`
`
`iii
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`

`

`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006) ............................................................................ 18
`Praxair, Inc. v. ATMI, Inc.,
`543 F.3d 1306 (Fed. Cir. 2008) ............................................................................ 22
`Texas Digital Sys., Inc. v. Telegenix, Inc.,
`308 F.3d 1193 (Fed. Cir. 2002) ............................................................................ 17
`Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n,
`805 F.2d 1558 (Fed. Cir.1986) ............................................................................. 21
`U.S. v. Arthrex, Inc., et al.,
`No. 19-1434, cert. granted, (Oct. 13, 2020) ........................................................ 67
`Vanguard Prods. Corp. v. Parker Hannifin Corp.,
`234 F.3d 1370 (Fed. Cir. 2000) ............................................................................ 22
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) ............................................................................ 23
`Winner Int’l Royalty Corp. v. Wang,
`202 F.3d 1340 (Fed. Cir. 2000) ..................................................................... 31, 51
`Rules 
`Manual of Patent Examining Procedure § 2113 ...................................................... 22
`Regulations 
`37 C.F.R. § 42.100(b) .............................................................................................. 12
`37 C.F.R. § 42.65(a) ................................................................................................. 27
`
`
`
`
`
`
`iv
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`I. INTRODUCTION
`Petitioners, challenging claims 1-5 of the ’739 patent, do not even attempt to
`
`explain how a POSA would approach the problems in the art solved by the ’739
`
`patent. Instead, Petitioners utilize hindsight to combine prior art references without
`
`regard for their field of study, and without mentioning the significant hurdles to be
`
`overcome by doing so. Petitioners fail to set forth even the most basic requirements
`
`to meet the burden of showing unpatentability due to obviousness: that a POSA
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`would have been motivated to combine two or more references with a reasonable
`
`expectation of success. Petitioners’ arguments must fail.
`
`Additionally, Petitioners have failed to demonstrate that the cited references
`
`render obvious every element of the Challenged Claims, including the
`
`requirements for a “prosthetic heart valve [that] is collapsed onto the pusher
`
`member,” a “stent member…that flares at both ends in a trumpet-like
`
`configuration,” and “a controlled release mechanism that can be activated.”
`
`Finally, Petitioners present a single anticipation ground—which the Board
`
`found unconvincing in its Institution Decision—that relies on a claim construction
`
`that violates black letter law by interpreting the patent’s claims, not based on the
`
`intrinsic evidence, but instead solely based on claim terms used in other, unrelated
`
`patents.
`
`
`
`1
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`

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`Accordingly, Patent Owner requests that the Board find Petitioners have
`
`failed to demonstrate that the Challenged Claims are unpatentable.
`
`II. LEVEL OF ORDINARY SKILL
`Patent Owner proposes the agreed-upon definition of a POSA set forth in a
`
`related IPR involving the ’739 patent at issue here (IPR2020-01454): A POSA as
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`of January 4, 2002 “would have had a minimum of either a medical degree and
`
`experience working as an interventional cardiologist or a Bachelor’s degree in
`
`bioengineering or mechanical engineering (or a related field) and approximately
`
`two years of professional experience in the field of percutaneously, transluminally
`
`implantable cardiac prosthetic devices. Additional graduate education could
`
`substitute for professional experience, or significant experience in the field could
`
`substitute for formal education.” (IPR2020-01454, Paper 1 at 23, Ex. 2019 ¶¶21-
`
`22.)
`
`Petitioners merely propose an unhelpful definition of a POSA in January of
`
`2002 as one who “would have been an interventional cardiologist with a working
`
`knowledge of heart valve designs, expandable stents, and intravascular stent
`
`delivery systems for stents [and] would, where necessary, work as a team in
`
`combination with a medical device engineer.” (Petition, 41-42.) However, the
`
`Federal Circuit has made clear that in analyzing a patent’s validity, “[t]he
`
`important consideration lies in the need to adhere to the statute, i.e., to hold that an
`
`
`
`2
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`

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`invention would or would not have been obvious, as a whole, when it was made, to
`
`a person of ‘ordinary skill in the art’—not to the judge, or to a layman, or to those
`
`skilled in remote arts, or to geniuses in the art at hand.” Envtl. Designs, Ltd. v.
`
`Union Oil Co. of California, 713 F.2d 693, 697 (Fed. Cir. 1983). Petitioners’
`
`proposed definition of a POSA does not allow for this required differentiation
`
`among those who possess ordinary skill in the art versus those who possess
`
`extraordinary skill in the art. Petitioners’ unhelpful definition cannot be accepted
`
`as including extraordinarily skilled artisans—who may view all inventions as
`
`obvious—within the definition of a POSA.
`
`Indeed, Petitioners’ expert, Dr. Goldberg, fell into the trap of opining as one
`
`of extraordinary skill in the art. At deposition, he testified that in forming his
`
`opinions, he applied all of his experience up until January 4, 2002, at which point
`
`he had been practicing in the relevant field for approximately 17 years by the
`
`relevant 2002 date at issue here, in contrast to the two years of experience required
`
`by the agreed upon definition of a person of skill in the art set forth in the related
`
`IPR2020-01454. (Ex. 2020, 20:5-14 (“Q. And the date that you’re talking about,
`
`the January 4th, 2002 date, what I’m trying to find out is if you applied all of your
`
`own qualifications and experience that you’ve listed in your declaration up until
`
`that date when [] reaching your opinions. [] A. Yes.”).) As such, Petitioners’ expert
`
`declaration is improper. See Neutrino Dev. Corp. v. Sonosite, Inc., 410 F. Supp. 2d
`
`
`
`3
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`

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`529, 550 (S.D. Tex. 2006) (“[I]f [the expert] testified based on his own perspective
`
`and that he possesses ‘extraordinary,’ not ordinary, skill in the art, then his
`
`conclusions are improper.” (citing Envtl. Designs, 713 F.2d at 697).
`
`Petitioners have also provided a definition of a person of ordinary skill in the
`
`art as of April 15, 2014, but as explained in detail in Section VII., below, the
`
`proper date to consider for the definition of a POSA is January 4, 2002.1 (Petition,
`
`41-42.)
`
`III. OVERVIEW OF THE ’739 INVENTION
`Heart disease is the leading cause of death in the United States. Over five
`
`million people in the U.S. are diagnosed with heart valve disease annually.
`
`Sometimes heart valve disease can be treated with medication, or the diseased
`
`heart valve can be repaired through surgery. In severe cases, however, the heart
`
`valve is so diseased that it cannot be treated by medication or repaired and must be
`
`
`1 January 2002 is the priority date for the ’739 patent and the filing date of the
`
`earliest application to which the ’739 patent claims priority as a continuation-in-
`
`part. (’739, Cover). However, the analysis does not change if a July 2004 date is
`
`used—which is the filing date of the earliest application to which the ’739 patent
`
`claims priority as a continuation. Petitioners also did not contest the January 2002
`
`priority date, other than with respect to Ground 1. (Petition, 41-42.)
`
`
`
`4
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`replaced with an artificial heart valve. Over 100,000 defective heart valves are
`
`replaced in the U.S. each year. The ’739 patent is directed to a percutaneous
`
`replacement heart valve and a delivery and implantation system. (’739, Cover.)
`
`PO Colibri was co-founded by Drs. David Paniagua and R. David Fish—the
`
`inventors of the ’739 patent. Drs. Paniagua and Fish, leading interventional
`
`cardiologists and innovators in the field of cardiovascular intervention, were
`
`responsible for one of the first percutaneous heart valve implants, and Dr. Paniagua
`
`performed the world’s first retrograde TAVI procedure on a human in 2003. (Ex.
`
`2001, 2-4.) Their work has resulted in the discovery and development of artificial
`
`heart valves and treatment methodologies that could offer patients an opportunity
`
`to receive a less invasive heart valve therapy, and became the basis for Colibri’s
`
`patented inventions.
`
`Colibri’s life-saving inventions include a patented, self-expanding heart
`
`valve device that includes cross-linked biological tissue and a delivery system that
`
`can be guided through a patient’s artery to the heart where it is positioned and used
`
`to replace diseased valves. The patented device and mechanism of controlled
`
`release, which includes making a small incision through which a thin, flexible tube
`
`is inserted into the artery, is far less invasive than open heart surgery. The
`
`controlled release capability permits a surgeon to recover the patented heart valve
`
`
`
`5
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`device during deployment. For this innovative replacement heart valve and system
`
`of delivery and implantation, Colibri was awarded the ’739 patent.
`
`Specifically, the claimed system of the ’739 patent is first directed to a
`
`prosthetic heart valve, which includes:
`
` A stent member that is collapsible, self-expanding, formed from
`
`nitinol, configured for transluminal percutaneous delivery, and
`
`includes a tubular structure away from a central portion that flares at
`
`both ends in a trumpet-like configuration; and
`
` A valve means that has two to four individual leaflets made of fixed
`
`pericardial tissue, resides entirely within an inner channel of the stent
`
`member, and has no reinforcing members residing within this inner
`
`channel. (’739, 14:5-15.)
`
`Next, the claimed system of the ’739 patent is directed to a delivery system
`
`(shown below), which includes:
`
`(’739, Fig. 8 (annotated).)
`
`
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`6
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` A pusher member with a guide wire lumen;
`
` The prosthetic valve collapsed onto the pusher member to reside (1)
`
`entirely within the inner channel of the stent member in a collapsed
`
`configuration on the pusher member, (2) or, upon deployment in the
`
`patient, to continue to reside in entirely within the inner channel of the
`
`stent member; and
`
` A moveable sheath (1) that has a lumen configured for the pusher
`
`member, (2) that restrains the valve in its collapsed configuration on
`
`the pusher member, (3) that has the distal end of the valve located at
`
`its distal end. (’739, 14:16-29.)
`
`IV. CHALLENGED CLAIMS
`Petitioners challenge claims 1-5 of the ’739 patent, of which claim 1 is
`
`independent.
`
`Claim 1 recites:
`
`An assembly to treat a native heart valve in a patient, the
`assembly for use in combination with a guidewire, the assembly
`comprising:
`a prosthetic heart valve including:
`a stent member having an inner channel, the stent
`member collapsible, expandable and configured for
`transluminal percutaneous delivery, wherein the stent member
`
`
`
`7
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`

`

`includes a tubular structure away from a central portion that
`flares at both ends in a trumpet-like configuration; and
`a valve means including two to four individual leaflets
`made of fixed pericardial tissue, wherein the valve means
`resides entirely within the inner channel of the stent member,
`and wherein no reinforcing members reside within the inner
`channel of the stent member;
`a delivery system including a pusher member and a moveable
`sheath, the pusher member including a guidewire lumen, wherein the
`pusher member is disposed within a lumen of the moveable sheath,
`wherein the prosthetic heart valve is collapsed onto the pusher
`member to reside in a collapsed configuration on the pusher member
`and is restrained in the collapsed configuration by the moveable
`sheath, wherein a distal end of the prosthetic heart valve is located at a
`distal end of the moveable sheath, and wherein the valve means
`resides entirely within the inner channel of the stent member in said
`collapsed configuration and is configured to continue to reside
`entirely within the inner channel of the stent member upon
`deployment in the patient.
`
`(’739, 14:2-29 (emphasis added).)
`
`Claim 2 recites:
`
`The assembly of claim 1, wherein the stent member is self-expanding.
`
`(Id., 14:30-31.)
`
`Claim 3 recites:
`
`The assembly of claim 2, wherein the stent member comprises nitinol.
`
`
`
`8
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`

`

`(Id., 14:32-33.)
`
`Claim 4 recites:
`
`The assembly of claim 1, wherein the stent member includes two
`circles of barbs on an outer surface of the stent member.
`
`(Id., 14:34-36.)
`
`Claim 5 recites:
`
`The assembly of claim 1, wherein the pusher member includes a
`controlled release mechanism that can be activated.
`(Id., 14:37-38.)
`
`V. PROSECUTION HISTORY
`The ’739 patent was filed on April 15, 2014, and claims the benefit of
`
`priority to application No. 10/887,688 (“the ’688 application”), filed on July 10,
`
`2004, as well as to application No. 10/037,266 (“the ’266 application”), filed on
`
`January 4, 2002, of which the ’688 application is a continuation-in-part. (’739,
`
`Cover.) The ’739 patent’s application was examined by Cheryl Miller, as was its
`
`sister application, which matured into U.S. Patent No. 8,900,294 (“the ’294
`
`patent). (Compare Ex. 1002, 508 with Ex. 2007, 1820.) During prosecution of the
`
`’294 patent, the Examiner considered and applied Leonhardt—the same reference
`
`at issue in Grounds 3 and 5 of this Petition. (Ex. 2007, 1816-20; Petition, 26.)
`
`In all material respects, the specification that Applicants filed on April 15,
`
`2014, is identical to the specification that Applicants filed in the ’688 Application
`
`
`
`9
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`

`on July 10, 2004. For example, both Applications contain the following disclosures
`
`in their “Description of Related Art’:
`
` Most tissue valves are constructed by sewing the leaflets of pig aortic
`
`valves to a stent to hold the leaflets in prior position, or by
`
`constructing valve leaflets from the pericardial sac of cows or pigs
`
`and sewing them to a stent.” (Ex. 1002, 23 ¶[0016]; Ex. 1018, 11
`
`¶[0015].)
`
` “Porcine and bovine pericardial valves not only require chemical
`
`preparation (usually involving fixation with glutaraldehyde), but the
`
`leaflets must be sutured to cloth-covered stents in order to hold the
`
`leaflets in position for proper opening and closing of the valve.
`
`Additionally, the leaflets of most such tissue valves are constructed by
`
`cutting or suturing the tissue material…” (Ex. 1002, 26 ¶[0022]; Ex.
`
`1018, 13 ¶[0021].)
`
`Both Applications also disclosed that Applicants’ invention contained
`
`multiple components, including a “Stent Member,” “Valve Means,” “Method of
`
`Making Replacement Heart Valve Device,” “Attachment of the Valve Means to
`
`the Stent Member,” and “Implantation of Replacement Heart Valve Device (Ex.
`
`1002, 31-41; Ex. 1018, 18-29.)
`
`
`
`10
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`

`

`On April 15, 2014, Applicants also filed a Preliminary Amendment in which
`
`they amended the title and claims of the priority document specification to reflect
`
`the aspect(s) of the specification’s disclosed invention being claimed in what
`
`matured into the ’739 patent. Specifically, in this Preliminary Amendment,
`
`Applicants (1) amended the title to: “Percutaneous Bioprosthetic Heart Valve and a
`
`Delivery and Implantation System,” (2) added that the application “is a
`
`continuation application of U.S. Patent Application No. 13/675,665 filed on
`
`November 13, 2012,” (3) fixed typos, and (4) recited the claims for the new
`
`application.
`
`Shortly thereafter, Applicants provided the Examiner with an IDS citing,
`
`among other references, U.S. Patent No. 5,855,601 to Bessler et al. and U.S. Patent
`
`No. 5,332,402 to Teitelbaum. (Ex. 1002, 157, 160.)
`
`As is relevant to this Petition, during prosecution of the ’739 patent, the
`
`Examiner rejected Applicants’ then-pending claims “as being unpatentable over
`
`Gabbay (US 2002/0032481 A1) in view of Garrison (US 6,425,916 B1),” and later
`
`over Yang et al. (US 6,733,525 B2) in view of Yang et al. (US 7,556,646 B2) and
`
`further in view of Gabbay (US 2002/0032481 A1, cited previously).” (Id., 237,
`
`390.) As discussed in Section VI.B. below, in response, Applicants made clear that
`
`a valve device next to a pusher member is not collapsed onto the pusher member.
`
`(Id., 238, 319, 291, 423-24.)
`
`
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`11
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`Challenged Claims 1-5 issued on September 8, 2015. (’739, Cover.)
`
`VI. CLAIM CONSTRUCTION
`The Challenged Claims are construed “using the same claim construction
`
`standard that would be used to construe the claim in a civil action under 35 U.S.C.
`
`§ 282(b).” 37 C.F.R. § 42.100(b) (Nov. 13, 2018). The ’739 patent claim terms are
`
`therefore construed “in accordance with the ordinary and customary meaning of
`
`such claim as understood by one of ordinary skill in the art and the prosecution
`
`history pertaining to the patent.” Id.
`
`Patent Owner agrees with Petitioners that, for purposes of this Response
`
`only, all terms of the ’739 patent, other than those specified below, have their plain
`
`and ordinary meaning.
`
`A. “flares at both ends in a trumpet-like configuration” (claim 1)
`In related district court litigation, the Technical Special Master construed
`
`“flares at both ends in a trumpet-like configuration” to mean “having, at each end,
`
`a widening that resembles the bell of a conventional musical trumpet.” (Ex. 2025,
`
`46.) Judge Carter adopted this construction. (Ex. 2026.) Patent Owner applies this
`
`definition to this proceeding. (Dasi ¶¶66-67.)
`
`B. “wherein the prosthetic heart valve is collapsed onto the pusher
`member” (claim 1)
`Petitioners have identified this element for construction, and argue that “the
`
`proper construction of ‘onto’ in the phrase ‘wherein the prosthetic heart valve is
`
`
`
`12
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`

`

`collapsed onto the pusher member,’ is ‘in contact with.’” (Petition, 37-41.)
`
`However, properly viewed in light of the ’739 patent specification, it is clear that
`
`“onto” in the phrase “wherein the prosthetic heart valve is collapsed onto the
`
`pusher member” does not mean “in contact with,” as the Board found in its
`
`Institution Decision. (Paper 8, 25.)
`
`Petitioners argue that the ’739 patent’s only disclosure of its “pusher
`
`member” “was copied nearly word-for-word from Bessler” such that “the ‘pusher
`
`member’ and the meaning of mounting the replacement heart valve device ‘onto’
`
`the ‘pusher member’ must be what Bessler teaches.” (Petition, 37-38.) Petitioners’
`
`argument fails for several reasons.
`
`First, while Bessler and the ’739 patent may use similar language to describe
`
`their respective pusher members, the Figures that they are describing make clear
`
`that they are not describing identical pusher members. (Dasi ¶72.) Rather, Bessler
`
`is disclosing a pusher member that is merely “in contact with” its prosthetic heart
`
`valve, whereas the ’739 patent is disclosing a prosthetic heart valve that is
`
`collapsed around its pusher member. (Dasi ¶¶70-72.)
`
`For example, the ’739 patent’s only description of its “pusher member” is
`
`used to describe its Figure 8 (annotated version copied below):
`
`
`
`13
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`

`
`
`In describing Figure 8’s pusher member, the ’739 patent discloses:
`
`[I]n FIG. 8[,]…the catheter 400…carries the replacement heart valve
`device of the present invention in its collapsed configuration…The
`catheter has a pusher member 420 disposed within the catheter 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, 11:44-51 (emphasis added).) Thus, the ’739 patent’s specification, read in
`
`conjunction with Figure 8 that it is describing, discloses that the ’739 patent’s
`
`pusher member 420 extends from the catheter’s proximal end (440) to its distal end
`
`(410), including through stent member (100)—which, along with its internally-
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`residing valve, are collapsed onto the pusher member. (Dasi ¶73.)
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`
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`By contrast, Bessler uses similar language to discuss its Figure 12 (annotated
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`version copied below):
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`14
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`In describing Figure 12’s pusher member, Bessler points to 93 at the distal end of
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`the catheter as the pusher member, and shows through Figure 12 that the pusher
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`member terminates prior to the proximal end of valve 92, as discussed above.
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`(Bessler, 7:26-35; Dasi ¶74.) Thus, despite the similar language used to describe
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`the pusher members in the ’739 patent and Bessler, that language refers to very
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`different figures, rendering Bessler’s pusher member discussion entirely irrelevant
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`to the construction of the ’739 patent’s claim language “the prosthetic heart valve
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`is collapsed onto the pusher member.” (Dasi ¶74.) See Goldenberg v. Cytogen,
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`Inc., 373 F.3d 1158, 1167 (Fed. Cir. 2004).
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`Second, during prosecution of the application that matured into the ’739
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`patent, Applicants confirmed that they intended “onto” in the phrase “wherein the
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`prosthetic heart valve is collapsed onto the pusher member” to mean something
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`other than “in contact with” as Petitioners argue. Specifically, during prosecution,
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`the Examiner stated that the reference Gabbay “does not disclose the valve to be
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`collapsed onto the pusher member (210 or 716), to reside in a collapsed
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`15
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`configuration on the pusher member” because “Gabbay’s pusher member 210 or
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`716 is a plunger member with lumen, ending proximately to the valve, which
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`pushes out the valve from behind.” (Ex. 1002, 238.) Applicants agreed, confirming
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`that, “[a]s stated by the Examiner on page 5 of the Office Action, ‘Gabbay does not
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`disclose the valve to be collapsed onto the pusher member (210 or 716), to reside
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`in a collapsed configuration on the pusher member.’” (Id., 319.)
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`Applicants reiterated their position when disagreeing with the Examiner’s
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`assertion that Yang ’646 discloses “that ‘the prosthetic heart valve (30) is collapsed
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`onto the pusher member to reside in a collapsed configuration on the pusher
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`member (fig. 1)’” (Id., 423-24.) Specifically, Applicants argued:
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`However, as can be seen in Fig. 1 of Yang ’646, the catheter shaft 24
`terminates proximal (to the right in Fig. 1) of the valve 30. Fig. 1 of
`Yang ’646 is reproduced below.
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`Accordingly, the expandable heart valve 30 cannot be collapsed onto
`the catheter shaft 24 because the catheter shaft carries stabilization
`balloon 36 and the catheter shaft 24 terminates proximally of the
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`16
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`valve 30. Indeed, Yang ’646 states “[t]he system may further include
`a stabilization balloon 36 provided on the catheter shaft 24 just
`proximal of the deployment mechanism 26.”
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`(Id., 424.)
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`Thus, in light of Applicants’ repeated statements during prosecution that the
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`prosthetic heart valve cannot be collapsed onto a pusher member that terminates
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`proximally to the valve, Petitioners’ proposed construction must fail. Petitioners’
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`construction of “collapsed onto” to mean “collapsed in contact with” specifically
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`includes “collapsed onto” a pusher member that terminates proximally to the valve
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`as in Bessler, which the prosecution history makes clear is not the meaning of
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`“collapsed onto.” (Dasi ¶¶75-77.)
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`Third, Petitioners cite no authority for their proposition that even similar
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`disclosures must be interpreted in the same way from Bessler to the unrelated ’739
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`patent. Indeed, Petitioners’ argument cannot be squared with “the well understood
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`notion that claims of unrelated patents must be construed separately.” e.Digital
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`Corp. v. Futurewei Techs., Inc., 772 F.3d 723, 727 (Fed. Cir. 2014). See also Texas
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`Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1211 (Fed. Cir. 2002) (holding
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`that a common inventor’s representation of “matrix displays and seven-segment
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`displays as two separate embodiments of the same invention” was irrelevant and
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`“sheds no light” on whether “the claims in an unrelated patent are broad enough to
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`encompass both a matrix and the familiar seven-segment pattern.”); Goldenberg,
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`17
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`373 F.3d at 1167 (noting that “this court’s precedent takes a narrow view on when
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`a related patent or its prosecution history is available to construe the claims of a
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`patent at issue and draws a distinct line between patents that have a familial
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`relationship and those that do not.”); Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d
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`1284, 1290 (Fed. Cir. 2006) (holding that statements made during prosecution of
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`the later, unrelated ’995 patent cannot be used to interpret claims of the ’893
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`patent).
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`Moreover, the fact that a portion of Bessler’s specification is incorporated
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`into that of the ’739 patent does not change the fact that the majority of the ’739
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`specification—including disclosures related to the pusher member—does not come
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`from Bessler. See e.Digital, 772 F.3d at 726–27 (holding that although “the ’108
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`patent may incorporate by reference the ’774 patent as prior art, it does not change
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`the fact that the patents are not related,” such that the ’774 patent may not be used
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`to construe the ’108 patent); Abbott Labs. v. Dey, L.P., 287 F.3d 1097, 1104, 62
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`USPQ2d 1545, 1550 (Fed. Cir. 2002) (finding the relationship between two
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`unrelated patents, although having common subject matter, a common inventor,
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`and the same assignee, “insufficient to render particular arguments made during
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`prosecution of [one of the patents] equally applicable to the claims of [the other
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`patent]”).
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`18
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`C. “valve means” (claim 1)
`In related district court litigation, the Technical Special Master construed
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`“valve” and “valve means” to mean “portions of the replacement heart valve
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`device that allow the one-way flow of blood.” (Ex. 2025, 15.) Judge Carter adopted
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`this construction. (Ex. 2026.) Patent Owner applies this definition to this
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`proceeding. (Dasi ¶¶78-79.)
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`VII. GROUND 1: PANIAGUA IS NOT PRIOR ART TO THE ’739
`PATENT AND SO DOES NOT ANTICIPATE THE CHALLENGED
`CLAIMS
`For Ground 1, Petitioners rely on the publication of the ’739 patent’s
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`grandparent application (Ex. 1015). (Petition, 42.) As the Board found in its
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`Institution Decision, because Petitioners have failed to show that the ’739 patent’s
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`claim to the priority date of its gra