Trials@uspto.gov
`571-272-7822
`
`Paper 26
`Entered: March 24, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`v.
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`
`IPR2020-01649
`Patent 9,125,739 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JAMES A. TARTAL, and
`ERIC C. JESCHKE, Administrative Patent Judges.
`TARTAL, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
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`IPR2020-01649
`Patent 9,125,739 B2
`We have jurisdiction to conduct this inter partes review
`under 35 U.S.C. § 6. This Final Written Decision is issued pursuant
`to 35 U.S.C. § 318(a) (2018) and 37 C.F.R. § 42.73 (2020). For the reasons
`discussed below, we determine Edwards Lifesciences Corporation and
`Edwards Lifesciences LLC (“Petitioner”)1 has shown by a preponderance of
`the evidence that claims 1–5 (“the Challenged Claims”) of U.S. Patent
`No. 9,125,739 B2 (Ex. 1001, “the ’739 patent”) are unpatentable.
`I. INTRODUCTION
`A. Summary of Procedural History
`Petitioner filed a Petition pursuant to 35 U.S.C. §§ 311–319
`requesting an inter partes review of the Challenged Claims. Paper 2
`(“Pet.”). We instituted an inter partes review of the Challenged Claims on
`all grounds of unpatentability asserted in the Petition. Paper 8 (“Inst. Dec.”).
`Colibri Heart Valve LLC (“Patent Owner”)2 filed a Patent Owner Response.
`Paper 14 (“Resp.”). Petitioner filed a Reply to the Patent Owner Response.
`Paper 18 (“Reply”). Patent Owner filed a Sur-reply in support of the Patent
`Owner Response. Paper 19 (“Sur-reply”).
`Following oral argument, we entered a transcript of the hearing in
`the record. Paper 25. Petitioner bears the burden of proving unpatentability
`of each claim it has challenged by a preponderance of the evidence, and the
`burden of persuasion never shifts to Patent Owner. See 35 U.S.C. § 316(e)
`(2018); 37 C.F.R. § 42.1(d); Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`
`1 Petitioner identifies no additional real parties in interest. Pet. 24.
`2 Patent Owner identifies no additional real parties in interest. Paper 4, 1.
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`IPR2020-01649
`Patent 9,125,739 B2
`
`B. Related Matters
`The ’739 patent is also challenged in Medtronic CoreValve LLC,
`Edwards Lifesciences Corp., and Edwards Lifesciences LLC v. Colibri
`Heart Valve LLC, IPR2020-01454 (filed September 2, 2020) (“the 01454-
`IPR”), in which a final written decision is issued contemporaneous with this
`Decision. The parties identify the ’739 patent as a subject of Colibri Heart
`Valve LLC v. Medtronic CoreValve LLC, No. 8:20-cv-847 (C.D. Cal., filed
`May 4, 2020) (the “CDCA Case”) to which Petitioner is not a party.
`Pet. 24–25; Paper 4, 1. In addition to the ’739 patent, U.S. Patent
`No. 8,900,294 (“the ’294 patent”) is also a subject of the CDCA Case. The
`’739 patent and the ’294 patent each issued from applications that are
`continuations of U.S. Application No. 13/675,665, and have substantially the
`same specification. The ’294 patent was challenged in a petition for inter
`partes review that was denied. Colibri Heart Valve LLC v. Medtronic
`CoreValve LLC, IPR2020-01453, Paper 11 (PTAB Mar. 5, 2021).
`C. The ’739 Patent
`The ’739 patent, titled “Percutaneous Replacement Heart Valve and
`a Delivery and Implantation System,” issued September 8, 2015, from
`Application No. 14/253,650 (“the ’650 Application”), filed April 15, 2014,
`which claims priority back to Application No. 10/037,266, filed on
`January 4, 2002. Ex. 1001, codes (21), (22), (45), (54), (63). The
`replacement heart valve device described by the ’739 patent “comprises
`a stent made of stainless steel or self-expanding nitinol and a completely
`newly designed artificial biological tissue valve disposed within the inner
`space of the stent.” Id. at 4:64–5:1.
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`IPR2020-01649
`Patent 9,125,739 B2
`Figure 5 of the ’739 patent is reproduced below.
`
`
`Figure 5 illustrates a side view of a replacement heart valve device mounted
`within a self-expanding stent in the expanded position. Id. at 6:31–34. “The
`replacement heart valve device comprises a stent member 100 and a flexible
`valve means 200.” Id. at 6:55–57. “The stent member 100 includes a length
`of wire 110 formed in a closed zigzag configuration.” Id. at 7:32–33. The
`stent member may be a meshwork of nitinol wire formed into a tubular
`structure that “flares markedly at both ends in a trumpet-like configuration.”
`Id. at 7:55–63. The “trumpet-like configuration” is not illustrated in
`Figure 5, or in any other figure of the ’739 patent.
`
`The valve means comprises “a generally tubular portion” and,
`“preferably, a peripheral upstanding cusp or leaflet portion.” Id. at 6:61–64.
`The valve means is “flexible, compressible, host-compatible, and non-
`thrombogenic.” Id. at 8:27–28. It may be made from various materials,
`preferably mammal pericardium tissue. Id. at 8:28–35. The cusp or leaflet
`portion of the valve means is generally tubular in shape and comprises two
`to four leaflets. Id. at 7:5–8. The cusp or leaflet portion of the valve means
`is “formed by folding the pericardium material used to create the valve.” Id.
`at 8:44–46. “The starting material is preferably a flat dry sheet, which can
`be rectangular or other shaped.” Id. at 8:47–49. The cusps/leaflets “open in
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`IPR2020-01649
`Patent 9,125,739 B2
`response to blood flow in one direction and close in response to blood flow
`in the opposite direction.” Id. at 8:49–51.
`
`Figure 8 of the ’739 patent is reproduced below.
`
`
`Figure 8 illustrates the “delivery and implantation system of the replacement
`artificial heart valve,” including “flexible catheter 400 which may be
`inserted into a vessel of the patient and moved within that vessel.” Id.
`at 11:40–44. The ’739 patent further explains as follows:
`The distal end 410 of the catheter 400, which is hollow and
`carries the replacement heart valve device of the present
`invention in its collapsed configuration, is guided to a site where
`it is desired to implant the replacement heart valve. 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. Once the
`distal end 410 of the catheter is positioned as desired, the pusher
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`IPR2020-01649
`Patent 9,125,739 B2
`mechanism 420 is activated and the distal portion of the
`replacement heart valve device is pushed out of the catheter and
`the stent member 100 partially expands. In this position the stent
`member 100 is restrained so that it doesn't pop out and is held for
`controlled release, with the potential that the replacement heart
`valve device can be recovered if there is a problem with the
`positioning. The catheter 400 is then retracted slightly and the
`replacement heart valve device is completely pushed out of the
`catheter 400 and released from the catheter to allow the stent
`member 100 to fully expand.
`Id. at 11:44–62.
`
`D. Illustrative Claims of the ’739 Patent
`Petitioner challenges claims 1–5 (all claims) of the ’739 patent.
`Pet. 1. Claim 1 is independent and claims 2–5 depend from claim 1.
`Ex. 1001, 14:2–38. Claims 1 and 5 are illustrative of the claimed subject
`matter and are reproduced below.
`1. 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 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
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`IPR2020-01649
`Patent 9,125,739 B2
`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.
`Id. at 14:2–29.
`5. The assembly of claim 1, wherein the pusher member
`includes a controlled release mechanism that can be activated.
`Id. at 14:37–38.
`
`E. References and Testimony
`Below we provide an abbreviated summary of the qualifications of
`Steven L. Goldberg, M.D., who provides testimony in support of Petitioner,
`and Dr. Lakshmi Prasad Dasi, who provides testimony in support of Patent
`Owner. We also provide a table identifying the primary references relied
`upon by Petitioner, as well as the exhibits corresponding to the declarations
`and deposition testimony in the record for Dr. Goldberg and Dr. Dasi.
`Dr. Goldberg indicates he received a Bachelor of Arts in Mathematics
`in 1980 and an M.D. in 1984 from the University of Kansas. Ex. 1020 ¶ 7.
`He was a Fellow in Cardiology at the University of California, Irvine from
`July 1990 through June 1993; an Assistant Professor of Medicine at UCLA
`from October 1993 through June 2000; and at the University of Washington
`Medical Center he was a practicing Interventional Cardiologist, an Associate
`Professor of Medicine from 2000 to 2006, a Clinical Associate Professor of
`Medicine from 2006 to 2014, and the director of the University of
`Washington Medical Center’s Catheterization Laboratory from 2004
`through 2014. Id. ¶¶ 10, 13, 14. Dr. Goldberg states he is the Medical
`Director for Structural Heart Disease at the Tyler Heart Institute,
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`IPR2020-01649
`Patent 9,125,739 B2
`Community Hospital of the Monterey Peninsula, and the Chief Medical
`Officer of a “medical device company that develops novel tools for the
`treatment of heart failure and related conditions.” Id. ¶¶ 4, 5. Dr. Goldberg
`also states that he has “implanted over 10,000 stents and performed
`hundreds of valvuloplasties of all heart valves,” “was a clinical study proctor
`for some of the first-ever-FDA approved stents,” and has “implanted
`about 70 transcatheter heart valves in patients.” Id. ¶¶ 18, 22.
`Patent Owner argues that “Dr. Goldberg fell into the trap of opining as
`one of extraordinary skill in the art,” because at his deposition “he testified
`that in forming his opinions, he applied all of his experience up until
`January 4, 2002.” Resp. 3 (citing Ex. 2020, 20:5–14). According to Patent
`Owner the “agreed upon definition of a person of ordinary skill required
`“two years of experience,” and in 2002 Dr. Goldberg had “been practicing in
`the relevant field for approximately 17 years.” Id. We find Patent Owner’s
`argument unpersuasive, because it misrepresents Dr. Goldberg’s testimony,
`as follows:
`
`Q. Did you apply all of the qualifications and
`experience that you set forth in your declaration up until
`January 4th, 2002, in reaching the opinions you set forth in your
`declaration, other than the Paniagua opinions?
`A. The phrasing of the question is slightly confusing, but
`I believe that what you're asking is, did I consider the
`perspective of somebody whose knowledge -- a person skilled
`in the art’s knowledge was January 4th, 2002, and before. And
`hopefully, I answered your question correctly, but if not, it was
`due to my misunderstanding.
`Q. (By Ms. Spires) No problem. I do appreciate the
`clarification. So I think part of the awkward wording is
`because of these two sections. So I’ll say, right now, I'm going
`to be putting aside the Paniagua grounds that you used the 2014
`date for. So for all other grounds, did you apply all of your
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`IPR2020-01649
`Patent 9,125,739 B2
`own qualifications and experience up until January 4th, 2002, in
`reaching the opinions you put -- set forth in your declaration?
`A.
`If I understand you correctly, yes. Yes. You don't
`phrase it in a way that is intuitively clear to a layperson, and --
`but that’s why I'm hedging just a little bit. But I believe we're
`on the same page and that I did apply that date as the date that
`I’m using as the reference.
`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 --
`Q. (By Ms. Spires) -- reaching your opinions.
`A. Yes.
`Ex. 2020, 18:20–20:14 (objections to form omitted). We find no clear
`inconsistency between Dr. Goldberg’s testimony and his declaration, which
`expressly states as follows:
`I am informed that the scope and content of the prior art
`must be determined, as well as the level of ordinary skill in the
`art. I am further informed that a patent claim was obvious at the
`time of the invention if the differences between the subject matter
`sought to be patented and the prior art are such that the subject
`matter as a whole would have been obvious to a person having
`ordinary skill in the art. I am further informed that the focus when
`making a determination of obviousness should be on what a
`hypothetical person of ordinary skill in the pertinent art would
`have known at the time of the invention, and on what such a
`person would have reasonably expected to have been able to do
`in view of that knowledge.
`Ex. 1020 ¶ 90. Dr. Goldberg did not state in his deposition or elsewhere that
`he was applying his personal perspective in place of what a person of
`ordinary skill in the art would have known at the time of the invention, or
`that a person of ordinary skill in the art at the time of the invention would
`have known everything he knew in 2002. To the contrary, Dr. Goldberg
`expressly explained that his opinion was based on what “a person of
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`Patent 9,125,739 B2
`ordinary skill in the art” would have recognized, and further articulated what
`the qualifications he considered a person of ordinary skill in the art would
`have had at the relevant time. See, e.g., id., ¶¶ 26, 27, 41, 42, 47. Patent
`Owner disregards numerous other instances during the deposition when
`Dr. Goldberg was asked and addressed his opinion in the context of what
`would have been known to a person of ordinary skill in the art at the time of
`the invention, not “his own perspective” at the time of the invention. See,
`e.g., Ex. 2020, 24:5–10, 34:14–35:7, 36:5–37:6. Lastly, Patent Owner
`identifies an agreed-upon level of ordinary skill in the art, which we adopt
`below, and which includes a minimum level of education and experience,
`but not a maximum level. See infra Section II.B. Thus, Patent Owner fails
`to articulate a factual basis to support its argument that Dr. Goldberg’s
`qualifications in 2002 were outside of the level of ordinary skill in the art.
`See Kyocera Senco Indus. Tools Inc. v. Int'l Trade Comm’n, 22 F.4th 1369
`(Fed. Cir. 2022) (“To offer expert testimony from the perspective of a
`skilled artisan in a patent case . . . a witness must at least have ordinary skill
`in the art.”) (emphasis added).
`Both parties discuss Neutrino Development Corp. v. Sonosite, Inc.,
`410 F. Supp. 2d 529 (S.D. Tex. 2006). Resp. 3–4; Reply 25–26.
`In Neutrino, the district court rejected an attempt to exclude expert
`testimony, noting that the witness “never asserts that he applied his own
`perspective” to his unpatentability analysis and recognized that the expert’s
`“opinions as to the level of ordinary skill in the art are necessarily based on
`his own experience.” 410 F. Supp. at 550. We find the same reasoning
`applies to Dr. Goldberg’s testimony in this case. As Dr. Goldberg’s
`qualifications are otherwise undisputed, we also determine that Dr. Goldberg
`is qualified to opine on the issues in this proceeding from the perspective of
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`IPR2020-01649
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`a person of ordinary skill in the art. Ex. 1020, 102–146 (Dr. Goldberg’s
`curriculum vitae).
`Dr. Dasi indicates he received a Bachelor’s of Technology in Civil
`Engineering in 1998 from the Indian Institute of Technology, received a
`Master’s of Science in Civil and Environmental Engineering in 2000 from
`the Georgia Institute of Technology, completed a Ph.D. in Civil and
`Environmental Engineering in 2004, and was a Postdoctoral Fellow in the
`Department of Biomedical Engineering at the Georgia Institute of
`Technology in 2004 to 2005. Ex. 2027, 4–5. We note that at the time of the
`invention of the ’739 patent, which claims priority back to 2002, Dr. Dasi
`was not yet working in the field of heart valve replacement. Ex. 1001,
`code (63), 1:20–21; see also infra Section II.B (discussing the qualifications
`of a person of ordinary skill).
`Dr. Dasi states he is a professor in the Department of Biomedical
`Engineering at the Georgia Institute of Technology, a Fellow of the
`American College of Cardiology, a Fellow of the American Institute
`of Medical and Biological Engineering, has directed a research program in
`heart valve engineering, and is a named inventor on three U.S. patents in
`the field of cardiovascular devices, with additional applications pending.
`Ex. 2019 ¶¶ 7–17. As his current qualifications in the pertinent art are
`undisputed, we determine that Dr. Dasi is qualified to opine on the issues in
`this proceeding from the perspective of a person of ordinary skill in the art.
`Ex. 2027 (Dr. Dasi’s curriculum vitae).
`
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`Patent 9,125,739 B2
`
`Ex. No.
`Date
`1006
`Jan. 5, 1999
`1007
`July 26, 1994
`Sept. 28, 1999 1012
`May 26, 2005 1015
`
`References and Witness Testimony3
`U.S. Patent No. 5,855,601 (“Bessler”)
`U.S. Patent No. 5,332,402 (“Teitelbaum”)
`U.S. Patent No. 5,957,949 (“Leonhardt”)
`U.S. Patent App. No. 2005/0113910 A1
`(“Paniagua”)
`U.S. Patent App. No. 2001/0044633 A1
`(“Klint”)
`U.S. Patent App. No. 2002/0032481 A1
`(“Gabbay”)
`Sept. 18, 2020 1020
`Declaration of Steven L. Goldberg, M.D.
`Sept. 10, 2021 1036
`Reply Declaration of Steven L. Goldberg, M.D.
`Deposition Transcript of Dr. Steven L. Goldberg May 28, 2021 2020
`Declaration of Dr. Lakshmi Prasad Dasi
`June 11, 2021 2019
`Deposition Transcript of Dr. Lakshmi Prasad
`Aug. 25, 2021 1039
`Dasi
`
`Nov. 22, 2001 1019
`
`Mar. 14, 2002 1009
`
`F. Asserted Grounds of Unpatentability
`Petitioner asserts that the Challenged Claims are unpatentable based
`on the following grounds (Pet. 26):
`Claim(s) Challenged
`35 U.S.C. §
`1–5
`103(a)
`1–5
`103(a)
`1–5
`103(a)
`1–5
`103(a)
`1–5
`102(b)
`
`3 The table identifies only a select number of documents particularly
`pertinent to this Decision. See, e.g., Paper 23 (Patent Owner’s List of
`Exhibits); Paper 24 (Petitioner’s Updated Exhibit List). A complete
`identification of the papers and exhibits that form the record of this case is
`available in the docket of this proceeding.
`
`Reference(s)/Basis
`Bessler, Teitelbaum
`Bessler, Leonhardt
`Bessler, Leonhardt, Klint
`Bessler, Teitelbaum, Klint
`Paniagua
`
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`
`II. ANALYSIS
`A. Legal Standards of Anticipation and Obviousness
`Petitioner contends under one ground that the Challenged Claims are
`anticipated. Pet. 26. A claim is anticipated if a single prior art reference
`either expressly or inherently discloses every limitation of the claim.
`Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967, 975 (Fed. Cir. 2010).
`“A single prior art reference may anticipate without disclosing a feature of
`the claimed invention if such feature is necessarily present, or inherent, in
`that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed.
`Cir. 2014) (citing Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1377
`(Fed. Cir. 2003)).
`Petitioner contends under four grounds that the Challenged Claims are
`unpatentable based on obviousness.4 Pet. 26. As set forth in 35 U.S.C.
`§ 103(a),
`[a] patent may not be obtained . . . if the differences between the
`subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in
`the art to which said subject matter pertains.
`The question of obviousness is resolved on the basis of underlying factual
`determinations including (1) the scope and content of the prior art; (2) any
`differences between the claimed subject matter and the prior art; (3) the level
`of ordinary skill in the art; and (4) when in evidence, objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`
`4 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
`2013. Because the application from which the ’739 patent issued has an
`effective filing date prior to March 16, 2013, the pre-AIA version of § 103
`applies.
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`An obviousness analysis “need not seek out precise teachings directed
`to the specific subject matter of the challenged claim, for a court can take
`account of the inferences and creative steps that a person of ordinary skill in
`the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`(2007). However, Petitioner cannot satisfy its burden of proving
`obviousness by employing “mere conclusory statements.” In re Magnum
`Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead,
`Petitioner must articulate a reason why a person of ordinary skill in the art
`would have combined the prior art references. In re NuVasive, 842 F.3d
`1376, 1382 (Fed. Cir. 2016); see also Pers. Web Tech., LLC, v. Apple, Inc.,
`848 F.3d 987, 993–94 (Fed. Cir. 2017) (“[O]bviousness concerns whether a
`skilled artisan not only could have made but would have been motivated to
`make the combinations or modifications of prior art to arrive at the claimed
`invention”) (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073
`(Fed. Cir. 2015)).
`
`B. Person of Ordinary Skill in the Art
`The level of skill in the art is a factual determination that provides a
`primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v.
`VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950
`F.2d 714, 718 (Fed. Cir. 1991)). In determining the level of ordinary skill in
`the art, various factors may be considered, including the “type of problems
`encountered in the art; prior art solutions to those problems; rapidity with
`which innovations are made; sophistication of the technology; and
`educational level of active workers in the field.” In re GPAC Inc., 57 F.3d
`1573, 1579 (Fed. Cir. 1995) (citation omitted).
`
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`Petitioner contends that a person of ordinary skill in the art at the time
`of the invention “would have been an interventional cardiologist with a
`working knowledge of heart valve designs, expandable stents, and
`intravascular delivery systems for stents.”5 Pet. 41–42 (citing Ex. 1020
`¶ 27). Petitioner further states that such a person of ordinary skill “would,
`where necessary, work as a team in combination with a medical device
`engineer.” Id.
`Patent Owner proposes the same level of ordinary skill in the art that
`Petitioner agreed to in the -01454 IPR, which Patent Owner sets forth as
`follows:
`A [person of ordinary skill in the art] as 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.’
`Resp. 2 (quoting IPR2020-01454, Paper 1, 23); Ex. 2019 ¶¶ 21, 22.
`According to Patent Owner, Petitioner’s proposed definition does not allow
`for the “differentiation among those who possess ordinary skill in the art
`versus those who possess extraordinary skill in the art.” Resp. 2–3 (citing
`
`
`5 Petitioner provides the same level of ordinary skill for both its anticipation
`ground based on Paniagua as for the Bessler Grounds; however, Petitioner
`identifies April 15, 2014, as the date of invention for anticipation based on
`Paniagua and January 4, 2002, for the Bessler Grounds, noting that a person
`of ordinary skill as of the latter date “would have had the additional
`knowledge of the important developments in the art in the intervening 12
`years.” Pet. 41–42.
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`Envtl. Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 697 (Fed. Cir.
`1983)).
`Petitioner argues in its Reply that Patent Owner “identifies no issue
`that would be impacted by the choice of definition” of a person of ordinary
`skill. Reply 24. Petitioner also notes that Patent Owner’s proposed
`definition similarly “sets out the minimum requirements for a [person of
`ordinary skill in the art] with no upper limit on experience.” Id. at 25.
`We adopt Patent Owner’s definition as we find it is consistent with the
`level of skill in the art at the time of the invention, as reflected by the prior
`art and the ’739 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
`(Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill
`level are not required “where the prior art itself reflects an appropriate level
`and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v.
`Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). It is also
`identical to the definition Petitioner agreed to in the 01454-IPR, which
`applies in that proceeding as well. Our adoption of Patent Owner’s proposed
`definition does not reflect a view that adopting Petitioner’s competing
`definition of the level of ordinary skill in the art would have had any impact
`on the outcome of this proceeding. To the contrary, our conclusions would
`have been the same under either party’s definition.
`C. Claim Construction
`We apply 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). Under that standard, claim terms “are generally given their
`ordinary and customary meaning” as understood by a person of ordinary
`skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d
`1303, 1312–13 (Fed. Cir. 2005) (en banc). “In determining the meaning of
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`the disputed claim limitation, we look principally to the intrinsic evidence of
`record, examining the claim language itself, the written description, and the
`prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic
`Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips,
`415 F.3d at 1312–17). Extrinsic evidence is “less significant than the
`intrinsic record in determining ‘the legally operative meaning of claim
`language.’” Phillips, 415 F.3d at 1317. The parties specifically address
`three claim terms as follows. Pet. 37–41; Resp. 12–19.
` “flares at both ends in a trumpet-like configuration”
`Claim 1 recites “wherein the stent member includes a tubular structure
`away from a central portion that flares at both ends in a trumpet-like
`configuration.” Ex. 1001, 14:8–11. The Specification of the ’739 patent
`does not otherwise describe a “trumpet-like configuration” and provides no
`illustration of such a configuration. See id. at 7:62–63 (the only mention of
`“trumpet-like” in the Specification of the ’739 patent outside of claim 1
`states that “[a]way from its central portion, the tubular structure flares
`markedly at both ends in a trumpet-like configuration”).
`Patent Owner states that it has applied the construction adopted in
`related district court proceedings construing “‘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.’” Resp. 12 (citing
`Ex. 2025, 46; Ex. 2026; Ex. 2019 ¶¶ 66, 67). We discern no dispute over the
`meaning of “flares at both ends in a trumpet-like configuration” that requires
`an express construction. See Reply 23–30. See Wellman, Inc. v. Eastman
`Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only
`be construed ‘to the extent necessary to resolve the controversy.’”) (quoting
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`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed.
`Cir. 1999)).
` “a valve means”
`Claim 1 recites “a valve means.” Ex. 1001, 14:11. Petitioner argues
`that “valve means” is not a means-plus-function limitation because it
`“provides sufficient structure . . . when read in light of the [S]pecification.”
`Pet. 41 (citing Mass. Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1356
`(Fed. Cir. 2006)). Alternatively, if it is construed to be a means-plus-
`function limitation, Petitioner asserts “the [S]pecification provides adequate
`structure.” Id. (citing Ex. 1001, 5:1–5, 5:11–15, 6:55–57, 6:21–7:18, 8:26–
`9:25, 10:26–54, Figs. 1–3, 9). Patent Owner states that it has applied the
`construction adopted in related district court proceedings construing “‘valve’
`and ‘valve means’ to mean ‘portions of the replacement heart valve device
`that allow the one-way flow of blood.” Resp. 19 (citing Ex. 2025, 15;
`Ex. 2026; Ex. 2019 ¶¶ 78, 79). We discern no dispute over the meaning of
`“valve means” that requires an express construction. See Reply 23–30.
` “a delivery system . . . wherein the prosthetic heart valve is collapsed
`onto the pusher member”
`Claim 1 recites “a delivery system . . . wherein the prosthetic heart
`valve is collapsed onto the pusher member to reside in a collapsed
`configuration on the pusher member.” Ex. 1001, 14:17–24. Petitioner
`contends that “onto” means “in contact with,” such that claim 1 requires a
`prosthetic heart valve collapsed in contact with the pusher member. Pet. 37–
`41. Patent Owner disputes Petitioner’s proposed construction and does not
`propose an alternative express construction. Resp. 12–19.
`Petitioner reasons that the portion of the Specification of the ’739
`patent that discusses the “pusher member” “was copied nearly word-for-
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`word from Bessler,” and that “the ‘pusher member’ and the meaning of
`mounting the replacement heart valve device ‘onto’ the ‘pusher member’
`must be what Bessler teaches.” Pet. 37–38. Bessler is cited on the face of
`the ’739 patent. Ex. 1001, code (56). Petitioner does not suggest that the
`term “onto” appears anywhere in Bessler.
`To purportedly support its argument that Bessler must define terms in
`the ’739 patent, Petitioner turns to extrinsic evidence from a district court
`proceeding in which Patent Owner allegedly made arguments concerning a
`different patent from the ’739 patent with the same specification to show
`that Patent Owner “argued that the only embodiment of a delivery system in
`the ’739 Patent that describes using a pusher member to push out a
`prosthetic device is the one that was copied from Bessler.” Pet. 38.
`Petitioner then turns to a figure from Bessler, which does not appear in the
`’739 patent, to allegedly show that Bessler teaches a replacement heart valve
`“in contact with” a pusher member. Id. at 38–39 (citing Ex. 1006, Fig. 14).
`Petitioner’s reasoning then turns to the prosecution h