Trials@uspto.gov
`571-272-7822
`
`Paper 27
`Entered: March 24, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MEDTRONIC COREVALVE LLC,
`EDWARDS LIFESCIENCES CORPORATION, AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`v.
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`
`IPR2020-014541
`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)
`
`
`
`
`1 Edwards Lifesciences Corporation and Edwards Lifesciences LLC filed a
`petition in IPR2021-00775 and are joined as petitioner in this proceeding.
`
`
`
`

`

`IPR2020-01454
`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 Medtronic CoreValve LLC, Edwards
`Lifesciences Corporation, and Edwards Lifesciences LLC (“Petitioner”)2 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
`Medtronic CoreValve LLC filed a Petition on September 2, 2020,
`pursuant to 35 U.S.C. §§ 311–319, requesting an inter partes review of the
`Challenged Claims. Paper 2 (“Pet.”). On March 10, 2021, we instituted an
`inter partes review of the Challenged Claims on all grounds of
`unpatentability asserted in the Petition. Paper 11. Within one month of
`institution of review, on April 6, 2021, Edwards Lifesciences Corporation
`and Edwards Lifesciences LLC filed a petition in IPR2021-00775
`substantively identical to the Petition in this proceeding, along with a motion
`for joinder to this proceeding. IPR2021-00775, Papers 2 and 3. We
`instituted trial in IPR2021-00775 and granted the motion joining Edwards
`Lifesciences Corporation and Edwards Lifesciences LLC as petitioner to this
`proceeding. Paper 17.
`
`
`2 Medtronic CoreValve LLC identifies Medtronic Inc. as an additional real
`party in interest. Pet. 7. Edwards Lifesciences Corporation and Edwards
`Lifesciences LLC identify no additional real parties in interest. IPR2021-
`00775, Paper 2, 7.
`
`2
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`IPR2020-01454
`Patent 9,125,739 B2
`Colibri Heart Valve LLC (“Patent Owner”)3 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 (“Tr.”). 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).
`B. Related Matters
`The ’739 patent is also challenged in Edwards Lifesciences Corp. and
`Edwards Lifesciences LLC v. Colibri Heart Valve LLC, IPR2020-01649
`(filed September 18, 2020), 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”). Pet. 7;
`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-
`001453, Paper 11 (PTAB Mar. 5, 2021).
`
`
`3 Patent Owner identifies no additional real parties in interest. Paper 4, 1.
`
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`IPR2020-01454
`Patent 9,125,739 B2
`
`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, 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.
`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.
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`IPR2020-01454
`Patent 9,125,739 B2
`
`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
`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.
`
`
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`IPR2020-01454
`Patent 9,125,739 B2
`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
`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
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`IPR2020-01454
`Patent 9,125,739 B2
`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
`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
`Dr. William J. Drasler, 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. Drasler and Dr. Dasi.
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`Patent 9,125,739 B2
`Dr. Drasler indicates he received a Ph.D. in Biomedical Engineering
`in 1983, was employed by various medical device companies between 1983
`and 2008 where he worked on interventional cardiology devices, founded
`and served as Chief Technology Officer from 2008 to 2015 for a company
`that developed a product for Transcatheter Aortic Valve Replacement
`procedures, and currently works as a consultant for a medical device
`company on a product for such procedures. Ex. 1002 ¶¶ 11–18.
`Patent Owner argues that Dr. Drasler applied “an incorrect standard to
`his obviousness analysis,” because “he required a combination to produce
`unexpected results in order to be non-obvious.” Resp. 8 (citing Ex. 2020,
`19:13–20:16, 24:5–17). We find Patent Owner’s argument unpersuasive
`because, in addition to Dr. Drasler not having been offered as an expert in
`patent law, Patent Owner’s description of Dr. Drasler’s testimony is a
`misrepresentation of what was said during the deposition, as follows:
`Q.
`Sure. Do you have an understanding as
`to whether an unexpected result is required for
`the combination of two references to not be obvious?
`A. Yeah I -- I believe that that type of
`question is -- goes beyond what I was asked to do
`here as an expert, and as a result, I think it --
`it perhaps is -- is beyond -- beyond where I
`should make my comment. I think that there’s
`probably other -- other reasons that I can’t go
`into because I’m not a patent attorney that would
`make something obvious other than the unexpected
`result.
`Ex. 2020, 21:1–14 (objection omitted). The other portions of Dr. Drasler’s
`testimony cited by Patent Owner are not to the contrary. See id. at 19:13–20
`(in response to questions about “hindsight” Dr. Drasler stated “let’s say there
`was two things that were out there, and you're going to combine them in a --
`
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`IPR2020-01454
`Patent 9,125,739 B2
`a nonobvious way, in a way that is not -- gives an unexpected result, then I
`think it would not be obvious”), 24:5–17 (Dr. Drasler confirmed his opinion
`that “[i]f components are brought together in a manner that does not provide
`any unexpected result and would be obvious to someone skilled in the art at
`the time, then it would not be a patentable device” (emphasis added)); see
`also Reply 28 (discussing examples from Dr. Drasler’s testimony to show
`that he understood “that unexpected results were not the only way something
`could be nonobvious”).
`Next, Patent Owner argues that Dr. Drasler’s testimony “should be
`entitled to little, if any, weight,” because he purportedly “admitted to
`opining based on his own perspective, rather than from the perspective of a
`[person of ordinary skill in the art].” Resp. 8–9 (citing Ex. 2020, 22:18–
`23:4). The testimony cited by Patent Owner is as follows:
`Q.
`Fair. I’ll clarify the question.
`So in reaching the opinions you set forth in your
`declaration, did you apply all of the experience that you
`set forth in your CV up to the January 4th, 2002, date?
`A.
`I have a -- I believe the answer is yes.
`I -- I would use anything and everything I knew up to
`that point in 2002.
`Ex. 2020, 22:18–23:4 (objection omitted). We find no clear inconsistency
`between Dr. Drasler’s testimony and his declaration, which expressly states
`as follows:
`I understand that obviousness is determined from the perspective
`of a hypothetical person of ordinary skill in the art and that the
`asserted claims of the patent should be read from the point of
`view of such a person at the time the claimed invention was
`made.
`Ex. 1002 ¶ 24. Dr. Drasler did not state in his deposition or elsewhere that
`he was applying his personal perspective in place of what a person of
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`IPR2020-01454
`Patent 9,125,739 B2
`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 “anything and everything” he knew in 2002. To the contrary,
`Dr. Drasler expressly explained that “[i]n rendering the opinions set forth in
`this declaration, I was asked to consider the patent claims and the prior art
`through the eyes of a person of ordinary skill in the art at the time of the
`alleged invention,” and further articulated what the qualifications he
`considered a person of ordinary skill in the art would have had at the
`relevant time. Id. at ¶¶ 30, 31. Further, as Petitioner shows, Patent Owner
`disregards numerous other instances during the deposition when Dr. Drasler
`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. Reply 28 (citing Ex. 2020, 23:10–
`24:17, 58:13–59:10). Lastly, Patent Owner does not dispute Petitioner’s
`proposed 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. Drasler’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. 9; Reply 28. 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
`
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`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. Drasler’s testimony in this case. As Dr. Drasler’s qualifications are
`otherwise undisputed, we also determine that Dr. Drasler is qualified to
`opine on the issues in this proceeding from the perspective of a person of
`ordinary skill in the art. Ex. 1002, App’x B (Dr. Drasler’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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`IPR2020-01454
`Patent 9,125,739 B2
`
`References and Witness Testimony4
`U.S. Patent No. 6,425,916 B1 (“Garrison”)
`U.S. Patent No. 5,957,949 (“Leonhardt”)
`U.S. Patent No. 5,961,549 (“Nguyen”)
`U.S. Patent No. 5,840,081 (“Andersen”)
`U.S. Patent No. 6,077,295 (“Limon”)
`U.S. Patent No. 7,025,780 B2 (“Gabbay”)
`WO 00/15147 (“Phelps”)
`Declaration of William J. Drasler, Ph.D. in
`Support of Petition for Inter Partes Review of
`U.S. Patent No. 9,125,739
`Declaration of William J. Drasler in Support of
`Petitioner’s Reply to Patent Owner Response
`Deposition Transcript of William J. Drasler,
`Ph.D.
`Declaration of Dr. Lakshmi Prasad Dasi
`
`Ex. No.
`Date
`1005
`July 30, 2002
`Sept. 28, 1999 1006
`Oct. 5, 1999
`1020
`Nov. 24, 1998 1013
`June 20, 2000 1008
`Apr. 11, 2006 1009
`Mar. 23, 2000 1010
`Sept. 1, 2020
`1002
`
`Aug. 25, 2021 1041
`
`May 19, 2021 2020
`
`June 2, 2021
`
`2019
`
`Reference(s)/Basis
`
`F. Asserted Grounds of Unpatentability
`Petitioner asserts that the Challenged Claims are unpatentable based
`on the following grounds:
`Claim(s)
`Challenged 35 U.S.C. §
`1–5
`103(a)
`1–5
`103(a)
`1–5
`103(a)
`1–5
`103(a)
`
`4 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.
`
`Garrison
`Garrison, Leonhardt
`Garrison, Nguyen
`Garrison, Leonhardt, Nguyen
`
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`
`Reference(s)/Basis
`
`Claim(s)
`Challenged 35 U.S.C. §
`Andersen, Limon, Gabbay
`1–3, 5
`103(a)
`Andersen, Limon, Phelps
`1–3, 5
`103(a)
`Andersen, Limon, Phelps, Nguyen
`1–3, 5
`103(a)
`Andersen, Limon, Gabbay, Garrison
`4
`103(a)
`Andersen, Limon, Phelps, Garrison
`4
`103(a)
`Andersen, Limon, Phelps, Nguyen, Garrison
`4
`103(a)
`Pet. 10–11. We refer to the grounds based on Garrison, alone or in
`combination with Leonhardt and/or Nguyen (i.e., the first four grounds in
`the table above) as the “Garrison Grounds,” and the six grounds including
`Andersen and Limon as the “Andersen/Limon Grounds.”
`II. ANALYSIS
`A. Legal Standards of Obviousness
`Petitioner contends under ten grounds that the Challenged Claims are
`unpatentable based on obviousness.5 Pet. 10–11. 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
`
`
`5 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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`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).
`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
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`educational level of active workers in the field.” In re GPAC Inc., 57 F.3d
`1573, 1579 (Fed. Cir. 1995) (citation omitted).
`Petitioner asserts that a person of ordinary skill in the art at the time of
`the invention 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.
`Pet. 23 (citing Ex. 1002 ¶¶ 30–33). Patent Owner does not dispute
`Petitioner’s definition of a person of ordinary skill in the art. Resp. 2.
`We adopt Petitioner’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))).
`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
`the disputed claim limitation, we look principally to the intrinsic evidence of
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`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. Petitioner asserts that all claim
`terms in the Challenged Claims should receive their plain and ordinary
`meanings. Pet. 23. Petitioner discusses three claim terms as follows. Id.
`at 24–25.
` “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”).
`For the term “trumpet-like,” Petitioner asserts only that the prior art
`discloses the limitation regardless of its exact metes and bounds. Pet. 24
`(citing Ex. 1002 ¶¶ 61–63). 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. 7 (citing Ex. 2025, 46; Ex. 2026; Ex. 2019 ¶¶ 72, 73). We discern no
`dispute over the meaning of “trumpet-like” that requires an express
`construction. See Reply 1. See Wellman, Inc. v. Eastman Chem. Co., 642
`
`16
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`

`IPR2020-01454
`Patent 9,125,739 B2
`F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to
`the extent necessary to resolve the controversy.’”) (quoting 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 the
`remainder of the limitation “does not recite a function.” Pet. 24.
`Alternatively, if it is construed to be a means-plus-function limitation,
`Petitioner asserts “the function/structure would be the function and structure
`of a valve.” Id. (citing Ex. 1001, 3:18–4:32). 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. 7–8 (citing
`Ex. 2025, 15; Ex. 2026; Ex. 2019 ¶¶ 74, 75). We discern no dispute over the
`meaning of “valve means” that requires an express construction. See
`Reply 1.
` “controlled release mechanism”
`Claim 5, which depends from claim 1, recites “wherein the pusher
`member includes a controlled release mechanism that can be activated.”
`Ex. 1001, 14:37–38. Petitioner argues “controlled release mechanism” is not
`a means-plus-function limitation, because it does not recite “means for.”
`Pet. 25. Alternatively, if it is construed to be a means-plus-function
`limitation, Petitioner asserts as follows:
`[T]he function would be: controlling release of device during
`deployment; and the corresponding structure would be: a pusher
`member that can be activated by pushing out the pusher member
`and the prosthetic heart valve partially from the sheath such that
`
`17
`
`

`

`IPR2020-01454
`Patent 9,125,739 B2
`the stent member partially expands, but is restrained so it doesn’t
`pop out.
`Id. (citing Ex. 1001, 11:51–59, 12:24–28).
`Patent Owner states that it has applied the definition of “controlled
`release” purportedly provided by Dr. Drasler as “that ‘the operator can
`control when the valve . . . is released,’ including ‘control [of the valve’s
`release] so that [the valve] doesn’t just arbitrarily pop out . . . when [the
`operator] do[es]n’t want it to.’” Resp. 8 (quoting Ex. 2020, 87:7–18)
`(alterations in original). The complete exchange Patent Owner cites is as
`follows:
`
`Q. And so I think, in paragraph 69 of your
`declaration -- let me turn there really quickly. In that
`paragraph, you're talking about – that paragraph and
`the one above it, you’re talking about the meaning of
`controlled release mechanism?
`A. Yes.
`Q. And so I think you -- you sort of set forth a
`meaning of that in paragraph 69, and so I wanted to see
`if I understand what you’re saying. Is it the case that,
`to one of ordinary skill in the art, you would view
`controlled release meaning that the operator can
`control when the valve of Garrison is released from the
`sheath?
`A. Control when it's released, and control it so
`that it doesn’t just arbitrarily pop out, so it has some
`frictional aspect to it so that it doesn’t want to just go
`outwards and -- when you don’t want it to, yes.
`Ex. 2020, 87:1–18. Thus, Dr. Drasler’s full testimony makes clear that in
`his opinion a frictional force is sufficient to act as the mechanism for
`controlled release of the valve. Further, Paragraph 69 of Dr. Drasler’s
`Declaration, referenced in the deposition exchange above, provides the same
`definition of “controlled release” provided in the Petition, as discussed
`
`18
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`

`

`IPR2020-01454
`Patent 9,125,739 B2
`above, not what Patent Owner purports to be the definition “provided by
`Dr. Drasler” taken from a shortened excerpt from his deposition. Ex. 1002
`¶ 69. We therefore reject Patent Owner’s argument that Dr. Drasler’s
`deposition testimony provided a definition of “controlled release
`mechanism” different from what is provided in the Petition, because Patent
`Owner’s argument misrepresents Dr. Drasler’s testimony.
`Petitioner further argues in reply that “as Dr. Drasler testified, there
`must be some mechanism to control the valve’s release—which is simply the
`term’s plain and ordinary meaning.” Reply 2 (citing Ex. 1041 ¶¶ 13, 14).
`According to Petitioner, an express construction is unnecessary because
`“under the plain and ordinary meaning, any reasonable construction and
`[Patent Owner’s] construction,” the limitation is taught by the asserted art.
`Id. Thus, we discern no dispute over the meaning of “controlled release
`mechanism” that requires an express construction.
` Additional Claim Terms
`We find that no other claim term requires an express construction for
`purposes of rendering this Decision. See Wellman, 642 F.3d at 1361.
`D. Scope and Content of the Asserted Art Under the Garrison Grounds
`Under the Garrison grounds, Petitioner also relies on Leonhardt and
`Nguyen. Pet. 27–52. Each of these references is summarized in relev