Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 1 of 59 Page ID
`#:1905
`
`
`DAVID KEYZER (SB# 248585)
`david@keyzerlaw.com
`LAW OFFICE OF DAVID KEYZER, P.C.
`5170 Golden Foothill Parkway
`El Dorado Hills, CA 95762
`Telephone: (916) 243-5259
`Facsimile: (916) 404-0436
`
`
`
`
`
`
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`SOUTHERN DIVISION
`
` Case No. 8:20-CV-00847-DOC-JDE
`
` Hon. David O. Carter
`
`
` TECHNICAL SPECIAL MASTER
`
` REPORT AND RECOMMENDATION
`
` ON CLAIM CONSTRUCTION
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`
`
`v.
`
`
`
`COLIBRI HEART VALVE LLC,
`
`
`
`
`
`MEDTRONIC COREVALVE LLC,
`
`
`
`Plaintiff,
`
`Defendant.
`
`16
`
`
`
`17
`
`
`
`The undersigned, having been appointed Technical Special Master pursuant to
`
`Rule 53 of the Federal Rules of Civil Procedure to conduct claim construction
`
`proceedings in the above-captioned case, submits this Report and Recommendation on
`
`Claim Construction.
`
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 1
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 1 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 2 of 59 Page ID
`#:1906
`
`
`Table of Contents
`
`I. INTRODUCTION ................................................................................................... 2
`II. THE PATENTS-IN-SUIT ..................................................................................... 3
`III. LEGAL STANDARDS ........................................................................................ 4
`IV. THE DISPUTED TERMS ................................................................................... 5
`A. “valve” and “valve means” ............................................................................ 5
`B. “residing entirely within an inner channel of the stent member” and
`“resides entirely within the inner channel of the stent member” ...................... 16
`C. “flares at both ends in a trumpet-like configuration” .................................. 37
`D. “pushing out the pusher member from the moveable sheath” .................... 46
`V. CONCLUSION .................................................................................................... 59
`
`
`
`
`
`
`
`I. INTRODUCTION
`
`Plaintiff Colibri Heart Valve LLC (“Plaintiff” or “Colibri”) asserts United States
`
`Patents No. 8,900,294 (“the ’294 Patent”) and 9,125,739 (“the ’739 Patent”)
`
`(collectively, “the patents-in-suit”) against Defendant Medtronic CoreValve LLC
`
`(“Defendant” or “Medtronic”). Plaintiff asserts Claims 1–4 of the ’294 Patent and
`
`Claims 1–3 and 5 of the ’739 Patent. (Dkt. 84 at 2–3.) “The accused products are
`
`Medtronic’s transcatheter aortic valve replacement products: CoreValve, CoreValve
`
`Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+.” (Id. at 9.)
`
`
`
`The parties submitted their respective Opening Claim Construction Briefs on
`
`December 18, 2020 (Dkt. 84, “Pl. CC Opening”; Dkt. 83, “Def. CC Opening”). The
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 2
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 2 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 3 of 59 Page ID
`#:1907
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`parties submitted their respective Responsive Claim Construction Briefs on January 11,
`
`2021 (Dkt. 86, “Pl. CC Response”; Dkt. 85, “Def. CC Response”). Also before the
`
`Technical Special Master are the parties’ December 9, 2020 Joint Claim Construction
`
`Chart (Dkt. 79, Ex. A) (“JCCC”), Plaintiff’s Opening Supplemental Claim Construction
`
`Brief (Dkt. 91) (“Pl. Suppl. Opening”), Defendant’s Supplemental Responsive Markman
`
`Brief (Dkt. 93) (“Def. Suppl. Response”), and Plaintiff’s Supplemental Claim
`
`Construction Reply Brief (Dkt. 95) (“Pl. Suppl. Reply”).
`
`
`
`Pursuant to the Court’s November 24, 2020 Order Appointing Technical Special
`
`Master (Dkt. 75), the Technical Special Master entered orders regarding the
`
`10
`
`proceedings1 and conducted a claim construction hearing on February 1, 2021.
`
`11
`
`
`
`Based on the above-cited briefing as well as the oral arguments presented by
`
`12
`
`counsel at the February 1, 2021 hearing, the Technical Special Master construes the
`
`13
`
`disputed terms as set forth herein.
`
`14
`
`II. THE PATENTS-IN-SUIT
`
`15
`
`
`
`The ’294 Patent, titled “Method of Controlled Release of a Percutaneous
`
`Replacement Heart Valve,” issued on December 2, 2014. The ’739 Patent, titled
`
`“Percutaneous Replacement Heart Valve and a Delivery and Implantation System,”
`
`
`1 (Dkt. 81-1, Dec. 11, 2020 Technical Special Master Order No. TSM-1 (setting
`5:00 P.M. deadlines for claim construction briefing); Dkt. 82-1, Dec. 11, 2020 Technical
`Special Master Order No. TSM-2 (setting claim construction hearing and regarding
`conduct of claim construction hearing); Dkt. 87-1, Jan. 21, 2021 Technical Special
`Master Order No. TSM-3 (superseding Order. No. TSM-2).)
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 3
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 3 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 4 of 59 Page ID
`#:1908
`
`
`issued on September 8, 2015. Both of the patents-in-suit bear an earliest priority date of
`
`January 4, 2002.
`
`
`
`Plaintiff submits: “The patents-in-suit claim inventions that include an artificial
`
`heart valve device and a system for delivering the device to a patient’s heart. Delivery of
`
`the device is achieved by making a small incision in the patient’s skin and then guiding
`
`the device (collapsed inside a thin, flexible tube) through a blood vessel, to the patient’s
`
`heart, where the device is positioned and implanted. The patented technology is far less
`
`invasive than open heart surgery.” (Pl. CC Opening at 1.) The Abstract of the ’294
`
`Patent, for example, states:
`
`A method of making a replacement heart valve device whereby a fragment
`of biocompatible tissue material is treated and soaked in one or more
`alcohol solutions and a solution of glutaraldehyde. The dried biocompatible
`tissue material is folded and rehydrated in such a way that forms a two- or
`three-leaflet/cusp valve without affixing of separate cusps or leaflets or
`cutting slits into the biocompatible tissue material to form the cusps or
`leaflets. After the biocompatible tissue material is folded, it is affixed at
`one or more points on the outer surface to the inner cavity or a stent.
`
`Plaintiff submits that “[t]he ’294 Patent and the ’739 Patent share a common
`
`
`
`specification.” (Id.)
`
`III. LEGAL STANDARDS
`
`
`
`The Court has set forth relevant legal principles in, for example, Spigen Korea Co.
`
`Ltd. v. Lijun Liu, et al., No. 2:16-CV-09185-DOC-DFM, Dkt. 215, 2018 WL 8130608,
`
`slip op. at 10–11 (C.D. Cal. Dec. 12, 2018), and Limestone Memory Systems, LLC v.
`
`Micron Technology, Inc., No. 8:15-CV-00278-DOC-KES, Dkt. 242, 2019 WL 6655273,
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 4
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 4 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 5 of 59 Page ID
`#:1909
`
`
`slip op. at 2–8 (C.D. Cal. Sept. 11, 2019). For example, the Court noted that “[i]t is a
`
`bedrock principle of patent law that the claims of a patent define the invention to which
`
`the patentee is entitled the right to exclude.” Spigen Korea, No. 2:16-CV-09185-DOC-
`
`DFM, Dkt. 215, slip op. at 10 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1312
`
`(Fed. Cir. 2005) (en banc)). The Court also noted that “the terms must be read in the
`
`context of the entire patent.” Id. (citing Phillips, 415 F.3d at 1314).
`
`IV. THE DISPUTED TERMS
`
`A. “valve” and “valve means”
`
`Plaintiff’s Proposed Construction
`
`Defendant’s Proposed Construction
`
`the portions of the replacement heart
`valve device that attach to the stent and
`allow the one-way flow of blood
`
`a structure comprised of a tubular
`portion and leaflets that open and
`close to allow the one-way flow of
`blood2
`
`Supplemental Proposal:
`the portions of pericardial tissue,
`including leaflets that open and close,
`that allow the one-way flow of blood
`
`
`
`(JCCC at 1; Pl. CC Opening at 6; Def. CC Opening at 1; Pl. CC Response at 1; Def. CC
`
`Response at 1; Pl. Suppl. Opening at 1.) The parties submit that these terms appear in
`
`
`2 In its responsive claim construction brief, Plaintiff alternatively proposes: “To the
`extent that the Court agrees with Medtronic’s interpretation of th[e] embodiment
`[disclosed at column 9, lines 8–25 of the specification of the patents-in-suit, which is
`discussed in this Report and Recommendation, below], Colibri proposes the construction
`that valve/valve means is understood to mean ‘a structure comprised of leaflets that open
`and close to allow the one-way flow of blood.’” (Pl. CC Response at 5 n.3.)
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 5 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 6 of 59 Page ID
`#:1910
`
`
`Claim 1 of the ’294 Patent and Claim 1 of the ’739 Patent. (JCCC at 1.)
`
`
`
`The parties agree that “valve” and “valve means” “should have a single, common
`
`construction governing those terms” in the claim limitations that are at issue in the
`
`present case. (Pl. CC Opening at 3; see Def. CC Response at 2 n.1.) At the February 1,
`
`2021 hearing, the parties confirmed (at least for purposes of these claim construction
`
`proceedings) that the terms “valve” and “valve means” are used interchangeably in the
`
`patents-in-suit.
`
`
`
`
`
`(1) The Parties’ Positions
`
`Plaintiff argues that “the specification consistently describes the ‘valve means’ as
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`having the two components (tubular portion and leaflets) Colibri identifies in its
`
`11
`
`proposed construction.” (Pl. CC Opening at 6.) Plaintiff also argues that “the
`
`12
`
`specification makes clear that the ‘cusps’ or ‘leaflets’ are what allow the one-way flow
`
`13
`
`of blood.” (Id. at 7.) Plaintiff urges that Defendant’s proposed construction is confusing
`
`14
`
`and inaccurate as to “portions” because “[t]here is no disagreement that the valve means
`
`15
`
`is attached to the stent, but that does not mean each portion of the valve means is
`
`16
`
`attached to the stent.” (Id.) Plaintiff submits that “the specification makes clear the
`
`17
`
`valve means may be attached to the stent by only some of its parts.” (Id. at 8.) “Most
`
`18
`
`importantly,” Plaintiff argues, “the specification provides that, depending on the
`
`19
`
`embodiment, the cusps or leaflets (i.e., the portion of the valve means that allows the
`
`20
`
`one-way flow of blood, as noted above) may or may not be directly attached to the stent,
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 6
`
`
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 6 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 7 of 59 Page ID
`#:1911
`
`
`as they may instead be attached to a different layer of pericardial tissue which is in turn
`
`attached to the inner channel of the stent.” (Id.) Plaintiff emphasizes that “‘cusps’ or
`
`‘leaflets’ are merely part of the valve means.” (Id. at 9.)
`
`
`
`Defendant argues that “Medtronic’s construction is correct because it is entirely
`
`consistent with the specification, while Colibri’s construction improperly reads out an
`
`embodiment described in the specification.” (Def. CC Opening at 2.) Defendant notes
`
`that “there is no embodiment in the specification in which the valve is not attached to the
`
`stent in some manner.” (Id. at 3.) Defendant also argues that Plaintiff’s proposed
`
`construction should be rejected because “while the specification does describe some
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`embodiments having leaflets and a valve body that is attached to the stent, other
`
`11
`
`embodiments have only leaflets that are attached directly to the stent.” (Id.)
`
`12
`
`
`
`Plaintiff responds: “There is no dispute over the function of the valve—it is the
`
`13
`
`structure that opens and closes to allow the one-way flow of blood. The dispute is only
`
`14
`
`about which structures make up the valve.” (Pl. CC Response at 1.) Plaintiff argues that
`
`15
`
`“The specification is clear throughout that there are two primary portions of the valve:
`
`16
`
`leaflets and a tubular portion . . . .” (Id.) Plaintiff also argues that an alternative
`
`17
`
`embodiment cited by Defendant (see ’294 Patent at 9:8–24) refers to a “cuff portion”
`
`18
`
`being optional, not to the tubular portion being optional. (See Pl. CC Response at 2–5.)
`
`19
`
`Further, Plaintiff urges as to Defendant’s proposed construction that “[i]t is
`
`20
`
`unnecessarily vague and unhelpful to refer to ‘portions’ where the patent has given a
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 7
`
`
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 7 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 8 of 59 Page ID
`#:1912
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`specific name for structures that give rise to certain functions,” and “[t]he specification is
`
`clear that not every portion of the valve must attach directly to the stent.” (Id. at 5.)
`
`
`
`Defendant responds that “the specification also discloses a valve embodiment that
`
`includes only leaflets,” and “the leaflets in that embodiment are only preferably
`
`cylindrical – in other words, a cylindrical/tubular shape is not required in that
`
`embodiment for any structure, let alone a portion separate and apart from the leaflets.”
`
`(Def. CC Response at 2 (citing ’739 Patent at 9:17–24).) Defendant also submits:
`
`“Medtronic’s construction merely requires that some part of the valve allows the one-
`
`way flow of blood, and some part be attached to the stent. In some embodiments – as
`
`10
`
`Colibri correctly noted – those are different parts of the valve.” (Def. CC Response
`
`11
`
`at 2.)
`
`(2) Analysis
`
`Claim 1 of the ’739 Patent, for example, recites (emphasis added):
`
`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;
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 8
`
`
`
`
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 8 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 9 of 59 Page ID
`#:1913
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`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.
`
`The parties agree that the valve serves to allow only a one-way flow of blood. See
`
`
`
`’739 Patent at 8:49–51 (the leaflets of the valve “open in response to blood flow in one
`
`direction and close in response to blood flow in the opposite direction”). This is
`
`10
`
`consistent with a technical dictionary definition of “valve” submitted by Defendant:
`
`1 : a bodily structure (as the mitral valve) that closes temporarily a passage
`or orifice or permits movement of fluid in one direction only 2 : any of
`various mechanical devices by which the flow of liquid (as blood) may be
`started, stopped, or regulated by a movable part that opens, shuts, or
`partially obstructs one or more ports or passageways; also : the movable
`part of such a device
`
`(Def. CC Opening, Ex. 3, Merriam-Webster’s Medical Desk Dictionary 871 (revised
`
`ed.).)
`
`
`
`As to whether a “tubular portion” or “valve body” is necessarily required,
`
`Defendant notes disclosure of an embodiment in which a “cylindrical cuff portion” is
`
`optional:
`
`Although a preferred embodiment of the invention comprises a single piece
`of valve material folded to create the valve body and a leaflet-forming
`portion that has no cuts or sutures, the inventors have discovered that as
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 9
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 9 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 10 of 59 Page ID
`#:1914
`
`
`long as the leaflet portion of the valve itself is formed from a single piece of
`biocompatible valve material, the other portions of the valve can be formed
`by suturing of one or more separate pieces of material without losing the
`novel and improved qualities of the present invention. This allows for the
`valve to be made even stronger, more durable and easier to make. This
`alternate embodiment comprises a leaflet forming layer made of a single
`piece of valve material attached to a separate piece forming the valve body
`having a folded cuff portion. The single piece leaflet forming layer is
`preferably cylindrical in shape and can be formed with or without folding.
`In this embodiment the single piece leaflet layer can itself be attached to the
`stent with or without a cylindrical cuff portion. Attachment is preferably by
`suturing, particularly continuous single or double sutures.
`
`’294 Patent at 9:8–25 (emphasis added).
`
`
`
`Defendant argues that this amounts to disclosure that the “valve body” or “tubular
`
`portion” is optional, but this “cylindrical cuff portion” (see id.) does not appear to
`
`correspond to the “tubular portion” in Plaintiff’s proposed construction. Instead, this
`
`disclosure appears to have been intended to explain that a tubular portion—which
`
`Plaintiff persuasively argues (see Pl. CC Response at 2–3) and Defendant agrees (see
`
`Def. CC Opening at 4) corresponds to the “valve body”—could be formed together with
`
`the leaflet portion by folding a single piece of material or, alternatively, two or more
`
`pieces of material could be sutured together. See ’294 Patent at 9:8–25; see also id. at
`
`8:44–9:7. On balance, Defendant fails to identify any clear disclosure of an embodiment
`
`in which the tubular portion is omitted.
`
`
`
`Plaintiff also cites various disclosures regarding a “tubular portion,” such as the
`
`Summary of the Invention, which refers to a “preferred embodiment” in which a “valve”
`
`(also referred to as a “valve means,” the parties agree) includes a “cusp or leaflet
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 10
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 10 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 11 of 59 Page ID
`#:1915
`
`
`portion” and a “tubular portion”:
`
`The present invention is a replacement heart valve device and method of
`making same. The replacement heart valve device, in a preferred
`embodiment, 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. The cusp or leaflet portion of
`the valve means is formed by folding of the pericardium material preferably
`used to create the valve without cutting of slits to form leaflets or suturing
`or otherwise affixing of separate leaflet portions. Other forms of tissue and
`suitable synthetic materials can also be used for the valve, formed in a sheet
`of starting material. The folded design provides a number of advantages
`over prior designs, including improved resistance to tearing at suture lines.
`The cusps/leaflets open in response to blood flow in one direction and close
`in response to blood flow in the opposite direction. Preferably the tubular
`portion of the valve means contains the same number of cusps as the native
`valve being replaced, in substantially the same size and configuration. The
`outer surface of the valve means is attached to the stent member.
`
`’294 Patent at 4:63–5:15 (emphasis added).
`
`
`
`These references to a “cusp or leaflet portion” and a “tubular portion” appear in
`
`the Summary of the Invention section of the patents-in-suit. As a general matter,
`
`“[s]tatements that describe the invention as a whole are more likely to be found in certain
`
`sections of the specification, such as the Summary of the Invention.” C.R. Bard, Inc. v.
`
`U.S. Surgical Corp., 388 F.3d 858, 864 (Fed. Cir. 2004). Here, however, these
`
`statements in the Summary of the Invention expressly refer to “a preferred embodiment,”
`
`so these statements do not necessarily warrant a narrow construction of the terms “valve”
`
`and “valve means.” See Phillips, 415 F.3d at 1323 (“although the specification often
`
`describes very specific embodiments of the invention, we have repeatedly warned
`
`against confining the claims to those embodiments”).
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 11
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 11 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 12 of 59 Page ID
`#:1916
`
`
`
`
`The specification discloses a particular embodiment of “valve means 200” with a
`
`tubular portion and a leaflet portion:
`
`Referring to FIG. 1, the valve means 200 comprises a generally tubular
`portion 210 and, preferably, a peripheral upstanding cusp or leaflet portion
`220. The valve means 200 is disposed within the cylindrical stent member
`100 with the tubular portion 210 transverse of and at some acute angle
`relative to the stent walls. The diameter of the tubular portion 210 is
`substantially the same as the inside diameter of the stent member in its
`initial expanded configuration. The peripheral upstanding cusp or leaflet
`portion 220 is disposed on valve means 200 substantially parallel to the
`walls of the stent member similar to a cuff on a shirt. The cusp or leaflet
`portion 220 of the valve means 200 is generally tubular in shape and
`comprises three leaflets 221, 222 and 223 as shown, although it is
`understood that there could be from two to four leaflets. The tubular
`portion of the valve means 200 is attached to the stent member 100 by a
`plurality of sutures 300, as depicted in FIG. 7.
`
`The leaflet portion 220 of the valve means 200 extends across or transverse
`of the cylindrical stent 100. The leaflets 221, 222 and 223 are the actual
`valve and allow for one-way flow of blood. The leaflet portion 220 as
`connected to the rest of the valve resembles the cuff of a shirt. FIG. 9
`depicts the folds preferred for valve cusp and leaflet formation involving
`three leaflets.
`
`
`
`The valve means 200 is disposed within the cylindrical stent member 100
`with the tubular portion 210 transverse of and at some acute angle relative
`to the stent walls. The diameter of the tubular portion 210 is substantially
`the same as the inside diameter of the stent member 100 in its initial
`expanded configuration. The peripheral upstanding cusp or leaflet portion
`220 is disposed substantially parallel to the walls of the stent member 100
`similar to a cuff on a shirt.
`
`The cusp or leaflet portion 220 of the valve means 200 is formed by folding
`of the pericardium material used to create the valve. FIGS. 3A and 3B
`depict the way the sheet of heart valve starting material is folded. The
`starting material is preferably a flat dry sheet, which can be rectangular or
`
`
` * *
`
` *
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 12
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 12 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 13 of 59 Page ID
`#:1917
`
`
`other shaped. The cusps/leaflets 221, 222 and 223 open in response to
`blood flow in one direction and close in response to blood flow in the
`opposite direction. Preferably the cusp or leaflet portion 220 of the valve
`means 200 contains the same number of cusps as the native valve being
`replaced, in substantially the same size and configuration.
`
`Id. at 6:61–7:18 & 8:35–54 (emphasis added); see id. at Fig. 1. Figure 1 of the patents-
`
`in-suit is reproduced here:
`
`
`
`First, these disclosures, like the above-discussed statements in the Summary of the
`
`Invention, relate to a “preferred embodiment of the replacement heart valve device.” Id.
`
`
`
`at 6:54.
`
`
`
`Second, this disclosure states:
`
`The leaflet portion 220 of the valve means 200 extends across or transverse
`of the cylindrical stent 100. The leaflets 221, 222 and 223 [of cusp or
`leaflet portion 220] are the actual valve and allow for one-way flow of
`blood.
`
`
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 13
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 13 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 14 of 59 Page ID
`#:1918
`
`
`’294 Patent at 7:13–15 (emphasis added). This disclosure that the leaflets are the “actual
`
`valve” (id.) weighs against Plaintiff’s proposal that the terms “valve” and “valve means”
`
`must include not only structures that open and close to allow the one-way flow of blood
`
`but also a “tubular portion.” See Phillips, 415 F.3d at 1315 (“[T]he specification is
`
`always highly relevant to the claim construction analysis. Usually, it is dispositive; it is
`
`the single best guide to the meaning of a disputed term.”) (citation and internal quotation
`
`marks omitted).
`
`
`
`Also, the above-cited disclosures, such as regarding a “tubular portion,” weigh in
`
`favor of finding that the leaflets could be attached directly to the stent or could be
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`attached to a valve body that, in turn, is attached to the stent. See, e.g., ’294 Patent at
`
`11
`
`7:9–10 (“The tubular portion of the valve means 200 is attached to the stent member
`
`12
`
`. . . .”); id. at 9:6–7. In other words, there may be intermediate structures.
`
`13
`
`
`
`Further as to Plaintiff’s proposal of requiring a “tubular portion,” at the
`
`14
`
`February 1, 2021 hearing Plaintiff was amenable to modifying its proposed construction
`
`15
`
`by replacing “tubular portion” with “valve body.” To whatever extent this discussion
`
`16
`
`during the hearing does not moot Defendant’s argument that the valve body could be
`
`17
`
`other than tubular, the Technical Special Master hereby expressly rejects any
`
`requirement that the “valve” must necessarily be “tubular” or must necessarily have a
`
`“tubular” subcomponent. For example, although above-reproduced Claim 1 of the ’739
`
`Patent recites a stent including a “tubular structure,” no “tubular” valve body
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 14
`
`
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 14 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 15 of 59 Page ID
`#:1919
`
`
`requirement is apparent from the claim language or any of the other evidence discussed
`
`by the parties, and disclosures regarding a “tubular portion” pertain to specific features
`
`of particular disclosed embodiments that should not be imported into the claims. See
`
`Phillips, 415 F.3d at 1323.
`
`
`
`Finally, the parties have discussed whether material that wraps around the
`
`structure of a stent (thus extending outside of the stent) is part of the “valve.” (See Pl.
`
`CC Opening at 10 (“Medtronic’s citation to non-accused, additional structure cannot
`
`defeat infringement.”).) The parties discussed this issue during the February 1, 2021
`
`hearing, and the Technical Special Master permitted supplemental briefing on the issue.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`(See Dkt. 90-1, Feb. 2, 2021 Order No. TSM-4.) Because the arguments on this issue are
`
`11
`
`directed primarily to the “residing entirely within” terms (which are construed separately
`
`12
`
`herein), this Report and Recommendation addresses this material-outside-of-the-stent
`
`13
`
`issue as part of the analysis of the “residing entirely within” terms instead of as part of
`
`14
`
`the construction of “valve” and “valve means.”
`
`15
`
`
`
`Based on all of the foregoing, the Technical Special Master hereby construes
`
`16
`
`“valve” and “valve means” to mean “portions of the replacement heart valve device
`
`that allow the one-way flow of blood.”
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 15
`
`
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 15 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 16 of 59 Page ID
`#:1920
`
`
`B. “residing entirely within an inner channel of the stent member” and “resides
`
`entirely within the inner channel of the stent member”
`
`Plaintiff’s Proposed Construction Defendant’s Proposed Construction
`
`all portions of the valve means/valve are
`located completely within the inner channel
`of the stent such that no portion of the
`valve means/valve is even partially located
`outside of the inner channel of the stent
`
`The valve / valve means is entirely
`within the length of the inner
`channel of the stent member.
`
`Supplemental Proposal:
`all portions of the valve are
`entirely within the inner channel of
`the stent member, but not all
`pericardial tissue necessarily is part
`of the valve
`
`
`(JCCC at 1; Def. CC Opening at 1; Def. CC Response at 1; see Pl. CC Opening at 11;
`
`see also Pl. CC Response at 6; Pl. Suppl. Opening at 1.) The parties submit that these
`
`terms appear in Claim 1 of the ’294 Patent and Claim 1 of the ’739 Patent. (JCCC at 1.)
`
`
`
`The parties agree that these two terms “should have a single, common
`
`construction.” (Pl. CC Opening at 3–4.)
`
`
`
`
`
`(1) The Parties’ Positions
`
`Plaintiff submits that its proposed construction is consistent with what is shown in
`
`Figures 5 and 6 of the patents-in-suit and is supported by the prosecution history of the
`
`patents-in-suit. (Pl. CC Opening at 11–14.) Plaintiff argues that Defendant’s proposed
`
`construction is inconsistent with the prosecution history. (Id. at 14–15; see id. at 12–14.)
`
`
`
`Defendant argues that its proposed construction “requires that all of the valve
`
`must be located inside the inner channel of the stent—that is simply what ‘entirely
`
`
`TECHNICAL SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2025, Page 16 of 59
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 97-1 Filed 02/11/21 Page 17 of 59 Page ID
`#:1921
`
`
`within’ means. In contrast, Colibri’s construction