`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`
`Patent Owner.
`
`
`
`
`
`SUPPLEMENTAL DECLARATION OF
`STEPHEN JON DAVID BRECKER, MD, FRCP, FESC, FACC
`SUBMITTED IN SUPPORT OF PETITIONER’S REPLIES
`
`
`
`
`
`i
`
`
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1806
`Medtronic v. Teleflex
`
`Page 1
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`

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`
`
`Table of Contents
`
`Page
`
`Table of Contents ....................................................................................................... 2
`I.
`Overview .......................................................................................................... 4
`II.
`Claim Construction .......................................................................................... 4
`A.
`“interventional cardiology devices” ...................................................... 4
`
`B.
`
`C.
`
`“coaxial” ................................................................................................ 9
`
`Claim 25 of the ʼ380 Patent ................................................................. 14
`
`III.
`
`Claim 25: “Means for Receiving and Guiding” ....................... 14
`1.
`Claim 25: “Interventional Device” ........................................... 19
`2.
`Itou-Based Grounds .......................................................................................20
`A.
`Types of interventional cardiology devices insertable through
`catheter (2) ........................................................................................... 20
`
`B. Distal end protective catheter (5) ........................................................ 24
`
`C.
`
`D.
`
`E.
`
`Itou and Ressemann as prior art .......................................................... 25
`
`Itou and Ressemann collar 2141 ......................................................... 29
`
`Itou and Kataishi ................................................................................. 34
`
`IV. Ressemann-Based Grounds ...........................................................................36
`A.
`Ressemann discloses a “tubular structure defining a lumen
`coaxial and in fluid communication with the lumen of the guide
`catheter” ............................................................................................... 36
`
`B.
`
`C.
`
`D.
`
`E.
`
`Ressemann in view of Takahashi ........................................................ 39
`
`Ressemann collar 2141 ........................................................................ 42
`
`Ressemann anticipates the means-plus-function claims of the
`’380 patent ........................................................................................... 45
`
`Ressemann or Itou + Kataishi renders claim 27 of the ’380
`patent obvious ...................................................................................... 49
`
`2
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`Page 2
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`V.
`
`Kontos-Based Grounds ..................................................................................50
`A.
`Tube 16 of Kontos’s body 12 is not a narrow tube ............................. 50
`
`B.
`
`Body 12 of Kontos’s support catheter 10 has a “cross-sectional
`inner diameter through which interventional cardiology devices
`are insertable” ...................................................................................... 55
`
`C. Kontos necessarily resists axial and shear forces that would
`otherwise tend to dislodge the guide catheter. .................................... 57
`
`D.
`
`The side opening claims are obvious. ................................................. 61
`
`1.
`
`2.
`
`Replacing Kontos’s proximal funnel with a side opening would
`maximize the usable “real estate” inside the catheter
`assembly. ................................................................................... 61
`After removing Kontos’s proximal funnel, a posita would have
`been motivated to maximize the usable real estate, but even if
`no further modifications were made, Kontos would not have a
`“problem gap.” .......................................................................... 65
`After removing Kontos’s proximal funnel, Kontos’s support
`catheter 10 would remain coaxial with the guide catheter. ....... 69
`Even under patent owner’s interpretation, Kontos still has a
`“flexible cylindrical reinforced portion.” ............................................ 72
`
`3.
`
`E.
`
`F.
`
`A POSITA would have been motivated with a reasonable
`expectation of success to achieve the no-more-than-one-french
`differential between inner diameters of the guide catheter and
`body 12. ............................................................................................... 73
`
`G. My opinion remains unchanged: the claims of the ʼ776 patent
`that recite a two-inclined side opening are obvious. ........................... 76
`
`Kontos + Ressemann and Kontos + Ressemann + Takahashi .. 76
`1.
`Kontos + Ressemann + Kataishi ............................................... 78
`2.
`VI. Teleflex’s Evidence Regarding Secondary Considerations Does Not Alter
`My Opinion That the Challenged Claims Are Obvious. ...............................80
`VII. Conclusion .....................................................................................................83
`
`
`
`3
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`Page 3
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`I.
`
`Overview
`
`1.
`
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinions concerning U.S. Patent Nos. 8,048,032; RE45,380;
`
`RE45,776; RE45,760; and RE47,379 (the “Teleflex Patents”) in IPR2020-00126,
`
`IPR2020-00127, IPR2020-00128, IPR2020-00129, IPR2020-00130, IPR2020-
`
`00132, IPR2020-00134, IPR2020-00135, IPR2020-00136, IPR2020-00137 and
`
`IPR2020-00138.1
`
`2.
`
`I set forth the information below as a supplement to my original
`
`declarations, as Teleflex raised new issues in their Patent Owner Responses on
`
`which I had not previously been given an opportunity to offer testimony. Having
`
`considered Teleflex’s arguments, and the testimony of Teleflex’s declarants, my
`
`opinions on the invalidity of the Teleflex Patents remain the same.
`
`II. Claim Construction
`
`“interventional cardiology devices”
`
`The opinions in this section generally relate to at least the following
`
`A.
`
`3.
`
`IPRs:
`
`
`1 Citations to exhibits refer to exhibits filed in IPR2020-00126, unless noted
`
`otherwise. I understand that most of Patent Owner’s and Petitioners’ exhibits are
`
`numbered consistently across all seven IPRs.
`
`4
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`Page 4
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` IPR2020-00126 (’032 patent)
`
` IPR2020-00127 (’032 patent)
`
` IPR2020-00128 (’380 patent)
`
` IPR2020-00130 (’380 patent)
`
` IPR2020-00135 (’776 patent)
`
`4.
`
`I am aware that when the Board instituted the IPR2020-00126 ’032
`
`petition it considered whether the limitation “interventional cardiology devices”
`
`required that “all four enumerated devices (guidewires, balloon catheters, stents
`
`and stent catheters)” be insertable into the lumen of the claimed “device for use
`
`with a standard guide catheter.” I.D., Paper 22, 10-13 (IPR2020-00126). This
`
`limitation appears in independent claims 1 and 11. This limitation also appears in
`
`claims 1 and 12 of the ’380 patent. (See I.D., Paper 22, 9-11) (IPR2020-00128).
`
`5.
`
`At institution, the Board determined that “interventional cardiology
`
`devices” refers to “at least two types of the devices selected from the group that
`
`includes but is not limited to guidewires, balloon catheters, stents, and stent
`
`catheters.” I.D., Paper 22, 12 (IPR2020-00126). Additionally, it determined that
`
`Medtronic demonstrated that the tubular portion of Itou’s catheter (2) has an inner
`
`diameter through which both guidewire (6) and distal end protective catheter (5)
`
`may be inserted. Id., 20.
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`5
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`6.
`
`I have reviewed Teleflex’s claim construction arguments, POR, 9-14
`
`(IPR2020-00126) (citing Ex-2138 (Declaration of Peter Keith) and Ex-2145
`
`(Declaration of Doctor John J. Graham)); POR, 7-10 (IPR2020-00135) (same), and
`
`I disagree.
`
`7.
`
`First, I disagree that claims 1 and 11 (’032 patent) or 1 and 12 (’380
`
`patent) require that “at least the set of four devices . . . guidewires, balloon
`
`catheters, stents, and stent catheters” be insertable into the claimed lumen. POR, 9
`
`(IPR2020-00126). I have reviewed the Teleflex patent and do not see that the
`
`claims require this. The claims do not, for example, recite “all interventional
`
`cardiology devices,” or “at least four interventional cardiology devices.”
`
`8.
`
`Second, I disagree that “interventional cardiology devices” should be
`
`construed to be limited to the four enumerated devices and to “any other device
`
`that is delivered beyond the end of the device for use with a standard guide catheter
`
`to a location in the coronary vasculature requiring treatment, to provide treatment
`
`to that location.” 2 POR, 11 (IPR2020-00126).
`
`9.
`
`I understand Teleflex’s argument to be, in part, that the patent
`
`specification uses the terms “cardiac treatment device” and “interventional
`
`
`2 For example, it is my opinion that the distal protection device described in Adams
`
`(Ex-1035 IPR2020-00126) is an interventional cardiology device.
`
`6
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`Page 6
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`cardiology treatment device” interchangeably with “interventional cardiology
`
`device[s].” POR, 12 (IPR2020-00126). I disagree that the patent uses these three
`
`terms as synonyms. The specification does not limit its discussion to treatment
`
`devices, or even to treatment devices and catheters that deliver those devices. For
`
`example, it explains that “[i]n order to diagnose and treat obstructive coronary
`
`artery disease it is commonly necessary to pass a guidewire or other instrument
`
`through and beyond the occlusion or stenosis of the coronary artery.” Ex-1001,
`
`1:26-29. And it also discusses that “the interventional cardiology art would benefit
`
`from the availability of a system that would be deliverable through standard guide
`
`catheters for providing backup support . . . .” Id., 2:45-49; and see, id., 1:7-8
`
`(describing the invention relating generally to catheters used in interventional
`
`cardiology procedures).
`
`10.
`
`I understand a “cardiac treatment device” and an “interventional
`
`cardiology treatment device” to be subsets of the broader term “interventional
`
`cardiology device[s].” A POSITA understands an “interventional cardiology
`
`device” as a much more general term to include devices that might be placed in the
`
`coronary artery that are not actually treatment devices themselves, for example
`
`intracoronary imaging catheters. However, a POSITA would not even limit the
`
`term “interventional cardiology device” in general only to the coronary arteries.
`
`There is an entire subspecialty within interventional cardiology for non-coronary
`
`7
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`interventions. Examples of interventional cardiology devices that are not placed in
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`a coronary artery would include, for example, intracardiac echocardiography
`
`catheters used for imaging the heart, percutaneous femoral closure devices,
`
`external vascular hemostasis devices, cardiac septal closure devices and cerebral
`
`protection devices amongst many others.
`
`11. Similarly, not even every intracoronary “interventional cardiology
`
`device” is used to provide treatment. Devices in this category include intravascular
`
`ultrasound catheter used for imaging the vessel, optical coherence tomography
`
`catheter used for imaging the vessel and fractional flow reserve measurement
`
`“pressure” wires. These devices are for diagnosis not treatment.
`
`12. As illustrated below, an “interventional cardiology treatment device”
`
`is but a subset of “interventional cardiology device(s).”
`
`
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`8
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`13. Only a subset of the devices specifically identified in the specification
`
`provide treatment. A guidewire does not provide treatment. It instead “provide[s] a
`
`rail over which a series of therapeutic devices can be advanced.” Ex-1015, 95. Dr.
`
`Graham’s testimony supports this. He acknowledges that a guidewire is used in
`
`conjunction with a stent or balloon in order to treat an occlusion. Ex-1801, 89:2-
`
`23.
`
`IPRs:
`
`B.
`
`“coaxial”
`
`14.
`
`The opinions in this section generally relate to at least the following
`
` IPR2020-00127 (ʼ032 Patent)
`
` IPR2020-00130 (ʼ380 Patent)
`
` IPR2020-00134 (’760 Patent)
`
`15.
`
`I understand that Teleflex disputes that Ressemann discloses “a
`
`“tubular structure defining a lumen coaxial and in fluid communication with the
`
`lumen of the guide catheter.” POR, 9-13 (IPR2020-00134) (citing Ex-2138
`
`(Declaration of Peter Keith) and Ex-2145 (Declaration of Doctor John J. Graham)).
`
`Teleflex’s position is that Ressemann’s evacuation sheath includes an evacuation
`
`head with a “multi-lumen tube,” and, as such, the lumen of the tubes are not
`
`coaxial with the lumen of the guide catheter because neither is perfectly concentric
`
`9
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`with the lumen of the guide catheter. The images below are reproduced from
`
`Teleflex’s brief and Mr. Keith’s Declaration.
`
`IPR2020-00134, POR at 12; Ex-2138, 65-66.
`
`16.
`
`I disagree. A POSITA does not understand “coaxial” to refer to
`
`perfect concentricity, so that the catheters share exactly the same center line. I have
`
`reviewed the deposition testimony of Mr. Keith, who, now, agrees with this. Ex-
`
`1764, 91:10-18; 94:11-19; Ex-1800, 23:19-24:1; Ex-1805, 107:19-109:6; 117:14-
`
`121:1.
`
`17.
`
`Besides reciting the coaxial arrangement articulated above, the
`
`claims also recite that the guide catheter is positioned adjacent the coronary
`
`ostium, and the guide extension catheter is inserted into the guide catheter to be
`
`advanced through it and partially into the coronary artery. This configuration
`
`allows for the guide extension to receive a stent or balloon catheter. Ex-1601, claim
`
`25 (IPR2020-00134).
`
`10
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`18.
`
`This is similar to the disclosure in the patent, which shows a guide
`
`extension catheter inserted into a guide catheter, where the two are in line with the
`
`coronary artery. Id., Fig. 8; 8:10-16.
`
`19.
`
`I am aware that Mr. Keith offered a definition of “coaxial” during
`
`his deposition, which is that “coaxial means essentially a tube-in-a-tube
`
`arrangement that is relatively close-fitting.” Ex-1764, 98:18-21. He was not,
`
`however, able to specify how close fitting “relatively close-fitting” is. Id., 98:22-
`
`99:12. He also testified that his opinion was that the tubes themselves have “radial
`
`symmetry,” id., 101:20, but I see nothing in the patent claims or specification that
`
`would require radial symmetry of the tubes themselves.
`
`20. While the specification describes a 1 French relationship between
`
`the guide catheter and guide extension catheter, not all of the claims of all of the
`
`patents require this. Compare, e.g., ’760 patent (cl. 25, 13:6061) with ’380 patent
`
`(cl. 1), ’032 patent (cl. 1). Thus, “coaxial” cannot require a 1 French differential
`
`between the lumen of the guide extension catheter and the lumen of the guide
`
`catheter. Dr. Graham, Teleflex’s cardiologist, agrees. Ex-1801, 37:22-28:2. So does
`
`Mr. Keith, who testified that a 4-in-6 or a 5-in-7 relationship would still be coaxial.
`
`Ex-1800, 23:19-24:1; Ex-1805, 119:4-121:1.
`
`11
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`Ex-1117.
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`
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`21.
`
`The import of these relationships is shown below. The larger the
`
`differential between the OD of the extension catheter and the ID of the guide
`
`catheter, the more room there is within the guide catheter for the extension catheter
`
`to drift off-center, such that its axis is not perfectly concentric with that of the
`
`guide catheter.
`
`22.
`
`The schematics below illustrate a 6 French guide catheter described
`
`in the patent, which teaches that 6 French guide catheters have IDs of > 0.070
`
`inches. Ex-1601, 3:42-44 (IPR2020-00134).
`
`23.
`
`On the left, the guide extension catheter is 5 French, which a
`
`POSITA understands to correspond to 5 x (0.33) = 1.65 mm, which is 0.065 inches.
`
`On the right, the guide extension catheter is 4 French, which a POSITA
`
`understands is 4 x (0.33) = 1.32 mm = 0.052 inches.
`
`12
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`24.
`
`Thus, “coaxial” must encompass both what the specification
`
`discloses for a 5-in-6 relationship (an 0.005 inch annular gap), as well as the
`
`admitted 4-in-6 relationship (an 0.18 inch annular gap). This is consistent with the
`
`understanding of a POSITA. E.g. Ex-1840, 1 (describing using a 4 Fr angiographic
`
`catheter within a 6 Fr guide catheter in a coaxial fashion); Ex-1841, 1 (describing a
`
`coaxial double catheter technique using an 8 Fr guide catheter and a 5 Fr
`
`diagnostic catheter).
`
`25.
`
`I am also aware that one of the inventors, Mr. Root, testified
`
`
`
`
`
`68:2 86:1-87:7; Ex-2015, 37:10-17. This is also consistent with the testimony of
`
`Teleflex’s experts, as well as the understanding of a POSITA.
`
` Ex-1114, 66:22-
`
`13
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`26. Given the claims and specification of the patent, consistent with the
`
`understanding of a POSITA, “coaxial” means the lumens are aligned. Specifically,
`
`it means that the “axis of the lumen of the guide extension catheter is aligned in the
`
`same direction as the axis of the lumen of the guide catheter.”
`
`C. Claim 25 of the ʼ380 Patent
`
`27.
`
`The opinions in this section generally relate to at least the following
`
`IPRs:
`
` IPR2020-00134 (’760 Patent)
`
`1.
`
`Claim 25: “Means for Receiving and Guiding”
`
`28.
`
`Claim 25 of the ʼ380 patent recites a “means for receiving an
`
`interventional device . . . and guiding the interventional device deeper into the
`
`branch vessel.” After the means limitation, “claim 25 provides an extensive
`
`recitation of structure.” I.D., Paper 22, 18 (IPR2020-00129). I understand that at
`
`Institution, the Board explained that “[w]hether the structure identified in claim 25
`
`are sufficient to perform the two recited functions of the means for receiving and
`
`guiding … is a disputed, material issue of fact …. [that] is best resolved upon a full
`
`trial record.” Id., 18. Having reviewed the testimony of Mr. Keith and Dr. Graham,
`
`I still believe that claim 25 recites sufficient structure to overcome the means-plus-
`
`function presumption.
`
`14
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`a.
`
`The means-plus-function presumption is overcome because
`Claim 25 recites sufficient structure.
`
`29.
`
`I have been informed by counsel that if a “means” claim recites
`
`sufficient structure for performing the claimed function, then that limitation is not
`
`a means-plus-function limitation.
`
`30.
`
`I understand that Mr. Keith and Dr. Graham believe that the means-
`
`plus-function presumption for claim 25 is not overcome because the claim
`
`language allegedly “does not recite that the tip portion and the reinforced portion
`
`have a lumen that communicates with the claimed opening into which an
`
`interventional device can be received and be guided ‘deeper into the branch
`
`vessel.’” Ex-2138, ¶ 108 (IPR2020-00129); Ex-2145, ¶ 97 (IPR2020-00129). I
`
`disagree and believe that a POSITA reviewing just the language of claim 25 would
`
`conclude that the reinforced portion and tip portion have a lumen.
`
`31.
`
`Although Mr. Keith agrees that the distal end of the claimed side
`
`opening has a full circumference portion, he believes structure is still lacking from
`
`claim 25 because “[t]here is no claim language requiring a lumen extending
`
`through the reinforced portion and the tip portion.” Ex-2138, ¶109 (IPR2020-
`
`00129). I do not agree with Mr. Keith’s assessment. Mr. Keith’s conclusion does
`
`not make sense, as there would be no reason to have a side opening if its lumen
`
`terminated prior to the reinforced and tip portions. I am unaware of any catheter
`
`assembly (i.e., means for receiving and guiding) having a side opening where the
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`lumen terminates prior to the distally-located portions (i.e., the sections found
`
`distal to the side opening). In my opinion, there would be no reason to have a side
`
`opening if the lumen terminated prior to the distally-located portion(s). I cannot
`
`think of any function or reason to have a catheter assembly with a side opening that
`
`terminates into a lumenless portion.
`
`32.
`
`Further, by the time of the alleged invention, reinforcing catheters—
`
`in particular, with metallic braiding or coiling—was common practice in the art.
`
`E.g. Ex-1008, 7:4-7. The reason for reinforcement is to allow the catheter to
`
`maintain its shape in regions of tortuosity and calcification. E.g. id., 6:66-7:4. In
`
`other words, by recited the claim language “reinforced portion,” a POSITA would
`
`have understood that a lumen was found therein, otherwise there would be no need
`
`for reinforcement.
`
`33.
`
`A POSITA would also expect the tip portion to have a lumen. This is
`
`especially true because if the side opening and reinforced portion both have
`
`lumens, it would be illogical for the tip portion to not also have a lumen (i.e., dead
`
`end). Further, a POSITA knows that the only way to receive and guide a device
`
`into the vasculature would require the tip portion to have a lumen. As a result,
`
`based on the claim language alone, I believe that claim 25 describes that the
`
`reinforced and tip portions have a lumen, and the means-plus-function presumption
`
`is overcome.
`
`16
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`34.
`
`I do not believe it is necessary to do so here, but the specification of
`
`the ʼ380 patent, if consulted, reinforces my conclusion that the means-plus-
`
`function presumption is overcome. For example, each Figure showing the
`
`reinforced portion 18 or the tip portion 16 show a lumen. See Ex-1001, Figs. 1, 3,
`
`4. The specification also explains that interventional devices are “inserted through
`
`the lumen of coaxial guide catheter 12.” Id., 10:16-20. And “[t]he coaxial guide
`
`catheter includes a tip portion, a reinforced portion, and a substantially rigid
`
`portion.” Id., 4:51-53. There are no examples or discussion of a lumenless
`
`reinforced portion or tip portion in the specification of the ʼ380 patent. In other
`
`words, if the specification of the ʼ380 patent is considered, it further supports my
`
`conclusion that the reinforced and tip portion of claim 25 have a lumen.
`
`Accordingly, I am still of the opinion that the means-plus-function-presumption is
`
`overcome.
`
`b.
`
`If the means-plus-function presumption is not overcome, the
`corresponding structure is an extension catheter lacking the
`unnecessary structure added by PO.
`
`35.
`
`If the means-plus-function presumption is not overcome, the
`
`corresponding structure for the means for receiving and guiding is an extension
`
`catheter.
`
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`36.
`
`I understand that Mr. Keith and Dr. Graham agree that the
`
`corresponding structure in the specification is a guide catheter, but they believe that
`
`the guide catheter must also have the following structure:
`
`a distal tubular portion with a single lumen3 that is coaxial with the
`
`lumen of the guide catheter attached to a substantially rigid rail
`
`structure that allows interventional devices to be advanced alongside
`
`and into the lumen of the tubular portion, with the total length of the
`
`device being longer than the guide catheter, and at least a distal part
`
`of the tubular portion is flexible.4
`
`Ex-2138, ¶114 (IPR2020-00129) (emphasis added); Ex-2145, ¶¶99-100 (IPR2020-
`
`00129).
`
`37.
`
`I have been informed by counsel that when identifying the
`
`corresponding structure, a POSITA should only incorporate structure that is
`
`necessary to perform the claimed function. Here the claimed function is “receiving
`
`the interventional device from an intermediate or distal portion of the [guide
`
`catheter . . . and guiding the interventional device deeper into the branch vessel.”
`
`
`3 I note that the specification never affirmatively states that the described guide
`
`catheter is limited to a single lumen.
`
`4 For ease of discussion, I refer to the extension catheter with Patent Owner’s
`
`additional recitation of structure as “Extension Catheter + Structure.”
`
`18
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`Ex-1001, claim 25 (IPR2020-00129). To perform this means for receiving and
`
`guiding, I do not believe that the additional structure recited by Patent Owner is
`
`necessary. In particular, I do not agree with Patent Owner’s position that the
`
`receiving and guiding function requires an extension catheter with a coaxial tubular
`
`portion and a single lumen.
`
`38.
`
`For example, Ressemann is an example of a non-coaxial (under
`
`Patent Owner’s construction),5 multi-lumen catheter that receives and guides an
`
`interventional device. Ex-1008, Figs. 6A-6F.
`
`39.
`
`As a result, if the means-plus-function is not overcome, the
`
`corresponding structure for the means for receiving and guiding is a guide catheter
`
`that does not include Patent Owner’s additional recitation of structure.
`
`2.
`
`Claim 25: “Interventional Device”
`
`40. Other than in claim 25 (and its dependent claims), the phrase
`
`“interventional device” is not used in the ʼ380 patent. The plain and ordinary
`
`meaning of an “interventional device” is any device used in an interventional
`
`
`5 As set forth above, I disagree with Patent Owner’s construction of coaxial.
`
`§ II(B), supra. It is my opinion that Ressemann’s evacuation assembly is coaxial to
`
`the guide catheter. See, e.g., § IV(A), infra.
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`procedure. Under this definition, Itou’s protective catheter 5 is an interventional
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`device.
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`III.
`
`Itou-Based Grounds
`
`41. For the purpose of my analysis I have been asked to assume that Itou
`
`is prior art to the Teleflex patents.
`
`A. Types of interventional cardiology devices insertable through
`catheter (2)
`
`42.
`
`The opinions in this section generally relate to at least the following
`
`IPRs:
`
` IPR2020-00126 (’032 patent)
`
` IPR2020-00128 (’380 patent)
`
` IPR2020-00129 (ʼ380 patent)
`
` IPR2020-00132 (’760 patent)
`
` IPR2020-00135 (’776 patent)
`
`43. Assuming that the claims are construed to require that two
`
`interventional cardiology devices must be insertable through the claimed lumen,
`
`Itou satisfies this limitation.
`
`44. Even if Teleflex were correct both as to its claim construction position
`
`and as to the “effective size” of the tubular structure of catheter (2) being 0.046
`
`inches (and I disagree for the reasons discussed below), Itou nonetheless inherently
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`discloses a lumen through which all four, enumerated interventional cardiology
`
`devices (guidewires, balloon catheters, stents and stent catheters) are insertable.
`
`45.
`
`Itou teaches that guidewire (6) is insertable through the lumen of
`
`catheter (2). Ex-1007, Fig. 5; 4:64-65; 5:11-20. Guidewires were known to range in
`
`size from 0.010 to 0.018 inches. Ex-1015, 98. They would therefore be insertable
`
`through catheter (2) even if its “effective size” were 0.046 inches.
`
`46. Similarly, even if the “effective size” of the opening to the lumen of
`
`catheter (2) were 0.046 inches, angioplasty catheters were known to be insertable
`
`through catheters with lumen of 0.045 inches. Ex-1009, 4:49-63; Ex-1833, 1.
`
`47.
`
`There were also a variety of stents with crossing profiles that were
`
`small enough to be advanced through a lumen of 0.046 inches (1.16 mm) that I
`
`discuss below. Necessarily, each of the stents that are discussed were advanced into
`
`the coronary vasculature on a “stent catheter.”
`
`48. Baim explains that “[a]ll current slotted tube designs are ‘bare
`
`mounted’ on a delivery balloon, with deflated profiles smaller than 0.040-in.
`
`(1mm)” Ex-1015, 189.
`
`49.
`
`The 4th edition of the Handbook of Coronary Stents disclosed the
`
`following: at pp. 4, 7 (balloon-expandable Genic® stent with less than 0.9 mm
`
`(0.035 inch) profile), 15-16 (balloon-mounted Lunar stent with 0.0382 inch
`
`profile), 21 (Spiral Force stent with 0.039 to 0.042 inch profile and “Runner” stent
`
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`delivery balloon catheter), 25 (balloon-expandable Tsunami stent with 0.95 mm
`
`(0.038 inch) profile). Ex-1802.
`
`50.
`
`Similarly, US Pat. No. 6,726,714 taught a stent crimped against a
`
`balloon with a “relatively small loaded diameter having an OD of 0.44 inches.” Ex-
`
`1803, 4:54-56.
`
`51. And an article by Colombo described several balloon-expandable
`
`stents with crossing profiles well under 0.046 inches, including those with profiles
`
`of 0.99 mm (0.038 inch), 0.93 mm (0.036 inch) and 0.84 mm (0.033 inch)). Ex-
`
`1804, Table 1; Fig. 3.
`
`52.
`
`In sum, all of the devices I describe above are insertable through
`
`catheter (2), even if the “effective size” of its opening was 0.046 inches (1.16 mm)
`
`(3.48 Fr). I disagree, however, that the lumen of catheter (2) has an effective size of
`
`0.046 inches.
`
`53. Teleflex’s argument that Itou’s catheter (2) does not have a lumen that
`
`is 1.5 mm (0.059 inches), as Itou teaches in Table 1, but, instead is effectively only
`
`1.16 mm (0.046 inches) is based on the idea that because Itou’s wire (25) has a
`
`diameter of 0.45 mm (0.004 inches), it partially blocks the opening to lumen (2).
`
`Ex-2138, ¶129 (IPR2020-00126).
`
`54.
`
`This calculation does not make sense to a practicing interventional
`
`cardiologist. It assumes, first, that catheter (2) is entirely rigid, such that wire (25)
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`cannot be bent away from the angled proximal opening of the tubular portion of
`
`catheter (2).
`
`55.
`
`Itou explicitly teaches this is not the case, as it discloses that catheter
`
`(2)—and in particular its distal tubular portion— must be navigated into the
`
`coronary vasculature. Ex-1007, Abstract (“[A]ssembly is insertable into a blood
`
`vessel . . . .”); 1:66-2:5 (teaching that catheter is advanced to a “deep location in a
`
`coronary artery”); Fig. 6; 5:29-42. This means that catheter (2) is necessarily
`
`flexible, including in the region of the junction between the distal end of wire 25
`
`and the proximal part of catheter (2)’s tubular structure. A POSITA understands
`
`that an interventional cardiology device may be introduced into catheter (2) at an
`
`angle.
`
`56. Additionally, Itou teaches that wire (25) is flattened at its distal most
`
`end, “crushed into the form of a flat plate.” Ex-1007, 4:33-36. This is an additional
`
`reason that a POSITA would not understand that wire 25 reduces the effective size
`
`of the opening of the tubular portion of catheter (2). The flattened area adjacent to
`
`the proximal opening —in conjunction with catheter (2)’s flexibility—means that
`
`the entirety of the opening of catheter (2) will be accessible.
`
`57. My opinion that the claims of the ’032, ’380, ’760, and ’776 patents
`
`are invalid remains unchanged.
`
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`IPRs:
`
`B. Distal end protective catheter (5)
`
`58.
`
`The opinions in this section generally relate to at least the following
`
` IPR2020-00126 (’032 patent)
`
` IPR2020-00128 (’380 patent)
`
` IPR2020-00129 (ʼ380 patent)
`
` IPR2020-00135 (’776 patent)
`
`59.
`
`Itou describes inserting catheter (5) into catheter (2), and then
`
`advancing the two catheters, together, into guiding catheter (1) and into the
`
`vasculature. Ex-1007, 5:43-46; 7:13-18. In practice, however, a POSITA would
`
`advance catheters (2) and (5) together, until catheter (2) was in a desired location.
`
`As taught by Itou, catheter (5) would be withdrawn before catheter (2) would be
`
`used, either for suction, or to deliver a different interventional cardiology device.
`
`60. Not uncommonly during a procedure an interventional cardiologist
`
`will find that he needs to advance a catheter more deeply into the vasculature. In
`
`this instance, catheter (2) would be left in place, and catheter (5) would be re-
`
`introduced by insertion into the guide catheter, and advancement into catheter (2),
`
`while catheter (2)’s proximal opening remained in the guide catheter. Only then
`
`would it be safe to maneuver catheter (2) to a deeper location.
`
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`61. Sequential delivery would be an obvious alternative to preassembly,
`
`albeit not routine.
`
` Ex-1115, 165:3-25.
`
`
`
`62. My opinion that the claims of the ’032, ’380, and ’776 patents are
`
`invalid remains unchanged.
`
`Itou and Ressemann as prior art
`
`The opinions in this section generally relate to at least the following
`
`C.
`
`63.
`
`IPRs:
`
` IPR2020-00126 (’032 patent)
`
` IPR2020-00128 (’380 patent)
`
` IPR2020-00132 (’760 Patent)
`
` IPR2020-00135 (’776 patent)
`
` IPR2020-00137 (’379 patent)
`
`64.