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`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
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`
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1806
`Medtronic v. Teleflex
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`Page 1
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`
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`
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`Table of Contents
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`Page
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`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.
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`Itou and Ressemann as prior art .......................................................... 25
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`Itou and Ressemann collar 2141 ......................................................... 29
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`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
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`2
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`Page 2
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`V.
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`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
`
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`3
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`Page 3
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`I.
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`Overview
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`1.
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`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
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`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
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`provide my opinions concerning U.S. Patent Nos. 8,048,032; RE45,380;
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`RE45,776; RE45,760; and RE47,379 (the “Teleflex Patents”) in IPR2020-00126,
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`IPR2020-00127, IPR2020-00128, IPR2020-00129, IPR2020-00130, IPR2020-
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`00132, IPR2020-00134, IPR2020-00135, IPR2020-00136, IPR2020-00137 and
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`IPR2020-00138.1
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`2.
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`I set forth the information below as a supplement to my original
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`declarations, as Teleflex raised new issues in their Patent Owner Responses on
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`which I had not previously been given an opportunity to offer testimony. Having
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`considered Teleflex’s arguments, and the testimony of Teleflex’s declarants, my
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`opinions on the invalidity of the Teleflex Patents remain the same.
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`II. Claim Construction
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`“interventional cardiology devices”
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`The opinions in this section generally relate to at least the following
`
`A.
`
`3.
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`IPRs:
`
`
`1 Citations to exhibits refer to exhibits filed in IPR2020-00126, unless noted
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`otherwise. I understand that most of Patent Owner’s and Petitioners’ exhibits are
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`numbered consistently across all seven IPRs.
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`4
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`Page 4
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` IPR2020-00126 (’032 patent)
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` IPR2020-00127 (’032 patent)
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` IPR2020-00128 (’380 patent)
`
` IPR2020-00130 (’380 patent)
`
` IPR2020-00135 (’776 patent)
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`4.
`
`I am aware that when the Board instituted the IPR2020-00126 ’032
`
`petition it considered whether the limitation “interventional cardiology devices”
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`required that “all four enumerated devices (guidewires, balloon catheters, stents
`
`and stent catheters)” be insertable into the lumen of the claimed “device for use
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`with a standard guide catheter.” I.D., Paper 22, 10-13 (IPR2020-00126). This
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`limitation appears in independent claims 1 and 11. This limitation also appears in
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`claims 1 and 12 of the ’380 patent. (See I.D., Paper 22, 9-11) (IPR2020-00128).
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`5.
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`At institution, the Board determined that “interventional cardiology
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`devices” refers to “at least two types of the devices selected from the group that
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`includes but is not limited to guidewires, balloon catheters, stents, and stent
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`catheters.” I.D., Paper 22, 12 (IPR2020-00126). Additionally, it determined that
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`Medtronic demonstrated that the tubular portion of Itou’s catheter (2) has an inner
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`diameter through which both guidewire (6) and distal end protective catheter (5)
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`may be inserted. Id., 20.
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`5
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`Page 5
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`6.
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`I have reviewed Teleflex’s claim construction arguments, POR, 9-14
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`(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
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`cardiology devices,” or “at least four interventional cardiology devices.”
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`8.
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`Second, I disagree that “interventional cardiology devices” should be
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`construed to be limited to the four enumerated devices and to “any other device
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`that is delivered beyond the end of the device for use with a standard guide catheter
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`to a location in the coronary vasculature requiring treatment, to provide treatment
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`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.
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`6
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`Page 6
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`cardiology treatment device” interchangeably with “interventional cardiology
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`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,
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`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
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`catheters for providing backup support . . . .” Id., 2:45-49; and see, id., 1:7-8
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`(describing the invention relating generally to catheters used in interventional
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`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
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`device” as a much more general term to include devices that might be placed in the
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`coronary artery that are not actually treatment devices themselves, for example
`
`intracoronary imaging catheters. However, a POSITA would not even limit the
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`term “interventional cardiology device” in general only to the coronary arteries.
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`There is an entire subspecialty within interventional cardiology for non-coronary
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`7
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`Page 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
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`catheters used for imaging the heart, percutaneous femoral closure devices,
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`external vascular hemostasis devices, cardiac septal closure devices and cerebral
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`protection devices amongst many others.
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`11. Similarly, not even every intracoronary “interventional cardiology
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`device” is used to provide treatment. Devices in this category include intravascular
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`ultrasound catheter used for imaging the vessel, optical coherence tomography
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`catheter used for imaging the vessel and fractional flow reserve measurement
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`“pressure” wires. These devices are for diagnosis not treatment.
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`12. As illustrated below, an “interventional cardiology treatment device”
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`is but a subset of “interventional cardiology device(s).”
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`8
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`Page 8
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`13. Only a subset of the devices specifically identified in the specification
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`provide treatment. A guidewire does not provide treatment. It instead “provide[s] a
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`rail over which a series of therapeutic devices can be advanced.” Ex-1015, 95. Dr.
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`Graham’s testimony supports this. He acknowledges that a guidewire is used in
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`conjunction with a stent or balloon in order to treat an occlusion. Ex-1801, 89:2-
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`23.
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`IPRs:
`
`B.
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`“coaxial”
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`14.
`
`The opinions in this section generally relate to at least the following
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` IPR2020-00127 (ʼ032 Patent)
`
` IPR2020-00130 (ʼ380 Patent)
`
` IPR2020-00134 (’760 Patent)
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`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)).
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`Teleflex’s position is that Ressemann’s evacuation sheath includes an evacuation
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`head with a “multi-lumen tube,” and, as such, the lumen of the tubes are not
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`coaxial with the lumen of the guide catheter because neither is perfectly concentric
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`9
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`Page 9
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`with the lumen of the guide catheter. The images below are reproduced from
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`Teleflex’s brief and Mr. Keith’s Declaration.
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`IPR2020-00134, POR at 12; Ex-2138, 65-66.
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`16.
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`I disagree. A POSITA does not understand “coaxial” to refer to
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`perfect concentricity, so that the catheters share exactly the same center line. I have
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`reviewed the deposition testimony of Mr. Keith, who, now, agrees with this. Ex-
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`1764, 91:10-18; 94:11-19; Ex-1800, 23:19-24:1; Ex-1805, 107:19-109:6; 117:14-
`
`121:1.
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`17.
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`Besides reciting the coaxial arrangement articulated above, the
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`claims also recite that the guide catheter is positioned adjacent the coronary
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`ostium, and the guide extension catheter is inserted into the guide catheter to be
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`advanced through it and partially into the coronary artery. This configuration
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`allows for the guide extension to receive a stent or balloon catheter. Ex-1601, claim
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`25 (IPR2020-00134).
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`10
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`Page 10
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`18.
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`This is similar to the disclosure in the patent, which shows a guide
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`extension catheter inserted into a guide catheter, where the two are in line with the
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`coronary artery. Id., Fig. 8; 8:10-16.
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`19.
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`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
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`arrangement that is relatively close-fitting.” Ex-1764, 98:18-21. He was not,
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`however, able to specify how close fitting “relatively close-fitting” is. Id., 98:22-
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`99:12. He also testified that his opinion was that the tubes themselves have “radial
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`symmetry,” id., 101:20, but I see nothing in the patent claims or specification that
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`would require radial symmetry of the tubes themselves.
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`20. While the specification describes a 1 French relationship between
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`the guide catheter and guide extension catheter, not all of the claims of all of the
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`patents require this. Compare, e.g., ’760 patent (cl. 25, 13:6061) with ’380 patent
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`(cl. 1), ’032 patent (cl. 1). Thus, “coaxial” cannot require a 1 French differential
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`between the lumen of the guide extension catheter and the lumen of the guide
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`catheter. Dr. Graham, Teleflex’s cardiologist, agrees. Ex-1801, 37:22-28:2. So does
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`Mr. Keith, who testified that a 4-in-6 or a 5-in-7 relationship would still be coaxial.
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`Ex-1800, 23:19-24:1; Ex-1805, 119:4-121:1.
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`11
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`Page 11
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`Ex-1117.
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`21.
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`The import of these relationships is shown below. The larger the
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`differential between the OD of the extension catheter and the ID of the guide
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`catheter, the more room there is within the guide catheter for the extension catheter
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`to drift off-center, such that its axis is not perfectly concentric with that of the
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`guide catheter.
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`22.
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`The schematics below illustrate a 6 French guide catheter described
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`in the patent, which teaches that 6 French guide catheters have IDs of > 0.070
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`inches. Ex-1601, 3:42-44 (IPR2020-00134).
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`23.
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`On the left, the guide extension catheter is 5 French, which a
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`POSITA understands to correspond to 5 x (0.33) = 1.65 mm, which is 0.065 inches.
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`On the right, the guide extension catheter is 4 French, which a POSITA
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`understands is 4 x (0.33) = 1.32 mm = 0.052 inches.
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`12
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`Page 12
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`24.
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`Thus, “coaxial” must encompass both what the specification
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`discloses for a 5-in-6 relationship (an 0.005 inch annular gap), as well as the
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`admitted 4-in-6 relationship (an 0.18 inch annular gap). This is consistent with the
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`understanding of a POSITA. E.g. Ex-1840, 1 (describing using a 4 Fr angiographic
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`catheter within a 6 Fr guide catheter in a coaxial fashion); Ex-1841, 1 (describing a
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`coaxial double catheter technique using an 8 Fr guide catheter and a 5 Fr
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`diagnostic catheter).
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`25.
`
`I am also aware that one of the inventors, Mr. Root, testified
`
`
`
`
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`68:2 86:1-87:7; Ex-2015, 37:10-17. This is also consistent with the testimony of
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`Teleflex’s experts, as well as the understanding of a POSITA.
`
` Ex-1114, 66:22-
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`13
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`Page 13
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`26. Given the claims and specification of the patent, consistent with the
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`understanding of a POSITA, “coaxial” means the lumens are aligned. Specifically,
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`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
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`guiding … is a disputed, material issue of fact …. [that] is best resolved upon a full
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`trial record.” Id., 18. Having reviewed the testimony of Mr. Keith and Dr. Graham,
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`I still believe that claim 25 recites sufficient structure to overcome the means-plus-
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`function presumption.
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`14
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`Page 14
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`a.
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`The means-plus-function presumption is overcome because
`Claim 25 recites sufficient structure.
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`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
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`a means-plus-function limitation.
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`30.
`
`I understand that Mr. Keith and Dr. Graham believe that the means-
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`plus-function presumption for claim 25 is not overcome because the claim
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`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
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`interventional device can be received and be guided ‘deeper into the branch
`
`vessel.’” Ex-2138, ¶ 108 (IPR2020-00129); Ex-2145, ¶ 97 (IPR2020-00129). I
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`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
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`assembly (i.e., means for receiving and guiding) having a side opening where the
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`15
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`Page 15
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`lumen terminates prior to the distally-located portions (i.e., the sections found
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`distal to the side opening). In my opinion, there would be no reason to have a side
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`opening if the lumen terminated prior to the distally-located portion(s). I cannot
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`think of any function or reason to have a catheter assembly with a side opening that
`
`terminates into a lumenless portion.
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`32.
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`Further, by the time of the alleged invention, reinforcing catheters—
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`in particular, with metallic braiding or coiling—was common practice in the art.
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`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
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`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.
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`33.
`
`A POSITA would also expect the tip portion to have a lumen. This is
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`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
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`reinforced and tip portions have a lumen, and the means-plus-function presumption
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`is overcome.
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`16
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`Page 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
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`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
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`reinforced portion or tip portion in the specification of the ʼ380 patent. In other
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`words, if the specification of the ʼ380 patent is considered, it further supports my
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`conclusion that the reinforced and tip portion of claim 25 have a lumen.
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`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
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`corresponding structure for the means for receiving and guiding is an extension
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`catheter.
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`17
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`Page 17
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`36.
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`I understand that Mr. Keith and Dr. Graham agree that the
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`corresponding structure in the specification is a guide catheter, but they believe that
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`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
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`structure that allows interventional devices to be advanced alongside
`
`and into the lumen of the tubular portion, with the total length of the
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`device being longer than the guide catheter, and at least a distal part
`
`of the tubular portion is flexible.4
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`Ex-2138, ¶114 (IPR2020-00129) (emphasis added); Ex-2145, ¶¶99-100 (IPR2020-
`
`00129).
`
`37.
`
`I have been informed by counsel that when identifying the
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`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.”
`
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`3 I note that the specification never affirmatively states that the described guide
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`catheter is limited to a single lumen.
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`4 For ease of discussion, I refer to the extension catheter with Patent Owner’s
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`additional recitation of structure as “Extension Catheter + Structure.”
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`18
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`Page 18
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`
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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
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`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.
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`As a result, if the means-plus-function is not overcome, the
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`corresponding structure for the means for receiving and guiding is a guide catheter
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`that does not include Patent Owner’s additional recitation of structure.
`
`2.
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`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
`
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`5 As set forth above, I disagree with Patent Owner’s construction of coaxial.
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`§ II(B), supra. It is my opinion that Ressemann’s evacuation assembly is coaxial to
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`the guide catheter. See, e.g., § IV(A), infra.
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`19
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`Page 19
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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.
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`Itou-Based Grounds
`
`41. For the purpose of my analysis I have been asked to assume that Itou
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`is prior art to the Teleflex patents.
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`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
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`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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`20
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`Page 20
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`discloses a lumen through which all four, enumerated interventional cardiology
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`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
`
`21
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`Page 21
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`
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`
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`delivery balloon catheter), 25 (balloon-expandable Tsunami stent with 0.95 mm
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`(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)
`
`22
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`Page 22
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`
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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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`23
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`Page 23
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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.
`
`24
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`Page 24
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`
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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.