UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`Case IPR2020-01341
`U.S. Patent No. 8,142,413
`
`Case IPR2020-01342
`U.S. Patent No. 8,142,413
`
`Case IPR2020-01343
`U.S. Patent No. RE 46,116
`
`Case IPR2020-01344
`U.S. Patent No. RE 46,116
`
`
`
`SUPPLEMENTAL DECLARATION OF STEPHEN JON DAVID BRECKER,
`MD, FRCP, FESC, FACC
`
`
`
`
`
`
`
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`IPR2020-01343
`
`Medtronic Ex-1806
`Medtronic v. Teleflex
`Page 1 of 63
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`

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`
`
`I.
`II.
`
`III.
`
`D.
`
`E.
`
`Page
`Overview .......................................................................................................... 4
`Claim Construction .......................................................................................... 5
`A.
`“interventional cardiology device”........................................................ 5
`B.
`The claimed step of inserting an interventional cardiology
`device need not be performed only after the coaxial guide
`catheter is inserted into the guide catheter. ......................................... 10
`Itou-based grounds.........................................................................................13
`A.
`Types of interventional cardiology devices insertable through
`catheter (2) ........................................................................................... 13
`B. Distal end protective catheter (5) ........................................................ 16
`C. Advancing the interventional cardiology device . . . into contact
`with or past a lesion in the second artery ............................................ 17
`Itou discloses that protective catheter (5) is inserted through a
`guide catheter “alongside of the substantially rigid portion” of
`the coaxial guide catheter. ................................................................... 21
`Itou discloses “applying a force to . . . the coaxial guide catheter
`such that the distal portion of the coaxial guide catheter remains
`seated . . . in response to an opposing backward force exerted
`by the interventional cardiology device.” ........................................... 22
`Itou discloses that protective catheter (5) is extended through a
`“proximal side opening . . . while the proximal portion remains
`within the lumen of the guide catheter.” ............................................. 23
`It would have been obvious to insert an interventional
`cardiology device such as a stent or balloon through Itou’s
`suction catheter (2). ............................................................................. 24
`Itou and Ressemann collar 2141 ......................................................... 28
`Itou and Kataishi ................................................................................. 32
`
`F.
`
`G.
`
`H.
`I.
`
`Table of Contents
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`
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`IPR2020-01343
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`Medtronic Ex-1806
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`Page 2 of 63
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`V.
`
`2.
`
`3.
`
`C.
`
`IV. Kontos–based grounds ...................................................................................34
`A.
`Tube 16 of Kontos’s body 12 is not a narrow tube ............................. 34
`B. Kontos necessarily resists axial and shear forces that would
`otherwise tend to dislodge the guide catheter. .................................... 38
`The side opening claims are obvious. ................................................. 43
`1.
`Replacing Kontos’s proximal funnel with a side opening would
`maximize the usable “real estate” inside the catheter assembly.
` ...................................................................................................43
`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.” ...............................................................47
`After removing Kontos’s proximal funnel, Kontos’s support
`catheter 10 would remain coaxially aligned with the guide
`catheter. .....................................................................................51
`D. 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. ............................................................................................... 53
`E. My opinion remains unchanged: the claims that recite a two-
`inclined side opening are obvious. ...................................................... 55
`1.
`Kontos + Ressemann and Kontos + Ressemann + Takahashi ..55
`2.
`Kontos + Ressemann + Takahashi + Kataishi ..........................57
`Teleflex’s evidence regarding secondary considerations does not alter my
`opinion that the challenged claims are obvious. ............................................59
`
`
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`IPR2020-01343
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`Medtronic Ex-1806
`Medtronic v. Teleflex
`Page 3 of 63
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`
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`I.
`
`Overview
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`1.
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinions concerning U.S. Patent Nos. 8,142,413 and RE46,116 (the
`
`“Teleflex Patents”) in IPR2020-01341, IPR2020-01342, IPR2020-01343, and
`
`IPR2020-01344.1
`
`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 in these IPRs 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.
`
`3.
`
`I have reviewed additional material in conjunction with my analysis
`
`set forth herein. This includes the Final Written Decisions in IPRs on related
`
`Teleflex patents: IPR2020-00126, IPR2020-00127, IPR2020-00128, IPR2020-
`
`00129, IPR2020-00130, IPR2020-00132, IPR2020-00134, IPR2020-00135,
`
`IPR2020-00136, IPR2020-00137 and IPR2020-00138 (“Related IPRs”). A list of
`
`
`1 Citations to exhibits refer to exhibits filed in IPR2020-01341, unless noted
`
`otherwise. I understand that most of Teleflex’s and Medtronic’s exhibits are
`
`numbered consistently across all four IPRs.
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`
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`these materials includes everything cited in this declaration, and the materials
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`disclosed in my original declarations.
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`II. Claim Construction
`“interventional cardiology device”
`A.
`4.
`The opinion in this section generally relates to at least IPR2020-01341
`
`and IPR2020-01342.
`
`5.
`
`I am aware that when the Board instituted the IPR2020-01341 petition
`
`it determined that the limitation “interventional cardiology device” 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.” IPR2020-
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`001341, Paper 11 (“I.D.”) at 16. This limitation appears in independent claim 1 of
`
`the ’413 patent.
`
`6.
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`At institution, the Board additionally determined that the claims do
`
`not require that more than one of guidewires, stents, stent catheters, and balloon
`
`catheters be simultaneously insertable into and through the lumen of the claimed
`
`coaxial guide catheter. Id. Additionally, it determined that Medtronic demonstrated
`
`where Itou discloses every limitation of claim 1. Id. at 24.
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`7.
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`I have reviewed Teleflex’s claim construction arguments, IPR2020-
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`001341, Paper 23 (“POR”) at 14-17 (citing Ex-2138 (Declaration of Peter Keith)
`
`and Ex-2145 (Declaration of Doctor John J. Graham)),2 and I disagree.
`
`8.
`
`First, to the extent that Teleflex appears to argue this, I disagree that
`
`the term requires that all “four standard ICDs enumerated” in the specification be
`
`insertable. Id. at 14. 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.” Ex-1001,
`
`claim 1.
`
`9.
`
`Second, I disagree that “interventional cardiology device” should be
`
`construed to be limited to the four enumerated devices and to “any other device
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`delivered beyond the end of the device for use with a standard guide catheter to a
`
`location in the vasculature requiring treatment, to provide treatment to that
`
`location.”3 POR at 14.
`
`
`2 Where I cite to a POR in this Declaration, I have also reviewed the material cited
`
`therein, including the opinions of Teleflex’s experts.
`
`3 For example, it is my opinion that the distal protection device described in Adams
`
`(IPR2020-01342, Ex-1035) is an interventional cardiology device.
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`10.
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`I understand Teleflex’s argument to be, in part, that the patent
`
`specification uses the terms “cardiac treatment device” and “interventional
`
`cardiology treatment device” interchangeably with “interventional cardiology
`
`device[s].” POR at 14-15. 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, 1:31-34. 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 . . . .” Ex-1001, 2:51-55; see also, id., 1:13-14
`
`(describing the invention relating generally to catheters used in interventional
`
`cardiology procedures).
`
`11.
`
`I understand 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
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`device” in general only to the coronary arteries. There is an entire subspecialty
`
`within interventional cardiology for non-coronary interventions. Examples of
`
`interventional cardiology devices that are not placed in 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.
`
`12. Similarly, not even every intracoronary “interventional cardiology
`
`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
`
`catheter used for imaging the vessel, and fractional flow reserve measurement
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`“pressure” wires. These devices are for diagnosis not treatment.
`
`13. As illustrated below, an “interventional cardiology treatment device”
`
`is but a subset of “interventional cardiology device(s).”
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`14. 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.
`
`15. As I have testified in Related IPRs, a guidewire does not treat a lesion,
`
`it is merely the mechanism by which a treatment device is delivered. IPR2020-
`
`00126, Ex-2238, 19:6-16, 20:7-8. Following insertion of a guidewire in a blocked
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`artery, there may be instances in which some blood flow is restored. In some
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`patients, there may also be improvement in ST segments on an ECG, but other
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`patients may deteriorate with partial reperfusion. Id., 21:17-22:20. This is
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`illustrative of why guidewires cannot be considered treatment devices, insofar as a
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`POSITA is aware that while a guidewire may be necessary for delivering a therapy,
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`it cannot and indeed is not, considered a treatment device.
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`16. Moreover, when the inventors of the Teleflex Patents desired to claim
`
`a “treatment” device, they did so explicitly. See Ex-1845,4 16:1-5 (reciting
`
`advancement of a “treatment catheter”); see also IPR2020-01341, Paper 26
`
`(proposing ’413 patent substitute claims 15-17 that recite a “treatment catheter”
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`instead of “an interventional cardiology device”). They did not do so in the
`
`originally issued ’413 patent.
`
`B.
`
`The claimed step of inserting an interventional cardiology device
`need not be performed only after the coaxial guide catheter is
`inserted into the guide catheter.
`17. Limitation 1.f of claim 1 of the ’413 patent recites “inserting the
`
`interventional cardiology device into and through the continuous lumen of the
`
`standard guide catheter alongside of the substantially rigid portion and advancing
`
`the interventional cardiology device through and beyond a lumen of the flexible tip
`
`portion into contact with or past a lesion in the second artery.” Ex-1001, 11:1-6.
`
`
`4 Reference to Ex-1845 here is with respect to IPR2020-01341 and IPR2020-01342
`
`only. Ex-1845 was previously filed as Ex-1001 in IPR2020-01343 and Ex-1401 in
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`IPR2020-01344.
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`18.
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`I have reviewed Teleflex’s claim construction arguments, IPR2020-
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`001341, POR at 9-14, and I disagree.
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`19. As I have testified, claim 1 does not mandate insertion of an
`
`interventional cardiology device after insertion of a coaxial guide catheter.
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`Ex-2245, 82:7-83:3. Premounted or preformed devices may be advanced within a
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`catheter so long as the whole delivery system is de-aired, which guards against the
`
`danger of introducing an air embolism. Id., 94:19-23; see also Ex-1846, 39:7-14,
`
`44:5-14, 46:8-23, 48:21-49:14, 49:23-50:25; Ex-1797, 23:24-26:3.
`
`20.
`
`I am aware of other Teleflex claims in which the inventors were
`
`specific that an interventional cardiology device, such as a treatment catheter, is
`
`inserted into a guide extension catheter only after the guide extension catheter had
`
`already been advanced into the guide catheter. See e.g., Ex-1845, 16:1-5 (reciting
`
`advancement of a treatment catheter through a guide catheter and a guide extension
`
`catheter, and into a coronary artery, while the distal end of the guide extension
`
`catheter is positioned beyond the distal end of the guide catheter). Similar language
`
`is not found in the claims of the ’413 patent.
`
`21. Additional support for the fact that claim 1 does not require sequential
`
`insertion of a guide extension catheter (coaxial guide catheter) and interventional
`
`cardiology device comes from dependent claims 10 and 11:
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`10. The method of claim 9, further comprising extending the
`interventional cardiology device through the proximal side opening;
`advancing the interventional cardiology device through structure
`defining a full circumference portion; and advancing the interventional
`cardiology device through structure defining a partially cylindrical
`portion.
`11. The method of claim 9, further comprising extending the
`interventional cardiology device through a flexible cylindrical distal tip
`portion and a flexible cylindrical reinforced portion of the tubular
`structure proximal to the flexible distal tip portion.
`
`22.
`
`If the claims of the ’413 patent required that each step in each claim
`
`be performed sequentially, then claim 10 makes no sense. An interventional
`
`cardiology device cannot be advanced through a full circumference portion of a
`
`coaxial guide catheter’s side opening before it is advanced through a partially
`
`cylindrical portion. And that is because an interventional cardiology device is
`
`advanced through the side opening in a proximal to distal direction, and the
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`opening’s full circumference portion is more distal than its partially cylindrical
`
`portion. Ex-1001, Figs. 4, 12-16. In other words, an interventional cardiology
`
`device will first pass through the partially cylindrical portion before it reaches the
`
`full circumference portion. This sequence is the opposite of what is recited in claim
`
`10. This strongly suggests that the claim steps need not be performed in the
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`specific order in which they appear in the claims.
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`23. Similarly, for claim 11, an interventional cardiology device will first
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`advance through a cylindrical reinforced portion before it reaches the flexible
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`cylindrical distal tip portion. Ex-1001, Fig. 1 (depicting reinforced portion 18 and
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`tip portion 16).
`
`III.
`
`Itou-based grounds
`I have been asked to assume that Itou is prior art to the claims of the
`24.
`
`Teleflex Patents.
`
`25. As I discuss below, my opinion that the claims of the ’413 and ’116
`
`patents are invalid remains unchanged.
`
`A. Types of interventional cardiology devices insertable through
`catheter (2)
`26. Assuming that the claims of the ’413 patent are construed to require
`
`that two interventional cardiology devices must be insertable through the claimed
`
`lumen, Itou satisfies this limitation. Ex-1005, ¶ 221.
`
`27. 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, POR at 45, (and I disagree for the reasons discussed herein), Itou
`
`nonetheless inherently discloses a lumen through which all four, enumerated
`
`interventional cardiology devices (guidewires, balloon catheters, stents and stent
`
`catheters) are insertable.
`
`28.
`
`Itou teaches that guidewire (6) is insertable through the lumen of
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`catheter (2). Ex-1007, Fig. 5, 4:64-65, 5:11-20. Guidewires were known to range in
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`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.
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`29. 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, 4:48-64; Ex-1833, 1.
`
`30. There were also a variety of stents with crossing profiles that were
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`small enough to be advanced through a lumen of 0.046 inches (1.16 mm) that I
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`discuss below. Necessarily, each of the stents that are discussed were advanced into
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`the coronary vasculature on a “stent catheter.”
`
`31. 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.
`
`32. The 4th edition of the Handbook of Coronary Stents (Ex-1802)
`
`disclosed the following: balloon-expandable Genic® stent with less than 0.9 mm
`
`(0.035 inch) profile, id. at 4, 7; balloon-mounted Lunar stent with 0.0382 inch
`
`profile, id. at 15-16; Spiral Force stent with 0.039 to 0.042 inch profile and
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`“Runner” stent delivery balloon catheter, id. at 21; and balloon-expandable
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`Tsunami stent with 0.95 mm (0.038 inch) profile, id. at 25.
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`33. Similarly, US Pat. No. 6,726,714 taught a stent crimped against a
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`balloon with a “relatively small loaded diameter having an OD of 0.44 inches.” Ex-
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`1803, 4:54-56. And an article by Colombo described several balloon-expandable
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`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.
`
`34.
`
`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)
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`(3.48 Fr). I disagree, however, that the lumen of catheter (2) has an effective size
`
`of 0.046 inches.
`
`35. 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, ¶¶ 173-174.
`
`36. This calculation does not make sense to a practicing interventional
`
`cardiologist. It assumes, first, that catheter (2) is entirely rigid, such that wire (25)
`
`cannot be bent away from the angled proximal opening of the tubular portion of
`
`catheter (2).
`
`37.
`
`Itou explicitly teaches this is not the case, as it discloses that catheter
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`(2)—and in particular its distal tubular portion—must be navigated into the
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`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
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`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.
`
`38. Additionally, Itou teaches that wire (25) is flattened at its distal most
`
`end, “crushed into a 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.
`
`B. Distal end protective catheter (5)
`Itou discloses distal end protective catheter (5), which is an
`39.
`
`interventional cardiology device. Ex-1005, ¶¶ 221-225.
`
`40.
`
`Itou describes inserting catheter (5) into catheter (2), and then
`
`advancing the two catheters, together, into guiding catheter (1) and into the
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`vasculature. Ex-1007, 5:43-46, 7:13-18. Once the assembly was positioned in the
`
`desired location, and as taught by Itou, catheter (5) would be withdrawn before
`
`catheter (2) would be used for suction. Catheter (2) could also be used to deliver a
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`different interventional cardiology device.
`
`41. 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
`
`reintroduced 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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`42. Sequential delivery would be an obvious alternative to preassembly,
`
`albeit not routine.
`
` Ex-1851, 165:3-25.
`
`
`
`C.
`
`43.
`
`Advancing the interventional cardiology device . . . into contact
`with or past a lesion in the second artery
`I understand that Teleflex argues that Itou does not disclose an
`
`interventional cardiology device that comes “into contact with” a “lesion.” POR at
`
`38-40. I disagree. Ex-1005, ¶¶ 221-225.
`
`44. Dr. Graham states that the target location for Itou’s suction catheter is
`
`“just on the proximal side of the thrombus.” Ex-2145, ¶ 119. He relies on teachings
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`in Itou, however, which do not say this. Id., (citing Ex-1007, 7:1-27); see also Ex-
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`2138, ¶ 156 (citing to the same).
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`45. As an initial matter, Itou describes that the guiding catheter is
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`positioned “proximal” to the target location, such as within the coronary ostium.
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`Ex-1007, 1:66-2:5. This is illustrated in Itou’s Fig. 6, below. Guiding catheter (1) is
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`positioned in the coronary ostium, proximal of target location (80).
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`Ex-1007, Fig. 6 (color added).
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`46.
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`Itou explains that the “target location” is located deep in the coronary
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`artery. Id., Abstract, 1:6-9, 5:35-38. Such a location is depicted in Figure 6 at (80).
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`47.
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`Itou additionally teaches that suction catheter (2) and distal end
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`protective catheter (5) are inserted together to the target location. Ex-1007, 7:13-
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`18; see also id., 5:43-46. The distal tip of catheter (2) is in contact with the target
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`location (80). Furthermore, Itou explains that the distal tip of catheter (5) is
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`designed to extend distally of the distal opening of catheter (2). Id., Fig. 5, 4:48-55,
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`Table 1 (describing catheter (2) as having a length of 1250 mm and catheter (5) as
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`having a length of 1320 mm). Mr. Keith admits this. Ex-2138, ¶ 172. As Itou
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`explains, the tubular portion of catheter (5) should range from 20-50 mm in length,
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`so as to adequately provide a protective function. Ex-1007, 6:36-41. Necessarily,
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`the tip of protective catheter (5) comes into contact with the target location.
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`48. That the distal ends of both suction catheter (2) and catheter (5) come
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`into contact with the foreign matter at the target location is not surprising. Dr.
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`Graham explains that suction catheters are typically designed to extend beyond a
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`thrombus so as to be able to aspirate it in its entirety. Ex-2145, ¶ 120; see also
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`Ex-1025 (Kataishi). This is consistent with Itou’s teaching that the distal tips of
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`catheter (2) and catheter (5) are soft and flexible tip, so as to reduce damage to the
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`blood vessel. Ex-1007, 3:22-28, 4:48-55. Itou contemplates that the distal ends of
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`catheter (2) and catheter (5) come into contact with the coronary artery walls at the
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`target location (80).
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`49.
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`Itou is explicit that the target location is one at which there is foreign
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`matter, “such as a thrombus or an embolus” that cause constriction of the blood
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`vessel. Id., Abstract, 1:6-9, 5:35-38. This is also depicted in Figure 6 at (80).
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`50. Finally, Itou explains that, after catheter (2) is withdrawn, then
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`catheter (2) is manipulated (“rotated, pushed or pulled”) until its distal tip is “in
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`front of a thrombus,” as seen in Figure 6. Ex-1007, 7:20-23. This disclosure does
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`not alter my opinion. By the time catheter (2) is manipulated in this fashion, its
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`distal end—and the distal tip of catheter (5) —have necessarily already come into
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`contact with the foreign matter at the target location.
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`51. Mr. Keith states that “lesion” and “thrombus” are not synonymous.
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`Ex-2138, ¶ 155. He is partially correct but misunderstands the relationship of one
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`to the other. They are not synonymous, but the overwhelming majority of inter-
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`coronary thrombus form on pre-existing atherosclerotic lesion.
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`52. As taught in Baim, coronary lesions may be characterized according
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`to their complexity.
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`Ex-1015, 127.
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`53. While minimally complex lesions do not have thrombus, more
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`complex lesions do. Stated differently, from the disclosure of Itou, a POSITA
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`would understand there was a lesion at target location 80 in the coronary artery.
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`Ex-1007, Fig. 6.
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`D.
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`Itou discloses that protective catheter (5) is inserted through a
`guide catheter “alongside of the substantially rigid portion” of the
`coaxial guide catheter.
`54. As I discuss above, claim 1 does not require sequential insertion of a
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`coaxial guide catheter into a guide catheter, followed by insertion of an
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`interventional cardiology device.
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`55. When pre-assembled, wire-like portion (55) of catheter (5) is
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`“alongside of the substantially rigid portion” of suction catheter (2). See Ex-1005,
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`¶¶ 221-225.
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`56. Under Mapping-1, the “substantially rigid portion” of catheter (2)
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`includes both wire-like portion (25) and proximal tip 23. Under Mapping-2, the
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`“substantially rigid portion” of catheter (2) is wire-like portion (25).
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`57.
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`Itou additionally teaches that—following preassembly—suction
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`catheter (2) and protective catheter (5) are inserted into and through the continuous
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`lumen of the standard guide catheter. Ex-1007, 5:43-46.
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`E.
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`58.
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`Itou discloses “applying a force to . . . the coaxial guide catheter
`such that the distal portion of the coaxial guide catheter remains
`seated . . . in response to an opposing backward force exerted by
`the interventional cardiology device.”
`I understand that Teleflex argues that Itou does not disclose claim 2.
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`POR at 40-41. I disagree. Ex-1005, ¶ 226 (citing id., ¶¶ 160-173).
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`59.
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`Itou explicitly discloses applying force to the proximal end of suction
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`catheter (2). Ex-1007, 5:43-46.
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`60.
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`Itou also teaches that the distal end of catheter (2) is advanced to a
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`target location in the coronary artery and is maintained at that location, even as the
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`distal end of protective catheter (5) extends further into the coronary artery. Ex-
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`1007, Figs. 5, 6, 4:48-55, 5:35-51, 6:36-41, Table 1 (describing catheter (2) as
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`having a length of 1250 mm and catheter (5) as having a length of 1320 mm). The
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`extension of distal end protective catheter (5) beyond the distal tip of catheter (2)
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`necessarily generates an opposing backwards force. Ex-1807, ¶¶ 47-51.
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`61.
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`I have also opined that it would be obvious to use catheter (2) to
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`deliver a balloon catheter or stent. In the event that a balloon catheter or stent are
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`delivered through suction catheter (2), this limitation is also necessarily met.
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`F.
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`62.
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`Itou discloses that protective catheter (5) is extended through a
`“proximal side opening . . . while the proximal portion remains
`within the lumen of the guide catheter.”
`Itou discloses this limitation. Ex-1005, ¶¶ 231-235.
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`63. Contrary to Patent Owner’s arguments, POR at 41-42—and similar to
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`claim 1—claim 9 does not require that the proximal portion of the coaxial guide
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`catheter already be within the guide catheter before an interventional cardiology
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`device is extended through the coaxial guide catheter’s side opening.
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`64.
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`Itou teaches that an assembly of catheter (5) and catheter (2) be
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`advanced into the coronary artery, and that the proximal end of catheter (2)’s
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`tubular portion remain within the guide catheter. Ex-1007, 5:35-46, 7:13-18.
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`65. Prior to its withdrawal, catheter (5) is extended through the proximal
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`side opening of catheter (2)’s tubular structure, and extends for a distance along the
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`longitudinal axis of the proximal portion of the tubular structure. Id., Fig. 5, 4:48-
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`52.
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`G.
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`66.
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`It would have been obvious to insert an interventional cardiology
`device such as a stent or balloon through Itou’s suction catheter
`(2).
`I understand that Teleflex disputes that a POSITA would first insert
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`suction catheter (2) into a guide catheter, and then separately and sequentially
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`insert an interventional cardiology device through the suction catheter. POR at 43-
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`51. I also understand that Teleflex disputes that a POSITA’s use of Itou’s catheter
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`(2) would be informed by the teachings of Ress