UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioner,
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`Case No.: IPR2020-00126
`Case No.: IPR2020-00127
`U.S. Patent No: 8,048,032
`
`DECLARATION OF STEPHEN JON DAVID BRECKER,
`MD, FRCP, FESC, FACC SUBMITTED IN SUPPORT OF PETITIONER’S
`OPPOSITION TO PATENT OWNER’S MOTION TO AMEND
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`Table of Contents
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`Page
`
`I.
`II.
`III.
`IV.
`
`INTRODUCTION ........................................................................................... 1
`LEGAL STANDARD ...................................................................................... 1
`PERSON OF ORDINARY SKILL IN THE ART ........................................... 3
`SUBSTITUTE CLAIMS 23-25 OF THE ’032 PATENT ARE OBVIOUS IN
`VIEW OF ITOU .............................................................................................. 4
`A.
`Itou in View of Ressemann Renders Claims 23-25 Obvious ................ 4
`B.
`Itou in View of Kataishi Renders Claims 23-25 Obvious ...................44
`SUBSTITUTE CLAIMS 23-25 OF THE ’032 PATENT ARE OBVIOUS IN
`VIEW OF KONTOS, RESSEMANN, TAKAHASHI AND/OR THE
`KNOWLEDGE OF A POSITA. ....................................................................60
`VI. SUBSTITUTE CLAIMS 23 AND 24 ARE OBVIOUS IN VIEW OF
`KONTOS, RESSEMANN, TAKAHASHI, KATAISHI, AND/OR THE
`KNOWLEDGE OF A POSITA. ....................................................................99
`VII. CONCLUSION ............................................................................................101
`
`V.
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`ii
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`I.
`
`Introduction
`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 on the subject matter recited in U.S. Patent No. 8,048,032.
`
`2.
`
`I make this declaration based on personal knowledge. I am over the
`
`age of 21 and am otherwise competent to make this declaration.
`
`3.
`
`I have submitted other declarations in connection with these petitions
`
`and do not repeat the content of those declarations herein.
`
`4.
`
`I understand that Teleflex proposes to substitute the claims below for
`
`claims of the ’032 patent in IPR2020-00126 and IPR2020-00127. It is my opinion
`
`that certain prior art references teach or suggest all of the features recited in
`
`substitute claim 23 (previously claim 1), substitute claim 24 (previously claim 11)
`
`and substitute claim 25 (previously claim 16). It is my opinion that substitute
`
`claims 23-25 are invalid as obvious.
`
`5.
`
`In the charts herein, Teleflex’s proposed amendments are underlined,
`
`while deleted language is in [brackets].
`
`II. Legal Standard
`
`6.
`
`I understand that under U.S. Patent Law, 35 U.S.C. § 103, a claim is
`
`invalid as obvious if the differences sought to be patented and the prior art are such
`
`that the subject matter as a whole would have been obvious at the time the
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`1
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`invention was made to a person having ordinary skill in the art to which said
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`subject matter pertains.
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`7.
`
`I am informed that an obviousness analysis requires an assessment of
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`the scope and content of the prior art, the differences between the art and the
`
`claims at issue, and the level of ordinary skill in the art. I am told that it is against
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`this backdrop that obviousness is assessed.
`
`8.
`
`I am also informed that there may be objective indicia of
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`non-obviousness, or secondary considerations that must be considered when
`
`present. I understand that secondary considerations may be used to rebut a prima
`
`facie showing of obviousness.1
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`9.
`
`I understand that factors that may be considered in determining the
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`level of ordinary skill in the art include (a) the educational level of the inventor; (b)
`
`the type of problem encountered in the art; (c) prior art solutions to those
`
`problems; (d) the rapidity with which inventions are made; (e) sophistication of the
`
`technology; and (f) the educational level of those working in the field.
`
`
`1 To date, I am unaware of any objective indicia of non-obviousness that have been
`
`raised in conjunction with Patent Owner’s Motion to Amend. To the extent that the
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`Patent Owner offers any in connection with these proceedings, I will respond to
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`them as appropriate.
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`2
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`10.
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`I am informed that a POSITA is a hypothetical person who is
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`presumed to be aware of all the pertinent prior art. I am also informed that an
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`obviousness analysis may take account of the inferences and creative steps that a
`
`person of ordinary skill in the art would employ.
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`III. Person of Ordinary Skill in the Art
`
`11. For this patent, a person of ordinary skill in the art (“POSITA”) at the
`
`time of the alleged invention would have had (a) a medical degree, (b) completed a
`
`coronary intervention training program, and (c) experience working as an
`
`interventional cardiologist. Alternatively, a POSITA would have had (a) an
`
`undergraduate degree in engineering, such as mechanical or biomedical
`
`engineering; and (b) three years of experience designing medical devices,
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`including catheters or catheter-deployable devices. Ex. 1042, ¶ 18-19 (IPR2020-
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`00126). Extensive experience and technical training might substitute for education,
`
`and advanced degrees might substitute for experience. Additionally, a POSITA
`
`with a medical degree may have access to a POSITA with an engineering degree,
`
`and one with an engineering degree might have access to one with a medical
`
`degree.
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`3
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`IV. Substitute claims 23-25 of the ’032 Patent are Obvious in View of Itou
`
`A.
`
`Itou in View of Ressemann Renders Claims 23-25 Obvious
`
`12. Claim 23
`
`Claim Language
`
`Evidence & Corresponding Disclosure
`
`[23.pre.I] “A
`device for use with
`a standard 6 French
`guide catheter,”
`
`Itou discloses this limitation.
`
`For example, it explains:
`
`
`Ex. 1007, 2:27-41.
`
`It also teaches:
`
`
`Id., 5:29-46.
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`4
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`13.
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`Itou discloses a combination of a guiding catheter 1 and suction
`
`catheter 2.
`
`Ex. 1007, Figs. 1A-B.
`
`14. Suction catheter 2 is insertable into guiding catheter 1, which Itou
`
`teaches is a standard 6 French guiding catheter. Ex. 1007, 6:47-50.
`
`
`
`Ex. 1007, Fig. 5.
`
`5
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`15.
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`Itou also discloses that the combination is used for delivering a distal
`
`end protective catheter 5 and a guide wire 6 to the location of an occlusion. Id.,
`
`1:66-2:11; see id., Abstract, 5:32-38, 5:43-46, 7:1-23, 7:35-43.
`
`Ex. 1007, Fig 6.
`
`16.
`
`23.pre.II
`
`
`
`Claim Language
`
`Evidence & Corresponding Disclosure
`
`[23.pre.II] “the
`standard guide
`catheter having a
`continuous lumen
`extending for a
`predefined length
`from a proximal
`end at a hemostatic
`valve to a distal
`end adapted to be
`placed in the
`
`Itou discloses this limitation.
`
`Guiding catheter (1) has distal end 12 and body portion
`(11), which terminates at connector (13). Ex. 1007,
`Fig. 1A, 3:29-36.
`
`
`
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`6
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`Claim Language
`
`Evidence & Corresponding Disclosure
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`branch artery,”
`
`
`
`Ex. 1007. Fig. 5 (color added).
`
`The guiding catheter necessarily has a continuous lumen.
`Otherwise the suction catheter, distal end protective
`catheter and guide wire could not be inserted into the
`proximal end of the guiding catheter and be extended
`through its distal end, as shown in Figure 5.
`
`Thus, guiding catheter 1 must have a continuous “cavity,”
`consistent with the district court construction of “lumen”
`meaning the “cavity of a tube.” Ex. 1005, ¶ 141.
`
`Additionally, because a valve is connected to the proximal
`end of guiding catheter (1), see infra, to prevent a leak, the
`walls of the guiding catheter (1) must be continuous along
`their length.
`
`Itou explains that connector (13) is coupled to Y-shaped
`connector (3), which includes main connector portion (31).
`Ex. 1007, 5:11-22. Connector (31) includes a valve, which
`can close a bore in connector (31) and “selectively clamp
`and fix the guide wire 6, the wire-like portion 25 or 55 to
`prevent leakage of the blood.” Id., 5:20-23.
`
`Itou’s teachings disclose to a POSITA that the proximal end
`of guiding catheter (1) extends from a hemostatic valve.
`
`This is consistent with the ’032 patent’s admission that the
`“guide catheter . . . can be delivered through commonly
`existing hemostatic valves used with guide catheters while
`still allowing injections through the existing Y adapter.”
`Ex. 1001, 2:65-3:1. Similarly, Patent Owner’s expert in the
`co-pending litigation explains that a hemostatic valve is
`sometimes called a Y-connector. Ex. 1082, ¶ 18.
`
`Itou teaches that guiding catheter (1) “preferably has
`dimensions equal to those of a guiding catheter used in
`ordinary catheter operation.” Ex. 1007, 5:65-67.
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`Claim Language
`
`Evidence & Corresponding Disclosure
`
`
`Distal end (12) of guiding catheter (1) is “to be inserted to a
`location on a proximal side of a target location,” which
`may be deep in a coronary artery. Ex. 1007, 1:66-2:4,
`5:32-34, 7:7-10, Fig. 6.
`
`Itou explicitly discloses that the guide catheter may be
`placed in “an ostium portion of a coronary artery.” Id.,
`2:4-5. This is consistent with the ’032 patent’s teaching that
`a guide catheter is “typically seated into the opening or
`ostium of the coronary artery.” Ex. 1001, 1:32-34.
`
`Thus, Itou teaches placement of guiding catheter (1) that
`meets the construction of “placed in a branch artery,”
`which includes “placement in the ostium of a coronary
`artery.” Ex. 1005, ¶ 147.
`
`
`
`
`
`
`
`Ex. 1015, 548.
`
`
`Id., 549.
`
`
`17.
`
`23.pre.III
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`Claim Language
`
`Evidence & Corresponding Disclosure
`
`[23.pre.III] “the
`continuous lumen
`of the guide
`catheter having a
`circular cross-
`sectional inner
`diameter sized such
`that interventional
`cardiology devices
`are insertable into
`and through the
`lumen to the
`branch artery, the
`device comprising,
`in a distal to
`proximal
`direction:”
`
`18.
`
`23.a
`
`Itou discloses.
`
`
`
`Ex. 1007, 4:55-67.
`
`The guiding catheter necessarily has a “circular cross-
`sectional inner diameter.” Table 1 reports an “inner
`diameter of 1.8 mm.”
`
`Both the distal end protective catheter and the guidewire
`are sized to be insertable through the lumen of the guiding
`catheter. Ex. 1007, 4:61-63, 3:59-63, 4:43-52, Fig. 5.
`
`Evidence & Corresponding Disclosure
`Itou discloses
`
`Suction catheter (2) has a distal “flexible tip portion,”2
`which consists of tubular portion (21) and tip (22).
`
`Claim Language
`[23.a] “a flexible
`tip portion defining
`a tubular structure
`having a circular
`cross-section and a
`
`2 The “flexible tip portion” in claim 23, which corresponds to tubular portion (21)
`
`and tip (22) alone, corresponds to the “flexible tip portion” in claim 24, which
`
`additionally claims a “reinforced portion proximal to the flexible tip portion.”
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`Evidence & Corresponding Disclosure
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`
`
`
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`Ex. 1007, Figs. 1B (top), 3 (bottom) (color added).
`
`Flexible tip portion [21, 22] is part of catheter (2)’s tubular
`portion (24).
`
`As set forth in Table 1, tubular portion (24) (and therefore
`flexible tip portion [21, 22]) has an inner diameter of 1.5
`mm. Ex. 1007, 7:58-60. Cross sections are circular. See id.,
`Fig. 7B.
`
` A
`
` diameter of 1.5 mm is 0.059 inches, which is “at least
`0.056 inches.”
`
`Tubular portion (24) “is shorter than the guiding catheter.”
`Ex. 1007, 2:23-25. Flexible tip [21, 22] is necessarily also
`shorter.
`
`Itou also teaches that the tubular structure defined by
`flexible tip [21, 22] has a cross-sectional outer diameter
`sized to be insertable through the cross sectional inner
`diameter of guiding catheter 1, which Itou also teaches is 6
`French. Ex. 1007, 6: 47-50.
`
`
`10
`
`
`
`Claim Language
`length that is
`shorter than the
`predefined length
`of the continuous
`lumen of the
`standard 6 French
`guide catheter, the
`tubular structure
`having a cross-
`sectional outer
`diameter sized to
`be insertable
`through the cross-
`sectional inner
`diameter of the
`continuous lumen
`of the guide
`catheter and
`defining a coaxial
`lumen having a
`cross-sectional
`inner diameter of at
`least 0.056 inches
`through which
`interventional
`cardiology devices
`are insertable; and”
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`Evidence & Corresponding Disclosure
`Tubular portion (24) (and therefore flexible tip portion [21,
`22]) has an outer diameter of 1.72 mm.
`
`This is sized to be insertable through the cross-sectional
`inner diameter of the continuous lumen of the guiding
`catheter, which is 1.8 mm. Id., Table 1, 1:59-65. Tubular
`portion (24) (and therefore flexible tip portion [21, 22]) is
`also coaxial to the guiding catheter. Id., Figs. 5, 6.
`
`Protective catheter (5) is insertable through tubular portion
`(24). Id., Table 1, 4:48-52, 7:1-23, Fig. 5. Catheter 5 is
`necessarily also insertable through flexible tip portion [21,
`22].
`
`
`Evidence & Corresponding Disclosure
`Proximal to the Itou’s “flexible tip portion” discussed in
`23.a, Itou discloses a substantially rigid side opening with a
`first inclined region (red arrows below).
`
`
`
`
`
`
`Claim Language
`
`19.
`
`23.b
`
`Claim Language
`[23.b] “a
`substantially rigid
`side opening that
`includes a first
`inclined region, a
`second inclined
`region, and a non-
`inclined concave
`track between the
`first and second
`inclined regions;
`and”
`
`
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`Claim Language
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`Evidence & Corresponding Disclosure
`Ex. 1007, Figs. 1B (top), 3 (bottom) (color and annotation
`added).
`
`Itou in view of Ressemann renders 23.b obvious.
`
`
`20. A POSITA would look to Ressemann’s collar 2141 to modify Itou’s
`
`side opening.
`
`21. Both references disclose devices that address the same problem in the
`
`same way—treating coronary vessel occlusions by using an aspiration catheter, the
`
`distal end of which is extended past a guide catheter’s distal end, into a coronary
`
`artery. Ex. 1007, Abstract, 1:13-16, 2:2-5, 2:29-38, 3:59-61, 5:32-34, 7:10, Figs.
`
`1A-B, 5, 6; Ex. 1008, Abstract, 6:18-24, 12:9-12, 12:19-30, Figs. 6A-B.
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`22. The evacuation head of Ressemann has a proximal opening 140a that
`
`extends for a distance from (a) to (b) along the longitudinal axis of the evacuation
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`sheath. Ex. 1008, Figs. 1A, 11A. This forms a “side opening.”
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`Ex. 1008, Fig. 1A (color and annotations added).
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`23. The head’s diameter is large enough to “allow the passage of most
`
`therapeutic devices such as angioplasty catheters, stent delivery catheters,
`
`atherectomy catheters . . . .” Ex. 1008, 10:17-20; 12:3-8. Ressemann further
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`teaches that the evacuation sheath should be advanced through a guide catheter
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`until the head’s (a) distal end is distal to the distal end of the guide catheter; and (b)
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`proximal end remains in the guide catheter. Id., 12:19-26, Fig. 6B (below, left).
`
`
`Id., Figs. 6B, 6E.
`
`
`24. Ressemann also explains that a stent delivery system should be
`
`advanced through the evacuation sheath and then across a stenotic lesion. Id.,
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`13:15-16, 13:57-60, Fig. 6E (above, right); and see Fig. 6F, depicting balloon
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`inflation of stent 194 (below).
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`25. A POSITA would be motivated to combine the teachings of Itou and
`
`Ressemann for at least the reasons discussed below.
`
`26. Aside from Ressemann’s explicit teaching to use an aspiration
`
`catheter to deliver a balloon or stent, this was taught by others, too.
`
`27. Bagaoisan explained that an aspiration catheter is “preferably sized so
`
`as to allow the slidable insertion of a therapy catheter through the main aspiration
`
`lumen of the aspiration catheter.” Ex. 1019, 3:4-5; 3:34-36. Bagaoisan additionally
`
`teaches that
`
`[T]he aspiration catheter can be configured such that the therapy
`
`catheter can be inserted through the lumen of the aspiration catheter.
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`The lumen is made large enough to accommodate the desired therapy
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`catheter. This allows the aspiration catheter and the therapy catheter to
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`be delivered into the patient at the same time. When therapy is
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`complete, the therapy catheter is removed while the aspiration catheter
`
`remains in place. This eliminates the need to separately deliver the
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`aspiration catheter after removal of the therapy catheter, saving
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`valuable time. Alternatively, if the shaft of the therapy catheter is
`
`sufficiently small to allow aspiration around the catheter, the therapy
`
`catheter can remain in place during aspiration. This too saves valuable
`
`time by eliminating the need to remove the therapy catheter prior to
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`aspirating.
`
`Id., 12:16-30.
`
`28. Bagaoisan recognized what others working in the field knew too.
`
`Following coronary bypass surgery, there was the risk that the grafts themselves
`
`would become stenosed or occluded. Id., 2:1-10. And treating these grafts with
`
`balloon angioplasty came with the risk of embolization. Id., 2:12-27.
`
`29.
`
`In an article published in 2002, a distal embolic protection device was
`
`used during percutaneous intervention of saphenous vein aorto-coronary bypass
`
`grafts. Ex. 1028. The authors noted that “[b]y 7 to 10 years after bypass surgery,
`
`more than half of such grafts develop significant narrowing or occlusion.” Id.,
`
`1289.
`
`30. Figure 1 illustrates the use of a distal protection device.
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`Ex. 1028, Fig. 1.
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`31. The authors reported a “significant reduction in major adverse events
`
`compared with stenting over a conventional angioplasty guidewire.” Id., 1285.
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`Ex. 1028, Table 4.
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`32. The authors conclude that the study “makes clear the importance of
`
`distal atheroembolization and the benefit of devices that prevent it during catheter-
`
`based intervention in saphenous vein grafts and potentially in other territories (e.g.,
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`native coronary, carotid, renal arteries) where distal embolization causes
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`significant end-organ damage.” Id., 1290.
`
`33. The benefits of addressing the potential for embolization during a PCI
`
`procedure is not just limited to PCI procedures performed in grafts.
`
`34.
`
`In a study published in 2003, a distal embolic protection device was
`
`used during primary PCI procedures. Ex. 1029. The authors explained that:
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`Signs of microvascular hypoperfusion after successful primary
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`percutaneous coronary intervention (PCI) have been observed in up to
`
`80% of cases according to the marker used to assess effective
`
`reperfusion, such as angiographic myocardial blush, resolution of ST-
`
`segment elevation, or myocardial contrast echocardiography. This
`
`occurrence, named “no-reflow,” is associated with poorer functional
`
`recovery and adverse outcome. Distal embolization of thrombus/plaque
`
`components during primary PCI may play a crucial role in limiting
`
`effective myocardial reperfusion; thus, it can be hypothesized that
`
`mechanical prevention of distal embolization might prevent no-reflow
`
`during primary PCI.
`
`Ex. 1029, 171
`
`35.
`
`In their study, the authors used a device called the “FilterWire-EX
`
`(FW),” described as “a 0.014-inch guidewire that incorporates a nonoccluding
`
`polyurethane porous membrane filter (80-µm pores) in the shape of a windsock to
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`allow retention and removal of embolized particles.” Id.
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`36. The authors reported that “(1) the FW may be used during primary
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`PCI in selected cases with a high delivery success rate and without significant
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`complications; (2) multiple, distal embolization frequently occurs during primary
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`PCI; and (3) in this clinical setting, mechanical prevention of distal embolization
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`may improve myocardial reperfusion and recovery of LV function.” Id., 174. They
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`also noted that “[d]istal embolization during primary PCI has an effect on
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`reperfusion effectiveness and on prognosis, because it brings an increased risk of
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`death at 5 years of 44% compared with 9% in patients without embolization.” Id.
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`37. Thus, before the alleged invention of the ’032 patent, a POSITA was
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`aware that PCI procedures came with the risk of embolization, at least in part
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`because such procedures may break free fragments of friable plaque. Ex. 1015,
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`629. S/he was also aware of devices that could be used to alleviate that risk,
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`including distal embolic protection devices and suction/aspiration catheters. Ex.
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`1008; Ex. 1019; Ex. 1028; Ex. 1029; see Ex. 1015, 601, 627-31 (discussing
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`“systems designed to aspirate and remove thrombus from the body” as well as
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`distal embolic protection devices). Accordingly, a POSITA had the motivation to
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`use Itou’s suction catheter (2) to deliver a balloon or stent across a lesion, as
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`explicitly taught in Ressemann.
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`38. A POSITA would understand that, by using a suction catheter large
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`enough to deliver a therapy catheter, a PCI procedure could be performed without
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`needing to change out the catheter between suction and stenting operations. Ex.
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`1008, 14:29-34 (“ In some instances, once the particulate . . . has been removed,
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`additional contrast delivery to the blood vessel may indicate a need for more
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`therapeutic steps, e.g., further dilation of the stent with the balloon. In this case, it
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`is more convenient to have the balloon catheter already in position for any
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`subsequent use.”).
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`39. There was also a reasonable expectation of success, given what was
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`known in the art (as discussed above), and given the size of the tubular portion of
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`suction catheter (2) and the size of balloons and stents that were available.
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`40. The inner lumen of Resseman’s sheath is “approximately 0.061
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`inches,” allowing for the “passage of most therapeutic devices such as angioplasty
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`catheters [and] stent delivery catheters . . . .” Ex. 1008, 10:17-20. An inner
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`diameter of 0.061 inches corresponds to 1.54 mm (4.6 Fr).
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`41. Kontos teaches that PTCA catheters were insertable through support
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`catheters with an 0.045 inch inner lumen. Ex. 1009 4:46-50, 4:61-64. An inner
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`diameter of 0.045 inches corresponds to 1.1 mm (3.3 Fr).
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`42.
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`Indeed, successful angioplasty procedures had been performed
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`through 4 French angioplasty catheters. Ex. 1020, 22. This corresponds to
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`1.33 mm, or 0.052 inches.
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`43. Thus, prior art catheters with inner lumen diameters of 1.54, 1.1, and
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`1.33 mm had been successfully used for balloon angioplasty procedures.
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`44.
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`Itou teaches a suction catheter with an inner diameter toward the top
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`of the range discussed above, 1.5 mm. Ex. 1007, Table 1. This was large enough to
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`accommodate the insertion of a therapy catheter. An inner diameter of 1.5 mm
`
`corresponds to an inner diameter of 0.059 inches.
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`45. The structure of suction catheter (2) allowed it to be inserted into
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`guiding catheter (1), and—as taught by Ressemann—used to receive a balloon-
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`expandable stent.
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`46. Several such stents were available at the time of the purported
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`invention of the ’032 patent.
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`47. A Cordis stent, the Cypher™ Sirolimus-eluting coronary stent
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`(between 2.5-3.0 mm on an RX delivery system) required a catheter with an inner
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`diameter of > 0.056 in. (1.4 mm). Ex. 1022, 3.
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`48. The Medtronic Driver™ stent, on either an OTW or RX system,
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`required a catheter with an inner diameter of 0.056 inches (1.4 mm). Ex. 1023, 9.
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`49. A Boston Scientific stent, the TAXUS™ Express2™ Paclitaxel-eluting
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`stent, required a catheter with an inner diameter of > 0.058 in. (1.47 mm). Ex.
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`1024, 2.
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`50.
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`I am aware that when the Itou patent was being prosecuted, the
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`Examiner’s view was that it was appropriate to look to angioplasty art when
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`considering claims to a suction assembly.
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`51. The Examiner rejected Itou’s claims in view of a prior art angioplasty
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`balloon catheter, because the disclosed catheter could be used to suction
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`intravascular foreign matter. Ex. 1021, 3.
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`Claims 1 and 7-12 are rejected under 35 U.S.C. 102(b) as being anticipated by
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`Adams et al. (USPN5,385,562). Adams et al. discloses a quide catheter system for an
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`angioplasty balloon catheter.
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`Regarding claims 1 and 7-12, Adamsetal. discloses an catheter capable of
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`being an intravascular foreign matter suction assembly (Figure 2, 14) for sucking foreign
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`matter existing in a blood vessel, comprising: a quiding catheter (12) including a distal
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`end and a proximal end and forming a lumen (27) extending from the distal end to the
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`proximal end, the guiding catheter (12) configured to be inserted into a blood vessel
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`until a position on proximal side of a target location in the blood vessel is reached; and a
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`suction catheter (32) comprising a tubular portion provided on a distal side of the
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`suction catheter with an obliquely cul shape (distal tip near 36), the tubular portion
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`including a distal tube end and a proximal tube end, and a solid wire portion (34)
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`provided at the proximal tube end of said tubular portion and having a distal end
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`embedded in a wall (portion of 32) which forms said tubular portion, and wherein said
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`suction catheter (32) is configured to be inserted in said lurnen of said guiding catheter
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`(12) and said tubular portion is configured to project outwardly beyond the distal end of
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`said guiding catheter (section near 33) for removing foreign matter existing at the target
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`location in the blood vessel. Adams etal. further discloses a distal end protective
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`catheter (18), wherein the suction catheter (32) having a radiopaque marker (41, 42, 43)
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`in a vicinity of the proximal tube end of said tubular portion, wherein said guiding
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`catheter has a radiopaque (41) markerin a vicinity of the distal tube end of said tubular
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`portion, wherein an outer surface of said tubular portion of said suction catheter has a
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`lubricative coating (col 4, In 55-67), and wherein said tubular portion of said suction
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`catheter is more flexible than the distal end of said guiding catheter (cols 4-5, Figure 2).
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`
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`
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`Ex. 1021, 3-4.
`Ex. 1021, 3-4.
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`52. The Examiner also rejected claims in view of a combination of the
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`Adams catheter and prior art aspiration catheters, because these were viewed as
`
`analogous art, and it would have been obvious to combine angioplasty with
`
`removal of emboli.
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`
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`
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`Id., 4-5.
`
`53.
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`Thus, when the Itou patent claims were being examined, the
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`Examiner thought that references to an angioplasty catheter and to an aspiration
`
`catheter were in analogous art, recognizing that “a combination is proper.”
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`54.
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`Thus, a POSITA had the motivation and a reasonable expectation of
`
`success in using Itou’s suction catheter (2) to receive the “interventional cardiology
`
`devices” that “are insertable,” as discussed in 23.a, but also to receive the
`
`interventional cardiology devices disclosed in Ressemann, which include a balloon
`
`catheter and a balloon-expandable stent. See Ex. 1806, § III(A).
`
`55. Ressemann discloses “a substantially rigid side opening that includes
`
`a first inclined region, a second inclined region, and a non-inclined concave track
`
`between the first and second inclined regions.”
`
`
`
`56. As illustrated above, Fig. 16J depicts a support collar (2141), which
`
`includes a cylindrical portion (2141a) and tab portion (2141b). Ex. 1008, 24:55-62.
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`Collar 2141 has a first inclined slope (1) at its proximal end, a flat, non-inclined
`
`region, and second inclined slope at its distal end (2).
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`57. First, a POSITA had the motivation to modify the proximal end of the
`
`tubular portion of Itou’s suction catheter because s/he understood that it was
`
`configured to receive one or more stents or balloon catheters. Supra. And by
`
`modifying the proximal opening of suction catheter (2) with Ressemann’s collar
`
`2141, a larger area for receiving a stent and/or balloon catheter would be achieved.
`
`See also Ex. 1042 ¶¶ 92-93, 101 (IPR2020-00137).
`
`58. Second, Ressemann teaches that collar 2141 “serves to reinforce the
`
`proximal opening” of Ressemann’s evacuation head “in the presence of deforming
`
`forces, particularly torsional stresses that may be created unintentionally by
`
`rotation of the catheter shaft near its proximal end.” Ex. 1008, 24:49-55. The
`
`collar’s tab portion 2141b also “provides a flexibility transition between the
`
`proximal end of the evacuation head” and the “shaft of the evacuation assembly.”
`
`Ex. 1008, 24:64-67.
`
`59. A POSITA would also be motivated to modify the side opening of
`
`Itou’s catheter (2) with collar 2141 of Ressemann by substituting collar 2141 for
`
`Itou’s proximal tip 23 for these reasons as well.
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`60. The side opening disclosed above incorporates Ressemann’s collar
`
`2141, which is made of metal. Ex. 1008, 25:1-2. As discussed for limitation 23.c,
`
`below, the side opening and the substantially rigid portion together are used to
`
`advance catheter (2) within the guide catheter. The “side opening” is therefore
`
`“substantially rigid.”
`
`61. Thus, Itou modified with Ressemann discloses “a substantially rigid
`
`side opening that includes a first inclined region, a second inclined region, and a
`
`non-inclined concave track between the first and second inclined regions.”
`
`62.
`
`23.c
`
`Claim Language
`[23.c] “a
`substantially rigid
`portion proximal of
`and operably
`connected to, and
`more rigid along a
`longitudinal axis
`than, the f