Paper No. __________
`
`
`
`
`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: IPR2020-00128
`U.S. Patent No. RE45,380
`______________________________
`
`PETITIONER’S REPLY
`
`
`
`
`
`
`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: IPR2020-00128
`U.S. Patent No. RE45,380
`______________________________
`
`PETITIONER’S REPLY
`
`
`
`TABLE OF CONTENTS
`
`Page
`TABLE OF CONTENTS ............................................................................................ i
`
`TABLE OF AUTHORITIES .................................................................................... iii
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`CONSTRUCTION OF “INTERVENTIONAL CARDIOLOGY
`DEVICES” (INDEPENDENT CLAIMS 1, 12) .............................................. 2
`
`III.
`
`ITOU INVALIDATES ALL CHALLENGED CLAIMS ................................ 5
`
`A.
`
`Itou is prior art. ...................................................................................... 5
`
`B. GROUND 1: Itou discloses a tubular structure/flexible tip
`portion “defining a coaxial lumen having a cross-sectional inner
`diameter through which interventional cardiology devices are
`insertable” (claims 1, 12) ...................................................................... 6
`
`1.
`
`2.
`
`Itou discloses that all four types of interventional
`cardiology devices are insertable. .............................................. 6
`
`PO is mistaken as to the “effective size” of the opening to
`the lumen of catheter (2). ........................................................... 8
`
`C.
`
`Itou discloses or renders obvious claims 3 and 15. ............................... 9
`
`1.
`
`2.
`
`GROUND 1: Itou discloses claims 3 and 15. ............................ 9
`
`GROUND 2: Itou in view of Ressemann renders claims 3
`and 15 obvious. ........................................................................ 11
`
`D. GROUND 1: Itou discloses a tubular structure that “includes a
`flexible cylindrical distal tip portion” (claim 6) .................................. 14
`
`E.
`
`GROUNDS 1, 2: Itou discloses or renders obvious claim 14 ............. 15
`
`IV.
`
`PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT-A RAPID EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER. ................................. 17
`
`
`
`i
`
`
`
`1. Mother-in-child and Rx devices were well known, and so
`was the combination. ............................................................... 18
`
`2.
`
`PO’s secondary consideration evidence all relates to prior
`art features and functionality. ................................................... 19
`
`V.
`
`AIA PATENT. ................................................................................................ 22
`
`VI. CONCLUSION .............................................................................................. 23
`
`
`
`
`
`
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Accent Packaging, Inc. v. Leggett & Platt, Inc.,
`707 F.3d 1318 (Fed. Cir. 2013) ............................................................................ 5
`
`Allied Erecting & Dismantling Co. v. Genesis Attachments,
`825 F.3d 1373 (Fed. Cir. 2016) .................................................................... 15, 16
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .......................................................................... 19
`
`Google LLC v. Lee,
`759 F. App’x 992 (Fed Cir. 2019) ...................................................................... 15
`
`In re Applied Materials,
`692 F.3d 1289 (Fed. Cir. 2012) .................................................................... 15, 16
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .............................................................. 17, 19, 20
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 21
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 13
`
`Mars, Inc. v. H.J. Heinz Co.,
`377 F.3d 1369 (Fed. Cir. 2004) .......................................................................... 14
`
`Mytee Products, Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed Cir. 2001) ...................................................................... 10
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (2006) .......................................................................................... 19
`
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ............................................................................................ 17
`
`
`
`iii
`
`
`
`Synqor, Inc. v. Artesyn Techs., Inc.,
`No. 2:07-CV-497-TJW-CE, 2010 WL 2991037 (E.D. Tex. July 26,
`2010), aff’d, 709 F.3d 1365 (Fed. Cir. 2013) ....................................................... 4
`
`Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc.,
`774 F.3d 968 (Fed. Cir. 2014) ............................................................................ 11
`
`W.M. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .......................................................................... 19
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 18
`
`
`
`
`
`iv
`
`
`
`I.
`
`INTRODUCTION
`
`PO cannot refute that Itou’s catheter (2) discloses the GEC structure
`
`claimed. Itou anticipates. PO can only repeat its argument, rejected at institution,
`
`that the term “interventional cardiology devices” (“IVCD”) requires all four types
`
`of devices listed in the specification. PO adds that any additional device must
`
`provide “treatment.” These arguments are incorrect and ultimately irrelevant
`
`because Itou inherently discloses a tubular structure defining a coaxial lumen
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`through which all four listed devices are insertable.
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`Similarly, PO attacks claims 3, 13, and 14 as though they are method claims.
`
`They are device claims, and Medtronic’s evidence establishes that Itou discloses
`
`the recited device’s structure. PO argues that Medtronic did not show the
`
`structures inherently performing the claimed functions, but this misstates the law.
`
`Once Medtronic established Itou’s structural disclosure, the burden was PO’s to
`
`show that Itou’s structure does not inherently possess the functionally defined
`
`limitations. It has not done so.
`
`Finally, Medtronic’s back up obviousness grounds are correct, because
`
`Ressemann is analogous art and provides the express teaching to use the GEC
`
`structure of Itou to receive and deliver devices.
`
`
`
`1
`
`
`
`II. CONSTRUCTION OF “INTERVENTIONAL CARDIOLOGY
`DEVICES” (INDEPENDENT CLAIMS 1, 12)
`
`The parties agree that “interventional cardiology device(s)” means “devices
`
`including, but not limited to, guidewires, balloon catheters, stents, and stent
`
`catheters.” Pet., 16. Medtronic maintains that “interventional cardiology device(s)”
`
`requires that the lumen of the tubular structure is sized to receive only one such
`
`device.1 In its Institution Decision, the Board found that “‘interventional
`
`cardiology devices’ refers to at least two types of the devices selected from the
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`group that includes, but is not limited to, guidewires, balloon catheters, stents, and
`
`stent catheters.” I.D., 10. But because resolution of this question—whether
`
`interventional cardiology devices requires one or two such devices—does not
`
`impact the outcome of this IPR; the Board can adopt its preliminary construction of
`
`“interventional cardiology devices.”
`
`In its POR, PO advances only one new argument: the Board’s construction
`
`ignores that the specification states that the purported invention facilitates delivery
`
`of “standard coronary devices.” POR, 10. This non-sequitur has no bearing,
`
`though, on the construction of the claim term “interventional cardiology
`
`device(s).” PO does not (because it cannot) support its contention that “standard
`
`
`1 Petitioner reiterates its position on “interventional cardiology device(s)” to
`
`preserve for appeal. Pet., 16, 25-27.
`
`
`
`2
`
`
`
`coronary devices” is the same as “interventional cardiology devices.” Compare
`
`IPR2020-00126, Paper 44, 11 (PO arguing construction of “interventional
`
`cardiology device(s)” requires that the device “provide treatment”), with Ex-1800,
`
`63:20-64:1 (stating that some, but not all, standard coronary devices provide
`
`treatment). The Board should not reconsider its construction of “interventional
`
`cardiology device(s)” and can adopt its construction from the Institution Decision.
`
`At institution, the Board correctly concluded that this limitation
`
`encompasses more than just four devices specifically enumerated in the
`
`specification. I.D., 9-11, 18. The specification’s use of the phrase “include but not
`
`be limited to” is instructive in the determination that Itou's protective catheter 5 is
`
`an “interventional cardiology device(s).” Id., 8-9.
`
`PO attempts to overcome the Board's interpretation by introducing a limiting
`
`construction requiring interventional cardiology devices to be “delivered beyond
`
`the end of the device for use with a standard guide catheter to a location in the
`
`cardiac vasculature requiring treatment, to provide treatment to that location.”
`
`POR, 23. PO then argues that because Itou's protective catheter 5 does not provide
`
`treatment, it cannot be an interventional cardiology device.
`
`PO’s argument fails because it is premised on the mistaken belief that “the
`
`specification uses the term ‘cardiac treatment device’ and ‘interventional
`
`cardiology treatment device’ interchangeably with ‘interventional cardiology
`
`
`
`3
`
`
`
`device[s],’” meaning that the latter must also provide treatment. POR, 12. But in
`
`support, all PO points to is the fact that “interventional cardiology device(s),”
`
`“cardiac treatment device,” and “interventional cardiology treatment device” each
`
`include balloons and stents. POR, 12-13 (emphasis added). This is not enough,
`
`however, to establish that the three terms have identical definitions.
`
`As a threshold matter, PO's argument is not supported by the specification.
`
`Ex-1806 ¶¶ 7-13. Further, patentee’s use of different words—referring to a
`
`‘treatment devices’ in some portions of the specification and “interventional
`
`cardiology devices” in different portions—is presumed to have different meanings.
`
`Synqor, Inc. v. Artesyn Techs., Inc., No. 2:07-CV-497-TJW-CE, 2010 WL 2991037,
`
`at *15 (E.D. Tex. July 26, 2010) (“The Court has consistently held that when the
`
`claims and specification use different terms, that those different terms should
`
`normally not be given the same meaning.”), aff’d, 709 F.3d 1365 (Fed. Cir. 2013).
`
`For this reason, PO’s argument—premised on Itou’s protective catheter 5 being
`
`analogized to the patent’s tapered inner catheter, which, according to PO, the
`
`specification implies is not a “cardiac treatment device” or an “interventional
`
`cardiology treatment device”—must fail. Stated another way, even assuming a
`
`tapered inner catheter does not provide treatment, such that it cannot be a
`
`“treatment device,” it does not follow that it cannot be an “interventional
`
`cardiology device.”
`
`
`
`4
`
`
`
`The logical reading of the specification is that “interventional cardiology
`
`device(s)” refers to the genus, of which both “cardiac treatment device” and
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`“interventional cardiology treatment device” are species, Ex-1806 ¶¶ 10-13, which
`
`is consistent with POSITA’s understanding of these terms. The former is not a
`
`synonym for the latter, and the specification’s teachings regarding sequential use of
`
`a tapered inner catheter and then “a cardiac treatment device, such as a guidewire,
`
`balloon or stent,” POR, 13 (citing Ex-1001, 4:53-56), are irrelevant.
`
`PO’s proposed construction is also incorrect because it would read out
`
`guidewires, which the specification explicitly defines as IVCDs. See Accent
`
`Packaging, Inc. v. Leggett & Platt, Inc., 707 F.3d 1318, 1326 (Fed. Cir. 2013). A
`
`guidewire does not provide treatment. Instead, it is “a rail over which a series of
`
`therapeutic devices can be advanced.” Ex-1015a, 548; Ex-1806 ¶ 13. PO’s expert,
`
`Dr. Graham, agrees, testifying that a guidewire does not provide treatment by
`
`itself, but is used with a stent or balloon. Ex-1801, 89:2-23.
`
`III.
`
`ITOU INVALIDATES ALL CHALLENGED CLAIMS
`
`A.
`
`Itou is prior art.
`
`PO argues that Itou is not prior art. POR, 1. For the reasons set forth in
`
`Petitioner’s response on conception-reduction to practice, Paper 78, PO is wrong.
`
`
`
`5
`
`
`
`B. GROUND 1: Itou discloses a tubular structure/flexible tip portion
`“defining a coaxial lumen having a cross-sectional inner diameter
`through which interventional cardiology devices are insertable”
`(claims 1, 12)
`
`Itou discloses a coaxial lumen through which two interventional cardiology
`
`devices (“IVCDs”) are insertable. Pet., 25-27 (regarding guidewire (6) and distal
`
`end protective catheter (5) being insertable through the coaxial lumen of catheter
`
`(2)); see also Ex-1806 ¶ 45.
`
`1.
`
`Itou discloses that all four types of interventional cardiology
`devices are insertable.
`
`If the “effective size” of Itou’s opening was 0.046 inches, as PO wrongly
`
`suggests, Itou still inherently discloses that all four types of enumerated IVCDs are
`
`insertable. Itou explicitly teaches that guidewire (6) is insertable through catheter
`
`(2), and a POSITA knew that guidewires ranged from 0.010 to 0.018 inches. Ex-
`
`1806 ¶ 45; Ex-1015a, 551. As Dr. Brecker explains, a POSITA would have known
`
`that angioplasty balloons were insertable through lumen with an opening of 0.045
`
`inches. Ex-1806 ¶ 46; Ex-1009, 4:46-48, 61-64. Additionally, a POSITA was also
`
`aware of numerous stents that were insertable through an opening of 0.046 inches.
`
`Ex-1806 ¶¶ 47-51; Ex-1015b, 189; Ex-1802, 4, 7, 14-15, 21, 25; Ex-1803, 4:54-58;
`
`Ex-1804, Table 2, Fig. 3.
`
`PO cannot credibly argue otherwise. Here, Mr. Keith admits (as he must)
`
`that Itou teaches advancing catheter (2) into the coronary vasculature, so that the
`
`
`
`6
`
`
`
`distal part of tubular structure (24) is extended into the vasculature, but the
`
`proximal opening remains within the guide catheter. Ex-1805, 137:7-138:16; Ex-
`
`1007, 5:35-42; 7:13-18.
`
`Ex-1007, Fig. 6.
`
`
`
`Mr. Keith also admits that a guidewire could be navigated into guiding
`
`catheter 1—and then through the guide catheter and right up to the opening of
`
`catheter (2)—but then has no idea whether it would be able to enter the opening.
`
`Ex-1805, 143:3-145:20.
`
`
`
`7
`
`
`
`
`
`Modified from Ex-2138 ¶ 128.
`
`Mr. Keith’s testimony is questionable, as the 5 French version of GuideLiner
`
`v.3 also has an ID of 0.046 inches and is marketed for delivering stents, which are,
`
`of course, much larger than a guidewire. Ex-2159.
`
`2.
`
`PO is mistaken as to the “effective size” of the opening to
`the lumen of catheter (2).
`
`PO ignores Itou’s express teaching, Ex-1007, Table 1, arguing that the
`
`“effective size” of catheter 2’s lumen opening is smaller “if [it] used to introduce
`
`interventional cardiology devices.” POR, 21. But this could only possibly be the
`
`case if (a) the fully circumferential portion of wire 25 was flush with catheter 2’s
`
`lumen; and (b) catheter 2 was entirely inflexible. Neither is true. Ex-1806 ¶¶ 53-57;
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`Ex-1807 ¶¶ 28-46.
`
`To the contrary, catheter (2)’s angulated proximal opening presents its
`
`widest diameter at a substantial angle to wire 25, which tapers as it is welded to
`
`collar 231 (“crushed into a form of a flat plate”). The flattening of wire 25 means
`
`
`
`8
`
`
`
`the fully-circumferential portion of wire (25) does not block catheter (2)’s
`
`proximal opening. Ex-1806 ¶ 56; Ex-1807 ¶¶ 35-39; see also Ex-1114, 75:20-76:6
`
`(
`
`
`
`).
`
`Additionally, Itou teaches that the distal portion of catheter (2) is
`
`emphatically not rigid, as it must be navigated into a coronary artery. Ex-1007,
`
`Abstract; Fig. 6; 5:35-42. This necessarily requires that the distal tubular portion of
`
`catheter (2) bend, as—if it did not—it could never be positioned where Itou
`
`instructs, which is “deep” in the coronary vasculature. Id., 2:1; 5: 35-38; Fig. 6.
`
`Ex-1806 ¶¶ 54-55; Ex-1807 ¶ 36.
`
`Collectively, the structure and flexibility of catheter (2) mean that the
`
`“effective size” of its’ opening is exactly what Itou teaches: 1.5 mm, or 0.059
`
`inches. Ex-1806 ¶¶ 53-56; Ex-1807 ¶¶ 30-39.
`
`C.
`
`Itou discloses or renders obvious claims 3 and 15.
`
`1. GROUND 1: Itou discloses claims 3 and 15.
`
`PO cannot dispute that (a) the proximal portion of Itou’s tubular structure
`
`comprises structure defining a side opening extending for a distance along a
`
`longitudinal axis; or (b) the side opening is accessible from a longitudinal side
`
`defined transverse to the longitudinal axis. POR, 24-28, 38-39; see also Ex-1805,
`
`129:4-24 (testifying that he had no opinion). Instead, PO argues that Medtronic
`
`
`
`9
`
`
`
`cannot prevail because it did not show that Itou inherently “performs the claimed
`
`function of receiving an IVCD when positioned within the guide catheter.” POR,
`
`25 (emphasis added). This argument is based on an incorrect application of law.
`
`PO argues that In re Schreiber “did not establish a presumption of inherency
`
`[based on structural similarity] for issued patent.” POR, 25, citing 128 F.3d 1473,
`
`1478 (Fed. Cir. 1997) and Mytee Products, Inc. v. Harris Research, Inc., 439 F.
`
`App’x 882, 886 (Fed Cir. 2001). But PO conveniently omits the very next sentence
`
`of Mytee, which explains that Schreiber holds “that after establishing a prima facie
`
`case of anticipation,” the burden shifts to the patent owner “‘to show that the prior
`
`art structure did not inherently possess the functionally defined limitation of the
`
`claimed apparatus.’” 439 F. App’x at 886 (citing Schreiber, 128 F.3d at 1478).
`
`Itou teaches each structural limitation of claims 3 and 15, Pet., 42-46, 61-63,
`
`including that catheter (2) necessarily accommodates the insertion of a guidewire,
`
`balloon, stent and stent catheter. § III.B, supra. Thus, it is PO’s burden—not
`
`Medtronic’s—to establish that Itou cannot receive an IVCD when positioned
`
`within the guide catheter. PO has not done so, and the Board need look no further.
`
`A POSITA would also understand from Itou’s teaching that catheter (5) is
`
`withdrawn, but a physician may wish to reinsert it. Ex-1007, 7:16-19; Ex-1806
`
`¶¶ 59-61. That would result in an IVCD being inserted while the structure of Itou is
`
`within the guide catheter as claimed. Id.
`
`
`
`10
`
`
`
`
`
`
`
`
`
`
`
`2. GROUND 2: Itou in view of Ressemann renders claims 3
`and 15 obvious.
`
`PO’s arguments are grounded in the idea that a POSITA would not have a
`
`“reasonable expectation of success in somehow making Itou into an embolic
`
`protection device.” POR, 29. But no one has suggested that. Itou in view of
`
`Ressemann renders these claims obvious while requiring not a single change to
`
`catheter (2)’s structure. Pet., 67-72, 75-76. Petitioner relies on Ressemann simply
`
`for the teaching of using a catheter lumen to receive IVCDs while inside a guide
`
`catheter, to the extent the Board does not find anticipation.
`
`Itou and Ressemann are analogous art that may be appropriately combined.
`
`See Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc., 774 F.3d 968, 979
`
`(Fed. Cir. 2014). In Tyco claims to a dual cam, ultrasonic coagulation tool were
`
`obvious in view of a single cam version of the same and a different surgical
`
`instrument with a pair of cams. Even though the latter was not “an ultrasonic
`
`surgical device, and therefore [did] not share the same field of endeavor,” it was
`
`“nevertheless analogous art” as it was “reasonably pertinent to the particular
`
`problem with which the inventor is involved.” Id.
`
`
`
`11
`
`
`
`Itou discloses a suction catheter, and Ressemann teaches an embolic
`
`protection device that is also used to deliver a stent. Id., 19-21, 66-71. The patent
`
`claims, Itou, and Ressemann all share the same field of endeavor, as they are all
`
`coronary catheters designed to provide solutions to the problem of coronary artery
`
`occlusion. Ex-1806 ¶¶ 64-78; see also Ex-1805, 20:7-21:2, 70:13-72:1 (PO’s
`
`expert acknowledging that angioplasty, artherectomy, and embolic protection
`
`catheters designed to deliver stents are all directed to improving coronary blood
`
`flow). This is evident from the disclosures of Itou and Ressemann themselves (Ex-
`
`1007; Ex-1008), as well as from their prosecution histories. Itou’s claims were
`
`rejected in view of a combination of angioplasty and aspiration catheter prior art
`
`because the references were analogous art. Pet., 72. And several references cited on
`
`the face of Ressemann relate to aspiration catheters. Ex-1806 ¶ 69 (citing Ex-
`
`1019); Ex-1808; Ex-1809; Ex-1810. There is no doubt that Itou and Ressemann are
`
`analogous art, from the same field of endeavor.
`
`The prior art expressly taught sizing the lumen of embolic protection and
`
`aspiration catheters so that angioplasty catheters and stents/stent catheters could be
`
`delivered through them. Pet., 69-71. As explained in the petition and above, Itou’s
`
`catheter (2) is precisely the right size for delivering angioplasty or stent catheters,
`
`and is navigated to precisely the right location to do so. Id., 19-20, 25-26, 39. The
`
`idea that a POSITA would ignore Itou because it is described as a suction catheter
`
`
`
`12
`
`
`
`and not a guide extension catheter makes no sense. KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398, 420-21 (2007). There is no meaningful structural difference between
`
`the claims and Itou.
`
`As Dr. Brecker explains, an interventional cardiologist will approach cases
`
`knowing that he has a toolkit to use, which includes guide catheters, guide wires,
`
`diagnostic catheters, angioplasty balloons, stents and stent catheters, embolic
`
`protection catheters and suction catheters. Ex-1806 ¶ 74. An interventional
`
`cardiologist would be aware that Itou could be used first to suction foreign matter
`
`from the coronary artery and to then deliver a stent. He would know that Itou’s
`
`catheter (2) could sequentially deploy a distal end protection device, deliver a
`
`stent, and then suction. And, given its structure, he would know that catheter (2)
`
`could be used solely to deliver a stent. Ex-1806 ¶¶ 75-76; see also Ex-1811, Table
`
`1.
`
`The alleged invention of GuideLiner itself grew from prior work on a
`
`suction catheter. As PO’s inventor Mr. Root testified:
`
`[T]he distal portion of the GuideLiner is a round tube, wide open. We
`
`wanted the thinnest wall possible. We want it to flex within the coronary
`
`artery, but we want it to have column support so you could push it and
`
`it doesn't buckle or kink. And that same requirement for the round tube
`
`exists in the Pronto, which is an aspiration catheter ….
`
`
`
`13
`
`
`
`Ex-1762 (Root depo), 46:9-20. In fact, VSI used the same technology it used in its
`
`Pronto suction catheter to make the distal tube for the GuideLiner. Id., 45:10-17.
`
`The knowledge of a POSITA and the teachings of Itou and Ressemann
`
`render claims 3 and 15 are obvious.
`
`D. GROUND 1: Itou discloses a tubular structure that “includes a
`flexible cylindrical distal tip portion” (claim 6)
`
`Itou discloses this element despite PO’s observation that the most distal
`
`portion of tip (22) is inclined.
`
`First, about half of tip (22) is fully circumferential, should that be required.
`
`The plain language of claim 6 does not require that the “flexible cylindrical distal
`
`tip portion” be the most distal portion of the catheter. All that it requires is that the
`
`tubular structure include “a flexible cylindrical distal tip,” which Itou teaches. Pet.,
`
`36-37; see also Ex-1077, 293:18-294:3 (PO’s expert opining that “just because
`
`something is proximal to something else doesn’t mean that is has to be entirely
`
`proximal).
`
`Second, there is no reason that even the inclined portion of tip (22) cannot be
`
`considered cylindrical based on its tubular shape, even if not fully circumferential.
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`Third, even if the inclined portion is not cylindrical, there is no exclusionary
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`language that would restrict the claimed “distal tip portion” from including both
`
`cylindrical and non-cylindrical regions. To the contrary, the claim uses the word
`
`“includes,” instead of the more restrictive “consists of,” which “does not exclude
`
`
`
`14
`
`
`
`additional, unrecited elements.” Mars, Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1375-
`
`76 (Fed. Cir. 2004).
`
`E. GROUNDS 1, 2: Itou discloses or renders obvious claim 14
`
`The Board need not reach this ground to invalidate claim 14. Nevertheless,
`
`Medtronic’s alternative theory of modifying Itou with the shape of the Ressemann
`
`collar is still obvious.
`
`PO focuses on the specific way that collar 2141 is incorporated into a single
`
`Ressemann embodiment. But the law simply does not require that a component
`
`from reference A be combined with reference B in exactly the same way as is
`
`taught in reference A. Google LLC v. Lee, 759 F. App’x 992, 998 (Fed Cir. 2019)
`
`(“Our obviousness framework permits modifying one reference and combining it
`
`with a second reference.”) And that is because “[a] reference must be considered
`
`for everything that it teaches, not simply the described invention or a preferred
`
`embodiment.” In re Applied Materials, 692 F.3d 1289, 1298 (Fed. Cir. 2012)
`
`(emphasis added).
`
`Claims may nonetheless be obvious even if a prior art combination requires
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`“substantial redesign and reconstruction” of a reference. Allied Erecting &
`
`Dismantling Co. v. Genesis Attachments, 825 F.3d 1373, 1380-81 (Fed. Cir. 2016).
`
`In Allied Erecting, one reference disclosed the desirability of simplifying
`
`disassembly of jaws from a demolition tool, while the other taught providing a tool
`
`
`
`15
`
`
`
`with movable blades enabling a wide range of movement. Id., 1379. The Board
`
`determined that even though design and structural changes were required, it would
`
`have been obvious to a POSITA to modify the immobilized jaw of one tool in order
`
`to ensure that it had a wider range of motion. Id., 1381. Thus, “[t]he test for
`
`obviousness is not whether the features of a secondary reference may be bodily
`
`incorporated into the structure of the primary reference . . . but rather whether a
`
`skilled artisan would have been motivated to combine the teachings of the prior art
`
`references to achieve the claimed invention.” Id., 1381.
`
`Here, modifying Itou with Ressemann’s collar 2141 requires some re-design
`
`of Itou’s catheter (2), but that design need not use Ressemann as a blue print.
`
`Medtronic’s experts are uniformly clear that the particular construction of
`
`Ressemann embodiment 2100 is not what they rely upon. Ex-2137, 122:25-123:14;
`
`126:15-23; 132:1-133:9; Ex-2116, 132:1-133:12; 167:24-169:12. To the contrary,
`
`they testify that they see benefits to incorporating collar 2141 into the proximal
`
`opening of Itou’s catheter (2). Pet., 72-75; Ex-1005; Ex-1042. They set forth in
`
`detail the motivation to make the combination. And—even though this level of
`
`detail is not required under In re Applied Materials and Allied Erecting—they also
`
`described how one would, from an engineering standpoint, incorporate collar 2141
`
`into catheter (2). Id.; see also Ex-1807 ¶¶ 121-132.
`
`
`
`16
`
`
`
`IV. PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT-A RAPID EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER.
`
`The earliest rapid-exchange (“Rx”) guide extension catheter (“GEC”) in the
`
`record is Kontos, followed by Ressemann and Itou. These devices are Rx,
`
`configured to deliver a wide variety of IVCDs, and provide increased back up
`
`support when extended partially past the end of a GC. Ressemann and Itou also
`
`have a side opening. These devices—and the functionality associated with them—
`
`were all published in the art in advance of the 2004 Transcatheter Cardiovascular
`
`Therapeutics conference, where inventor Root maintains he conceived of the idea
`
`claimed in the PO patents. Compare Ex-1755 ¶¶ 27-37 with Ex-2118 ¶ 5.
`
`Nevertheless, PO bases its entire secondary considerations case on these
`
`features. POR, 57-59. PO makes the fundamental error of confusing
`
`commercialization with invention. Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282-83
`
`(1976) (holding secondary considerations, “without invention, will not make
`
`patentability”). It does not matter if PO was first to market when the combination
`
`of features it relies upon were in the prior art. In re Kao, 639 F.3d 1057, 1068−69
`
`(Fed. Cir. 2011) (“Where the offered secondary consideration[s] actually results
`
`from something other than what is both claimed and novel in the claim, there is no
`
`nexus to the merits of the claimed invention.”).
`
`
`
`17
`
`
`
`In this IPR, PO calls out only claims 3 and 14, which recite a side opening
`
`adapted to receive IVCDs. Itou discloses these claims, and the only potential
`
`obviousness issue is using Ressemann’s teaching to use different types of
`
`interventional cardiology devices. Ex-1005 ¶¶ 198-203, 219, 229-74. On this
`
`record, PO cannot overcome Petitioner’s strong showing of obviousness. ZUP,
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`LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1374 (Fed. Cir. 2018) (“[A] strong showing
`
`of obviousness may stand ‘even in the face of considerable evidence of secondary
`
`considerations.’”).
`
`1. Mother-in-child and Rx devices were well known, and so
`was the combination.
`
`Rx technology was developed in the 1980s for balloon catheters. Ex-2138
`
`¶ 71 (“[R]apid exchange functionality existed for almost two decades before
`
`GuideLiner.”); Ex-2145 ¶ 82; Ex-1782, 39:1-22; Ex-1114, 111:13-17. There was a
`
`trend in the industry toward full adoption through the 1990s and early 2000s.
`
`Ex-1800, 26:10-27:8; Ex-1817 at 25:20-26:9, 37:8-38:6. Full-length
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`mother-in-child was also known to provide guide extension and additional backup
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`support. Ex-1800, 16:22-17:16; Ex-1762 at 194:5-15; Ex-1817 at 25:20-26:9;
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`Ex-1820 at 36:3-10; Ex-2123 ¶ 20. As stated by inventor Root in his earliest notes
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`and throughout his testimony, the alleged invention was to make an Rx version of a
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`mother-in-child catheter. Ex-1762, 39:19-21, 67:23-68:1; Ex-2003; Ex-1114 at
`
`61:24-62:9, 77:9-16, 121:12-122:1. Dr. Thompson concedes that the only
`
`
`
`18
`
`
`
`structures you need to apply the benefits of modern GEC catheters are Rx, a side
`
`opening, and a lumen relatively close to the size of the GC. Ex-1817 at 63:10-64:8;
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`Ex-2215 ¶ 22. Dr. Azzalini concedes that all of the drawbacks he lists of mother-in-
`
`child catheters are alleviated by the change to Rx, and all of the relevant benefits
`
`he cites for GECs flow from the change from a mother-in-child to Rx design. Ex-
`
`1820, 23:15-26:22. Kontos, Itou, and Ressemann are Rx, close in size to the GC,
`
`provide back up support, and the latter two have side openings.
`
`2.
`
`PO’s secondary consideration evidence all relates to prior
`art features and functionality.
`
`“If the feature that creates the commercial success was known in the prior
`
`art, the success is not pertinent.” Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
`
`1312 (2006). PO’s cited marketing documents prominently emphasize prior art
`
`functionality of “rapid exchange convenience” and “added backup support.” POR,
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`60-62 (highlighting Ex-2155, Ex-2158, Ex-2161, Ex-2164).
`
`PO’s alleged copying evidence likewise focuses on prior art features and
`
`functionality. Copying is not relevant to prove nonobviousness where, as here, the
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`feature that is copied is present in the prior art. Amazon.com, Inc. v.
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`Barnesandnoble.com, Inc., 239 F.3d 1343, 1366 (Fed. Cir. 2001); W.M. Wrigley Jr.
`
`Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012); see also In
`
`re Kao, 639 F.3d at 1068 (“Where the offered secondary consideration actually
`
`
`
`19
`
`
`
`results from something other than what is both claimed and novel in the claim,
`
`there is no nexus to the merits of the claimed invention.”).
`
`PO compares competing products to various versions of GuideLiner, but
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`ignores that the claimed features allegedly establishing nexus (and copying) are
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`clearly disclosed in the prior art. Like Itou and Ressemann, Guidezilla2 and The
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`Boosting Catheter are Rx devices configured to deliver a wide variety of
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