Paper No. __________
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`
`
`MEDTRONIC, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`Case No: IPR2020-00126
`U.S. Patent No. 8,048,032
`______________________________
`
`PETITIONER’S REPLY
`
`

`

`TABLE OF CONTENTS
`
`Page
`TABLE OF CONTENTS ............................................................................................ i
`
`TABLE OF AUTHORITIES .................................................................................... iii
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`THE BOARD CAN ADOPT ITS PRELIMINARY CONSTRUCTION
`OF “INTERVENTIONAL CARDIOLOGY DEVICES”
`(INDEPENDENT CLAIMS 1, 11). ................................................................. 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, 11) ...................................................................... 6
`
`1.
`
`2.
`
`Itou discloses that all four types of interventional cardiology
`devices are insertable. ................................................................. 6
`
`The opening of Itou is actually larger, allowing larger devices
`through as well. ........................................................................... 8
`
`C.
`
`Itou Discloses or Renders Obvious Claims 3 and 14. ........................... 9
`
`1.
`
`2.
`
`GROUND 1: Itou discloses claims 3 and 14. ............................. 9
`
`GROUND 2: Itou in view of Ressemann renders claims 3 and
`14 obvious. ................................................................................ 10
`
`D. GROUND 1: Itou discloses a tubular structure that “includes a
`flexible cylindrical distal tip portion” (claim 6) .................................. 13
`
`E.
`
`GROUNDS 1, 2: Itou discloses or renders obvious claim 13 ............. 14
`
`IV.
`
`PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT—A RAPID-EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER. ................................. 16
`
`
`
`i
`
`

`

`A. Mother-in-child and Rx devices were well known, and so was
`the combination. .................................................................................. 18
`
`B.
`
`PO’s secondary consideration evidence all relates to prior art
`features and functionality. ................................................................... 19
`
`V.
`
`CONCLUSION .............................................................................................. 22
`
`
`
`
`
`
`
`ii
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`

`

`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) .......................................................................... 20
`
`KSR Int’l Co. v. Teleflex Inc.,
` 550 U.S. 398 (2007) ........................................................................................... 12
`
`Mars, Inc. v. H.J. Heinz Co.,
`377 F.3d 1369 (Fed. Cir. 2004) .......................................................................... 14
`
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed Cir. 2001) .................................................................. 9, 10
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 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
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 17
`
`
`
`
`
`iv
`
`

`

`I.
`
`INTRODUCTION
`
`Patent Owner (“PO”) cannot refute that Itou’s catheter (2) discloses the
`
`guide extension catheter (“GEC”) structure claimed in the patent. 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 through which all
`
`four listed devices are insertable.
`
`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. THE BOARD CAN ADOPT ITS PRELIMINARY CONSTRUCTION
`OF “INTERVENTIONAL CARDIOLOGY DEVICES”
`(INDEPENDENT CLAIMS 1, 11).
`
`The parties agree that “interventional cardiology device(s)” means “devices
`
`including, but not limited to, guidewires, balloon catheters, stents, and stent
`
`catheters.” Paper 1 (“Pet.”), 15-16. 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 group that includes, but is not limited to, guidewires, balloon
`
`catheters, stents, and stent catheters.” I.D., 12. 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, 10-11. This non-sequitur has no bearing on
`
`the construction of the claim term “interventional cardiology device(s).” PO does
`
`
`1 Petitioner reiterates its position on “interventional cardiology device(s)” to
`
`preserve for appeal. Pet., 15-16, 26-29.
`
`
`
`2
`
`

`

`not (because it cannot) support its contention that “standard coronary devices” is
`
`the same as “interventional cardiology devices.” Compare POR, 11-14 (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 should 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., 13, 20. 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., 11-13.
`
`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, 11-12. 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
`
`
`
`3
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`

`

`cardiology treatment device’ interchangeably with ‘interventional cardiology
`
`device[s],’” meaning that the latter must also provide treatment. Id., 12. But in
`
`support, all PO points to is the fact that the terms “interventional cardiology
`
`device(s),” “cardiac treatment device,” and “interventional cardiology treatment
`
`device” each include balloons and stents. Id., 12-13. 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. A
`
`patentee’s use of different words—referring to “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). The specification here never
`
`states that the terms means same thing. Ex-1806 ¶ 9. 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
`
`
`
`4
`
`

`

`does not provide treatment, such that it cannot be a “treatment device,” it does not
`
`follow that it cannot be an “interventional cardiology device.”
`
`The logical reading of the specification is that “interventional cardiology
`
`device(s)” refers to the genus, of which both “cardiac treatment device” and
`
`“interventional cardiology treatment device” are species. The former is not a
`
`synonym for the latter, which is consistent with a POSITA’s understanding of these
`
`terms. Ex-1806 ¶¶ 10-12. 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, 12-13 (citing Ex-1001, 4:30-34), 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, 94; 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. PO is wrong as set forth in
`
`Petitioner’s response on conception-reduction to practice. Paper 79.
`
`
`
`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, 11)
`
`Itou explicitly discloses a coaxial lumen through which two interventional
`
`cardiology devices (“IVCDs”) are insertable. Pet., 25-26 (regarding guidewire (6)
`
`and distal end protective catheter (5) being insertable through the coaxial lumen of
`
`catheter (2)); see Ex-1005 ¶ 198; Ex-1806 ¶ 45.
`
`1.
`
`Itou discloses that all four types of interventional cardiology
`devices are insertable.
`
`Itou inherently discloses that all four types of enumerated IVCDs are
`
`insertable, even in view of PO’s incorrect suggestion that the “effective size” of
`
`Itou’s opening was 0.046 inches. Itou explicitly teaches that guidewire (6) is
`
`insertable through catheter (2). Ex-1806 ¶ 45; Ex-1015a, 98. A POSITA also knew
`
`that angioplasty balloons were insertable through lumens with an opening of 0.045
`
`inches. Ex-1806 ¶ 46; Ex-1009, 4:46-50, 61-64. A POSITA was also aware of
`
`numerous stents—each of which was necessarily delivered on a stent catheter—
`
`that were insertable through an opening of 0.046 inches. Ex-1806 ¶¶ 47-52;
`
`Ex-1015b, 189; Ex-1802, 7; Ex-1803, 4:54-58; Ex-1804, Table 1.
`
`At least three reasons demonstrate that PO cannot credibly argue otherwise.
`
`First, Mr. Keith, PO’s expert, admits that Itou teaches advancing catheter (2) into
`
`the coronary vasculature, so that the distal part of tubular structure (24) is extended
`
`
`
`6
`
`

`

`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.
`
`
`
`Second, 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
`
`
`
`

`

`Ex-2138 ¶ 128 (modified by Petitioner).
`
`Third, 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-1805, 140:1-141:21.
`
`2.
`
`The opening of Itou is actually larger, allowing larger
`devices through as well.
`
`Itou teaches an opening of .059 inches, not .046 as argued by PO. The
`
`teaching of Itou is correct because the fully circumferential portion of the pushwire
`
`is not flush with the lumen, and the wire is flexible and bends in use. Ex-1806 ¶¶
`
`53-56; Ex-1807 ¶¶ 28-46.
`
`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 the fully-
`
`circumferential portion of wire (25) does not block catheter (2)’s proximal
`
`opening. Ex-1806 ¶56; Ex-1807 ¶¶35-39; see Ex-1762 at 153:1-10 (explaining that
`
`thinning a push rod out a bit prior to the weld point ensures that it does not
`
`interfere with stent delivery).
`
`Itou also teaches that the distal portion of catheter (2) is emphatically not
`
`rigid, as it must be navigated into a coronary artery. Ex-1007, Abstract, 5:35-42,
`
`Fig. 6. 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
`
`
`
`8
`
`

`

`“deep” in the coronary vasculature. Id., 1:66-2:5, 5:35-38, Fig. 6;
`
`Ex-1806 ¶¶53-55; 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 ¶¶ 52-56; Ex-1807 ¶¶ 30-39.
`
`C.
`
`Itou Discloses or Renders Obvious Claims 3 and 14.
`
`1. GROUND 1: Itou discloses claims 3 and 14.
`
`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, 25-27, 37-39; Ex-1805, 129:4-24
`
`(testifying that he had no opinion). Instead, PO argues that Medtronic 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, 24
`
`(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 patents.” Id. (citing 128 F.3d 1473, 1478
`
`(Fed. Cir. 1997); Mytee Prods., 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
`
`
`
`9
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`

`

`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.
`
`Itou teaches each structural limitation of claims 3 and 14 (Pet., 39-42, 60-
`
`62), 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
`
`¶¶59-60. That would result in an IVCD being inserted while the structure of Itou is
`
`within the guide catheter as claimed. Id.
`
`
`
`
`
`
`
`
`
`2. GROUND 2: Itou in view of Ressemann renders claims 3
`and 14 obvious.
`
`PO’s arguments reflect its belief that a POSITA would not have a
`
`“reasonable expectation of success in somehow making Itou into an embolic
`
`
`
`10
`
`

`

`protection device.” POR, 28. But this is not Medtronic’s argument. Itou in view of
`
`Ressemann renders these claims obvious while not requiring any change to
`
`catheter (2)’s structure. Pet., 67-72, 75-76. Medtronic 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. 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.
`
`Itou discloses a suction catheter, and Ressemann teaches an embolic
`
`protection device that is also used to deliver a stent. Id., 19-22, 65-69. 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 ¶¶67-69; 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
`
`
`
`11
`
`

`

`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. 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, 36; Ex-1806 ¶¶ 70-71. The idea that a POSITA
`
`would ignore Itou because it is described as a suction catheter 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. The toolkit includes guide catheters, guide
`
`wires, diagnostic catheters, angioplasty balloons, stents and stent catheters,
`
`embolic protection catheters and suction catheters. In practice, an interventional
`
`
`
`12
`
`

`

`cardiologist will look to every tool at his disposal. He would be aware that Itou
`
`could be used first to suction foreign matter from the coronary artery and then to
`
`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 ¶¶73-76; see also Ex-1811, 1435 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 . . . .
`
`Ex-1762, 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.
`
`Thus, the knowledge of a POSITA and the teachings of Itou and Ressemann
`
`render claims 3 and 14 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.
`
`
`
`13
`
`

`

`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 claim 6 requires is
`
`that the tubular structure include “a flexible cylindrical distal tip,” which Itou
`
`teaches. Pet., 45; see 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.
`
`Third, even if the inclined portion is not cylindrical, there is no exclusionary
`
`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
`
`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 13
`
`The Board need not reach this ground to invalidate claim 13. Nevertheless,
`
`Medtronic’s alternative theory of modifying Itou with the shape of the Ressemann
`
`collar is still obvious.
`
`
`
`14
`
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`PO focuses on the specific way that collar 2141 is incorporated into a single
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`Ressemann embodiment. But the law simply does not require that a component
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`from reference A be combined with reference B in exactly the same way as is
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`taught in reference A. Google LLC v. Lee, 759 F. App’x 992, 997 (Fed. Cir. 2019)
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`(“Our obviousness framework permits modifying one reference and combining it
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`with a second reference.”) And that is because a “reference must be considered for
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`everything that it teaches, not simply the described invention or a preferred
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`embodiment.” In re Applied Materials, 692 F.3d 1289, 1298 (Fed. Cir. 2012)
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`(emphasis added).
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`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 &
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`Dismantling Co. v. Genesis Attachments, 825 F.3d 1373, 1380 (Fed. Cir. 2016). In
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`Allied Erecting, one reference disclosed the desirability of simplifying disassembly
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`of jaws from a demolition tool, while a second reference taught providing a tool
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`with movable blades enabling a wide range of movement. Id., 1379. The Board
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`determined that even though design and structural changes were required, it would
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`have been obvious to a POSITA to modify the immobilized jaw of one tool in order
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`to ensure that it had a wider range of motion. Id., 1381. Thus, “[t]he test for
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`obviousness is not whether the features of a secondary reference may be bodily
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`incorporated into the structure of the primary reference . . . but rather whether ‘a
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`skilled artisan would have been motivated to combine the teachings of the prior art
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`references to achieve the claimed invention.’” Id.
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`Here, modifying Itou with Ressemann’s collar 2141 requires some re-design
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`of Itou’s catheter (2), but that design need not use Ressemann as a blue print.
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`Medtronic’s experts are uniformly clear that the particular construction of
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`Ressemann’s embodiment 2100 is not what they rely upon. Ex-2137,
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`122:25-123:14, 126:15-23, 132:1-133:11; Ex-2116, 132:1-133:12, 167:24-169:12.
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`To the contrary, they testify that they see benefits to incorporating collar 2141 into
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`the proximal opening of Itou’s catheter (2). Pet., 72-75. They set forth in detail the
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`motivation to make the combination. And—even though this level of detail is not
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`required under In re Applied Materials and Allied Erecting—they also described
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`how one would, from an engineering standpoint, incorporate collar 2141 into
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`catheter (2). Id.; see Ex-1807 ¶¶ 121-132.
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`IV. PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT—A RAPID-EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER.
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`The earliest rapid-exchange (“Rx”) GEC in the record is Kontos, followed
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`by Ressemann and Itou. These devices are Rx, configured to deliver a wide variety
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`of IVCDs, and provide increased back up support when extended partially past the
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`end of a GC. Ressemann and Itou also have a side opening. These devices—and
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`the functionality associated with them—were all published in the art in advance of
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`the 2004 Transcatheter Cardiovascular Therapeutics conference, where inventor
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`Root maintains he conceived of the idea claimed in the PO patents. Compare
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`Ex-1755 ¶¶ 27-38 with Ex-2118 ¶¶ 5-6.
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`Nevertheless, PO bases its entire secondary considerations case on these
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`features. POR, 58-59. PO makes the fundamental error of confusing
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`commercialization with invention. Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282-83
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`(1976) (holding secondary considerations, “without invention, will not make
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`patentability”). It does not matter if PO was first to market when the combination
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`of features it relies upon were in the prior art. In re Kao, 639 F.3d 1057, 1068-69
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`(Fed. Cir. 2011) (“Where the offered secondary consideration[s] actually results
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`from something other than what is both claimed and novel in the claim, there is no
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`nexus to the merits of the claimed invention.”).
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`PO calls out claims 3 and 13, which recite a side opening adapted to receive
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`IVCDs. Itou discloses these claims, and the only potential obviousness issue is
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`using Ressemann’s teaching to use different types of IVCDs. Ex-1806 ¶¶ 67-71,
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`205-219; Ex-1005 ¶¶ 226-257. On this record, PO cannot overcome Petitioner’s
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`strong showing of obviousness. ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1374
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`(Fed. Cir. 2018) (“[A] strong showing of obviousness may stand ‘even in the face
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`of considerable evidence of secondary considerations.’”).
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`17
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`A. Mother-in-child and Rx devices were well known, and so was the
`combination.
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`Rx technology was developed in the 1980s for balloon catheters.
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`Ex-2138 ¶ 71 (“[R]apid exchange functionality existed for almost two decades
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`before GuideLiner.”); Ex-2145 ¶ 82; Ex-1782, 39:1-22; Ex-1114, 111:13-17. There
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`was a trend in the industry toward full adoption through the 1990s and early 2000s.
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`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
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`61:24-62:9, 77:9-16, 121:12-122:1. Dr. Thompson concedes that the only
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`structures you need to apply the benefits of modern GEC catheters are Rx, a side
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`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-
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`child catheters are alleviated by the change to Rx, and all of the relevant benefits
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`he cites for GECs flow from the change from a mother-in-child to Rx design.
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`Ex-1820 at 23:15-26:22. Kontos, Itou, and Ressemann are Rx, close in size to the
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`GC, provide back up support, and the latter two have side openings.
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`18
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`B. PO’s secondary consideration evidence all relates to prior art
`features and functionality.
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`“If the feature that creates the commercial success was known in the prior
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`art, the success is not pertinent.” Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
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`1312 (Fed. Cir. 2006). PO’s cited marketing documents prominently emphasize
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`prior art functionality of “rapid exchange convenience” and “added backup
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`support.” POR at 60-63 (highlighting Ex-2155, -2158, -2161, -2164).
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`PO’s alleged “copying” evidence likewise focuses on prior art features and
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`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); In re Kao, 639
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`F.3d at 1068 (“Where the offered secondary consideration actually results from
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`something other than what is both claimed and novel in the claim, there is no nexus
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`to the merits of the claimed invention.”).
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`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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`2 PO has not submitted the Boston Scientific license or provided any context
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`surrounding it. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1324
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`(Fed. Cir. 2004) (finding licenses entitled to little weight “if the patentee does not
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`19
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`Boosting Catheter are Rx devices configured to deliver a wide variety of
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`cardiology devices and provi