`
`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
`_________________
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S CORRECTED MOTION TO AMEND
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Proposed Claims 23-25 Lack Written Description or Are Indefinite. ............. 1
`
`A.
`
`Claims reciting a side opening outside of the substantially rigid
`portion lack support. .............................................................................. 1
`
`B.
`
`Proposed claims 23-25 are indefinite. .................................................11
`
`III. The Prior Art Renders Proposed Claims 23-25 Unpatentable ......................11
`
`A.
`
`B.
`
`Claim Construction..............................................................................12
`
`Substitute claims 23-25 are unpatentable over Itou in view of
`Ressemann or Kataishi. .......................................................................12
`
`1.
`
`2.
`
`3.
`
`Substitute Claim 23 ...................................................................12
`
`Substitute Claim 24 ...................................................................22
`
`Substitute Claim 25 ...................................................................24
`
`C.
`
`Substitute claims 23-25 are unpatentable over Kontos in view of
`Ressemann and Takahashi. .................................................................25
`
`1.
`
`2.
`
`3.
`
`Substitute Claim 23 ...................................................................25
`
`Substitute Claim 24 ...................................................................30
`
`Substitute Claim 25 ...................................................................35
`
`D.
`
`Combining Kontos with Kataishi for Claims 23-25 ...........................35
`
`IV. Conclusion .....................................................................................................35
`
`
`
`
`
`i
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ............................................................................ 5
`
`ICU Medical, Inc. v. Alaris Medical Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .......................................................................... 10
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................ 18
`
`PowerOasis Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) ............................................................................ 4
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .......................................................................... 23
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 5
`
`
`
`
`ii
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`I.
`
`INTRODUCTION
`
`Medtronic, Inc., and Medtronic Vascular, Inc., (“Petitioner”) opposes Patent
`
`Owner’s Corrected Contingent Motion to Amend (“Mot.”). Patent Owner (“PO”)
`
`seeks to amend claims 1, 11, and 16 and proposes substitute claims 23-25. (Mot., 1,
`
`Appendix A (“App.”).) But the substitute claims are not supported by the original
`
`disclosure and are unpatentable over the prior art. PO’s Motion should be denied.
`
`II.
`
`PROPOSED CLAIMS 23-25 LACK WRITTEN DESCRIPTION OR
`ARE INDEFINITE.
`
`A. Claims reciting a side opening outside of the substantially rigid
`portion lack support.
`
`Proposed claim 23 recites a “device for use with a standard 6 French guide
`
`catheter … comprising, in a distal-to-proximal direction … a flexible tip portion …
`
`[a] side opening … and a substantially rigid portion[.]” (App., 1-2.)1 Similarly,
`
`proposed claim 24 recites “a side opening positioned between a proximal end of the
`
`reinforced portion and a distal end of the substantially rigid portion.” (Id., 4.) A
`
`POSITA would understand that claims 23 and 24 require a side opening that is
`
`separate from (distal to) the “substantially rigid portion.” (Ex. 1919, ¶¶ 48-52;
`
`see also Mot., 4 (“The claim need not expressly recite that the side opening is in the
`
`substantially rigid portion.”).) But the written description exclusively and repeatedly
`
`
`1 All emphasis and annotations added unless otherwise specified.
`
`1
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`describes the side opening as part of the substantially rigid portion of the claimed
`
`device. Thus, proposed claims 23 and 24 should be rejected for lack of written
`
`description.
`
`The original patent application describes the invention as a device that is used
`
`with “standard guide catheters” in “interventional cardiology procedures.”
`
`(Ex. 1842, 7-8.) The claims of the original patent application (and the proposed
`
`claims here) are generally directed to the “coaxial guide catheter” described in the
`
`specification. (See, e.g., id., 38-44; see also POR, 4 (also describing the invention
`
`as a “guide extension catheter”).) This coaxial guide catheter is consistently
`
`described as being made of three distinct portions: “a tip portion, a reinforced
`
`portion, and a substantially rigid portion.” (Ex. 1842, 9; see also id., 16
`
`(alternatively describing the final section as a “rigid portion 20”).) Each of these
`
`portions has a specified composition—the tip portion is “a low durometer polymer
`
`or elastomer”; the reinforced portion is made of PTFE, Pebax®, and may be
`
`reinforced with “metallic fibers in a braided or coiled pattern”; and the rigid portion
`
`is “formed from a stainless steel or Nitinol tube.” (Id., 9.)
`
`The only portions of the specification that describe a side opening are in the
`
`parts describing the “rigid portion.” (Id., 9-10, 13-20, 38-41, 43, Figs. 4, 12-16;
`
`see also Ex. 1919, ¶¶ 28-41, 46-47.) Indeed, PO points to these portions as
`
`supporting the “side opening” limitations of the proposed claims. (Mot., 4, 7.)
`
`2
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`For instance, PO frequently points to Figure 4 of the specification as providing
`
`support for the side opening of the claims:
`
`
`
`(Ex. 1001, Fig. 42 (color and annotations added); see Mot. 9-10.). In the figure
`
`above, the alleged “side opening” (boxed in red) is included in the portion
`
`designated by the reference numeral 20, which is the “rigid portion.” (See, e.g.,
`
`Ex. 1842, 16.) Likewise, Figures 12-16 illustrate a side opening in rigid portion
`
`20:
`
`
`2 Petitioner uses the as-issued patent drawing—as opposed to the hand-drawn figures
`
`accompanying the patent application—for continuity with the Petition. The parties
`
`stipulated that each application in the priority chain contains substantively identical
`
`disclosures. (IPR2020-00126, Paper 38, 2 n.1.)
`
`3
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`
`
`(Ex. 1001, Figs. 12-16 (color and annotations added).)
`
`Nowhere does the specification describe a side opening outside of the rigid
`
`portion. (Ex. 1919, ¶¶ 28-36, 46-47.) And the originally filed claims of the ʼ629
`
`application (which are part of the written description) confirm that the side opening
`
`is located in the “substantially rigid portion.” (Ex. 1842, 38 (original claim 1 reciting
`
`a “substantially rigid portion having an opening along a side thereof”), 39 (original
`
`claim 4 reciting “substantially rigid portion . . . comprises a cylindrical portion and
`
`a partially cylindrical portion defining the opening along a side thereof”), 40-41
`
`(similar for original claim 8), 43 (similar for original claim 17); see also
`
`Ex. 1919, ¶¶ 37-41.)
`
`For a claim to have written description support, the specification must
`
`“actually or inherently disclose[] the claim element”; obviousness is not sufficient.
`
`PowerOasis Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008);
`
`4
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`see also Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998). Because
`
`proposed claims 23 and 24 attempt to capture this feature, and the feature is not
`
`supported by the written description (either actually or inherently), proposed claims
`
`23 and 24 are unpatentable. See Gentry Gallery, Inc. v. Berkline Corp.,
`
`134 F.3d 1473, 1479-80 (Fed. Cir. 1998) (rejecting claims that did not limit the
`
`location of the claimed “controls” where “the original disclosure clearly identifies
`
`the console as the only possible location for the controls”).
`
`PO’s Motion largely ignores this glaring defect in the proposed claims,
`
`addressing it only in a single sentence regarding proposed claim 23, asserting “[t]he
`
`claim need not expressly recite that the side opening is in the substantially rigid
`
`portion.” (Mot., 4 (citing Ex. 2124, ¶¶ 30-44, 51); see also id., 7 (ignoring this defect
`
`for the “side opening” limitation in proposed claim 24).) PO’s Motion, however,
`
`provides no rationale for why this is so, and it relies entirely on the arguments made
`
`in its expert’s declaration. Those arguments boil down to two assertions: (1) that the
`
`substantially rigid portion need not be substantially rigid because it can be designed
`
`to be less rigid (Ex. 2124, ¶¶ 32, 36-38, 42), and (2) because the specification
`
`describes alternative proximal openings (e.g., perpendicular end openings), the side
`
`opening need not be in the substantially rigid portion (id., ¶¶ 33-35, 39-40, 42).
`
`These arguments are absent from PO’s motion, but regardless, both are meritless.
`
`5
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`Regarding the first assertion, to the extent PO takes issue with how its own
`
`invention is described (e.g., id., ¶ 36 (“so-called rigid portion”)), it is a problem of
`
`PO’s own making that cannot be cured in an IPR proceeding. The legally relevant
`
`inquiry is whether a POSITA would have understood the inventor(s) to have had
`
`possession of a device with a side opening outside of the substantially rigid portion,
`
`as claimed. PO’s expert fixated on the wrong question: whether the side opening
`
`can be made less rigid despite being in the substantially rigid portion. (Id., ¶ 31;
`
`see also id., ¶ 41.) But he was forced to admit that there is no description of a side
`
`opening in the reinforced portion, and all examples are in rigid portion 20 and were
`
`“cut into a tube of substantially rigid material.” (Ex. 1764, 10:2-18, 23:25-26:18.)
`
`Further, he admitted that the relief cuts he points to are in rigid portion 20.
`
`(Id., 20:4-7.) Whether or not the rigid tubular material of the rigid portion can be
`
`designed to be less rigid is irrelevant. The specification consistently describes the
`
`side opening as being located within a part of the device defined by the original
`
`application as the “rigid portion” or the “substantially rigid portion.” (See, e.g.,
`
`Ex. 1842, 16; see also Ex. 1919, ¶¶ 71-72.)
`
`Regarding the second assertion, PO’s expert opines that the original
`
`application describes a “range of options . . . for the distal tube’s proximal opening,”
`
`but announces only two—a proximal opening perpendicular to the longitudinal axis
`
`(i.e., an end opening) and a side opening extending longitudinally. (Ex. 2124,
`
`6
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`¶¶ 33-35, 39-40, 42.) To begin, PO’s expert’s use of the term “distal tube”—a term
`
`not found in the original application—obfuscates the three distinct portions of the
`
`claimed device as described in the specification. A closer look at the specification,
`
`however, dispels this confusion and confirms that the “side opening” described is
`
`located only in the “rigid portion.” (See, e.g., Ex. 1842, 10, 18, 19.)
`
`PO’s expert points to Figure 21 as an alternative configuration for “the distal
`
`tube’s proximal opening”—an opening perpendicular to the longitudinal axis.
`
`(Ex. 2124, ¶¶ 34, 39.)
`
`
`
`(Ex. 1001, Fig. 21 (annotation added); see also id., Fig. 1 (showing a similar
`
`configuration).)
`
`As admitted by PO’s expert, though, Figure 21 does not show a side opening.
`
`(Ex. 1764, 16:19-24.) For instance, PO distinguished the end opening shown in
`
`Figure 21 from a side opening (i.e., “a cylindrical portion defining an opening along
`
`a side thereof”) during prosecution. (Ex. 1906, 11, 13.) To gain issuance of the ʼ032
`
`patent, PO argued that the below-prior art “disclose[d] no ‘opening along a side’”
`
`and that “[t]hese ends are not generally parallel to a long axis.” (Id., 13.)
`
`7
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`
`
`PO cannot now point to a similar disclosure, Figure 21, to provide written
`
`description support for a side opening. What is more, in past litigation, PO’s expert,
`
`Mr. Keith, distinguished a side opening from the type of opening identified in Figure
`
`21. (Ex. 1825, ¶¶ 81-83.)
`
`In the Figure 21 embodiment, the rigid portion includes no “full
`
`circumference” portion at the rigid portion’s distal end. (Ex. 1919, ¶¶ 73-74.)
`
`Instead, the rigid portion, described as “hemi-tube portion 110,” forms only part of
`
`a cylinder and is “joined to the braided portion 112 [i.e., the ‘reinforced portion’ of
`
`the claims], for example, by adhesive, bonding, or welding.” (Ex. 1842, 22.) The
`
`principal difference between this embodiment and the ones shown in Figure 4 and
`
`Figures 12-16 is that the rigid portion in the Figure 4 and Figures 12-16 embodiments
`
`include a full circumference portion and a side opening. The reinforced portion in
`
`every embodiment is the same, with an opening perpendicular to the longitudinal
`
`axis that is joined to the substantially rigid portion, as illustrated by the boxed
`
`sections below.
`
`8
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`
`
`(Ex. 1001, Figs. 4, 12-13 (annotations added).)
`
`The fact that the rigid portion may or may not include a side opening does not
`
`mean that the specification provides written description of a side opening outside of
`
`the rigid portion, as PO’s expert asserts. (See Ex. 2124, ¶ 35 (identifying the
`
`specification’s permissive language that the “rigid portion may include a cutout
`
`portion and a full circumference portion”) (emphasis original).) Indeed, PO’s expert
`
`himself appeared to draw a distinction between a bare “proximal opening” of the
`
`reinforced portion of the “distal tube,” as shown in Figure 21, and a “side opening,”
`
`as shown in Figures 4 and 12-16. (Ex. 2124, ¶¶ 39-40 (asserting the “distal tube’s
`
`proximal opening … can be perpendicular” or “[i]t also can be a side opening with
`
`various sloped configurations.”).) Importantly, in denying a motion for preliminary
`
`injunction, the District Court rejected PO’s argument that use of the word “may” in
`
`the specification indicated that the location of the side opening could be outside of
`
`the rigid portion. (Ex. 1088, 8.)
`
`9
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`Because there is no support for a side opening outside of the substantially
`
`rigid portion, proposed substitute claims 23 and 24 are unpatentable for lack of
`
`written description support under 35 U.S.C. § 112(a).3 See ICU Medical, Inc. v.
`
`Alaris Medical Sys., Inc., 558 F.3d 1368, 1376-77 (Fed. Cir. 2009) (finding a claim
`
`invalid for lack of written description support when the full claim scope covered
`
`valves with and without spikes but the specification only disclosed valves with
`
`spikes).
`
`
`3 PO’s expert also includes an argument based on the prosecution history of a
`
`different patent—another argument not found in PO’s motion. (Ex. 2124, ¶ 43.) To
`
`the extent this extra argument is even considered, the prosecution history, in fact,
`
`contradicts PO’s argument. The Examiner explicitly rejected the pending claims for
`
`the exact reasons urged by Petitioner here—because the patent “is very clear that the
`
`side opening … is a part of rigid portion 20 and not its own segment apart from the
`
`rigid portion.” (Ex. 1908, 41-42; see also Ex. 1919, ¶¶ 42-45.) And although it is
`
`unclear how PO overcame this rejection (because the Examiner’s notice of
`
`allowance, regrettably, does not address this issue), PO should not be allowed to
`
`recapture this claim scope in this IPR.
`
`10
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`B.
`
`Proposed claims 23-25 are indefinite.
`
`Proposed claim 23 requires that the length of the substantially rigid portion
`
`“when combined with the length of the flexible [] tip portion, defines a total length
`
`of the device.” (App., 1-2.) But the proposed claim now recites a “substantially
`
`rigid side opening” that is outside of both the “flexible tip portion” and the
`
`“substantially rigid portion.” It is unclear how the device can also include such a
`
`“side opening” when the total length of the device is defined by the combination of
`
`“flexible tip portion” and the “substantially rigid portion.” Proposed claim 23 is
`
`therefore indefinite.
`
`Further, proposed claim 24 is indefinite because it recites a “substantially rigid
`
`portion . . . connected to . . . the flexible tip portion,” even though there is an
`
`intervening “reinforced portion.” (App., 2-4.) Based on the plain meaning of the
`
`word “connected,” the claim makes little sense and is indefinite. Accordingly,
`
`proposed claim 25 is also indefinite for this reason based on its dependency to
`
`proposed claim 24.
`
`III. THE PRIOR ART RENDERS PROPOSED CLAIMS 23-25
`UNPATENTABLE
`
`PO’s motion should be denied for another independent reason—the substitute
`
`claims are unpatentable over the prior art.
`
`11
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`A. Claim Construction
`
`No express construction for any terms is necessary except that the term
`
`“coaxial” means that “the axis of the lumen of the guide extension catheter is aligned
`
`in
`
`the same direction as
`
`the axis of
`
`lumen of
`
`the guide catheter.”
`
`(Ex. 1806, ¶¶ 14-26.)
`
`B.
`
`Substitute claims 23-25 are unpatentable over Itou in view of
`Ressemann or Kataishi.
`
`Substitute claims 23 and 24 add to the original claims certain limitations
`
`(e.g., the so-called “complex side opening”). (Mot., 9.) But these additions cannot
`
`overcome the prior art of record. The analysis below focuses on the newly added
`
`limitations while briefly addressing the original limitations, which are thoroughly
`
`addressed by the original Petition and supporting testimonial evidence.
`
`1.
`
`Substitute Claim 23
`
`Itou discloses a suction catheter 2 (“device”) for use with a guiding catheter 1
`
`(“guide catheter”). (Ex. 1007, 5:35-38, 5:43-46, 7:1-23, 7:35-43, Figs. 5-6, 8.) There
`
`is no dispute the guiding catheter 1 is placed in a branch artery and has a continuous
`
`lumen with a proximal end at a hemostatic valve and that interventional cardiology
`
`devices can be inserted therethrough. (Ex. 1900, ¶¶ 12-16, 62-74.) Moreover,
`
`guiding catheter 1 can be 6 French. (Ex. 1007, 5:65-67, 6:47-50; Ex. 1900, ¶¶ 14,
`
`18, 88.)
`
`12
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`Itou’s suction catheter 2 (i.e. “a device”) comprises, in a distal-to-proximal
`
`direction, tubular portion (21) and tip (22) (collectively, “flexible tip portion”) that
`
`are part of tubular member (24). (Ex. 1007, 2:12-21, Fig. 3.) Tubular portion 24
`
`(and therefore, flexible tip portion [21, 22]) have an inner diameter of 1.5 mm
`
`(id., Table 1, 1:59-65), which is larger than 0.056 inches (1.42 mm). (Ex. 1900,
`
`¶¶ 17-18.) It is necessarily the case that interventional cardiology devices
`
`(e.g., PTCA balloons and stents) were insertable through the lumen of Itou’s
`
`“flexible tip portion.” (Ex. 2127, 2; Ex. 1900, ¶ 18.) The entirety of tubular member
`
`24 (which includes what Medtronic maps as the “flexible tip portion”) is a “coaxial
`
`lumen.” (Section III.A, supra.) Finally, proximal of the side opening discussed
`
`below, catheter 2’s wire-like portion 25 forms a “substantially rigid portion” that
`
`defines a rail structure without a lumen. (Ex. 1900, ¶¶ 19-61.)
`
`Complex Side Opening Limitation
`
`Itou discloses tip 23, which includes a proximal side opening 231 that is
`
`“inclined obliquely.” (Ex. 1007, 4:10-15.) As shown in the annotation of Figure 3,
`
`infra Section III.B.1.b., proximal opening 231 extends for a distance from (a) to (b)
`
`along the longitudinal axis of suction catheter 2, which forms a “side opening” to,
`
`inter alia, “assure a large opening area on the proximal end side.” (Id.) Proximal
`
`side opening 231 is “substantially rigid” because it is formed by “obliquely cutting
`
`one end of a metal pipe such as a pipe of stainless steel.” (Id., 4:27-30.)
`
`13
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`While Itou’s side opening 231 does not include “a first inclined region,” “a
`
`second inclined region,” and “a non-inclined concave track” between the first and
`
`second inclined regions, it would have been obvious to modify Itou to include such
`
`features in view of Ressemann or Kataishi. (Ex. 1900, ¶¶ 19, 55-61, 101-18.)
`
`a)
`
`Ressemann Discloses a “Complex Side Opening”
`
`Ressemann discloses an evacuation sheath assembly for treating occluded
`
`vessels and reducing the risk of embolization during vascular interventions.
`
`(Ex. 1008, Abstract.) The assembly includes a guiding catheter, which “may be
`
`positioned within the ostium of the target vessel” (id., 12:26-27), and an evacuation
`
`sheath that is inserted through the guiding catheter and advanced beyond the guiding
`
`catheter’s distal end to treat stenosis. (Id., Abstract; Figs. 6A-6F; 6:18-24;
`
`12:9-14:39.)
`
`(Id., Figs. 6A (showing the guide catheter positioned at the ostium), 6B (showing
`
`the evacuation sheath being extended from the distal end of the guide catheter
`
`
`
`towards the stenosis).)
`
`14
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`In one embodiment, Ressemann’s evacuation sheath includes a support
`
`collar 2141 on the proximal end of the tubular portion of the evacuation sheath.
`
`(Ex. 1900, ¶¶ 20-24.) As shown in Figure 16J, reproduced below, support
`
`collar 2141 includes a concave track that runs from the proximal to the distal end of
`
`the collar. Circumferential portion 2141a fits into the proximal opening of the
`
`tubular portion’s lumen. (Ex. 1008, 24:54-56.)
`
`
`
`(Id., Fig. 16J.)
`
`Collar 2141 has the claimed side opening configuration—at least a first
`
`inclined slope at the proximal end of support collar 2141 (shown as “1” below), a
`
`second inclined slope at the distal end of support collar 2141, (shown as “2” below),
`
`and a
`
`flat, non-inclined
`
`region
`
`in-between.
`
`(Ex. 1800, 166:8-12, 168:9-19
`
`15
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`(identifying two inclines); see also Ex. 1005 ¶ 1384 (IPR2020-00126) (construing
`
`claim term “substantially rigid”).)
`
`
`
`(Ex. 1008, Fig. 16J and schematic of Fig. 16J.)
`
`b) Motivation to Combine Itou and Ressemann
`
`A POSITA would have been motivated to modify Itou’s proximal tip 23 to
`
`incorporate the structure of Ressemann’s support collar 2141 containing the claimed
`
`features of the side opening in substitute claims 23 and 24 (as shown in Figure 3
`
`
`4 Unless otherwise noted, all cites to Ex. 1005 and Ex. 1042 are from
`
`IPR2020-00126. To complete the record—as those expert declarations were not
`
`submitted in IPR2020-00127—they can also be found at the same paragraph number
`
`in Ex. 1909 and Ex. 1910, respectively.
`
`16
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`below) so that Itou’s suction catheter 2 could alternatively be used to deliver
`
`interventional cardiology devices, as disclosed in Ressemann.
`
`
`
`(Ex. 1007, Fig. 3 (modification with support collar 2141 shown in gray).)
`
`Itou teaches placing catheter 2 in precisely the right location to deliver a stent
`
`or balloon catheter. (Ex. 1007, Fig. 6; 5:35-42; 7:16-19; Ex. 1900, ¶ 19.) And a
`
`POSITA would have understood that Itou’s suction catheter lumen was of sufficient
`
`inner diameter to accommodate interventional cardiology devices. A POSITA had
`
`the motivation to modify the suction catheter (2)’s proximal opening with
`
`Ressemann’s collar 2141 because this increased the area for receiving a stent and/or
`
`balloon catheter. (Ex. 1900, ¶¶ 20-61; Ex. 1807, ¶¶ 121-25.)
`
`An additional motivation for modifying Itou with Ressemann’s collar is
`
`explicitly taught in Ressemann. The collar serves to reinforce the proximal opening
`
`of the catheter lumen, as well as provide a flexibility transition between the distal
`
`17
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`tubular structure and the proximal shaft. (Ex. 1008, 24:49-67; Ex. 1900, ¶ 58;
`
`Ex. 1806, ¶ 89; Ex. 1807, ¶ 126-128.)
`
`A POSITA would have looked to Ressemann when modifying Itou because
`
`both references disclose devices that address the same problem—removing coronary
`
`vessel occlusions—in the same way—by using an aspiration catheter, the distal end
`
`of which is extended past a guiding catheter’s distal end, into a coronary artery.
`
`(Ex. 1007, Abstract; 1:13-16; 2:2-5, 29-38; 3:59-63; 5:32-34; Figs. 1A, 1B, 5, 6;
`
`Ex. 1008, Abstract, 6:18-24; 12:9-12, 12:19-30; Figs. 6A, 6B.) A POSITA would
`
`have had a reasonable expectation of success because modifying the side opening of
`
`Itou’s suction catheter to have the structure of Ressemann’s support collar is nothing
`
`more than combining prior art elements according to known methods to yield
`
`predictable results. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007).
`
`c) Kataishi Discloses a “Complex Side Opening”
`
`Kataishi similarly discloses
`
`the claimed “complex side opening.”
`
`(Ex. 1900, ¶¶ 97-108.) Kataishi discloses a suction catheter for removing a
`
`thrombus from a coronary artery. (Ex. 1025, ¶ [0001].) Kataishi’s suction catheter
`
`has a distal opening extending along the longitudinal axis with two inclines and a
`
`non-inclined concave track in-between:
`
`18
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`(Id., Figs. 2, 12, ¶ [0010].) This shape is nearly identical to that taught in the ’032
`
`
`
`
`
`patent in Figure 4 (the figure PO frequently identifies as providing support for this
`
`“complex side opening” limitation):
`
`
`
`(Ex. 1008, Fig. 4.)
`
`One benefit of this side opening design taught by Kataishi is an improvement
`
`in the catheter’s “crossing ability”—the ability to reach a desired target site by
`
`advancing past bends in the vasculature. (Id., Abstract, ¶ [0001]; Ex. 1900,
`
`¶¶ 105-07.) Another benefit taught by Kataishi of the two-incline shape is the
`
`improved ability to receive material in the opening (e.g., an improved ability to
`
`suction thrombi). (Ex. 1025, Abstract [0026]-[0027]; Ex. 1900, ¶ 108.)
`
`d) Motivation to Combine Itou and Kataishi
`
`In light of these benefits, taught by Kataishi, a POSITA would have been
`
`motivated to incorporate the shape of Kataishi’s distal opening in Itou’s proximal tip
`
`19
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`23. (Ex. 1900, ¶¶ 109-18.) Regarding the first benefit, a POSITA would have
`
`recognized that improved crossability is a desirable feature in a proximal opening of
`
`a short tube for the same reasons as it is desirable in the distal opening of such a
`
`tube. (Ex. 1008, 6:52-60 (“The proximal and distal ends 140a, 140b of the
`
`evacuation lumen 140 are preferably angled to allow for smoother passage . . . .”).)
`
`In particular, when retracting the device, the angled features of the Kataishi opening
`
`would provide improved crossability as the proximal end would then be the leading
`
`side.
`
`For the second benefit, a POSITA would have recognized that the improved
`
`ability of an opening to accept material would have been applicable to a proximal
`
`opening accepting interventional cardiology devices in the same way as it improved
`
`Kataishi’s distal end to suction a thrombus. (Ex. 1907, ¶ 119.) Allowing an
`
`improved entry of materials into the lumen of Itou’s suction catheter without
`
`increasing the diameter of the device would have been desirable to a POSITA, who
`
`would have understood that this modification allows the catheter to receive a therapy
`
`catheter and still be advanced to distal locations into the coronary vasculature
`
`(compared to catheters with larger diameters). (Ex. 1025, Abstract, [0026]-[0027],
`
`Fig. 10; Ex. 1055, 6, 10 (disclosing a better ability to load because of shape of distal
`
`opening); Ex. 1900, ¶¶ 108-17; Ex. 1907, ¶¶ 113-15, 119.)
`
`20
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`Thus, a POSITA would have been motivated to modify Itou’s proximal tip 23
`
`to incorporate the shape of Kataishi’s opening to improve crossability of the devices
`
`and to more easily facilitate the entry of interventional cardiology devices.
`
`(Ex. 1900, ¶¶ 109-18; Ex. 1907, ¶¶ 120-22; Ex. 1055, 6.)
`
`A POSITA would have looked to Kataishi to improve Itou because Itou and
`
`Kataishi are all directed at the same problem—removing occlusions from coronary
`
`arteries using, inter alia, a catheter. (Ex. 1007, Abstract; Ex. 1025, Abstract;
`
`Ex. 1907, ¶ 112; Ex. 1900 ¶ 110.) A POSITA would have a reasonable expectation
`
`of success in modifying Itou’s suction catheter with the claimed side opening
`
`features, as taught by Kataishi. (Ex. 1900, ¶¶ 111-17.) Creating two different
`
`inclined slopes in the side opening would have been a routine task when
`
`manufacturing an extension catheter. (Ex. 1907, ¶ 123; Ex. 1050, Fig. 7 (disclosing
`
`double incline, proximal side opening).
`
`Itou’s wire-like portion 25 is a “substantially rigid portion” at least some
`
`portion of which extends proximally through the hemostatic valve when a distal
`
`portion of the “flexible tip portion” (i.e. 21+22) extends distally of the distal end of
`
`guiding catheter 1. (Ex. 1900, ¶¶ 119-28; Ex. 1007, 5:26-46, Figs. 5, 6.)
`
`21
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`2.
`
`Substitute Claim 24
`
`Itou discloses substitute claim 24 for similar reasons discussed above for
`
`substitute claim 23. (Ex. 1900, ¶¶ 75-77, 80-81, 129-136.) The following discussion
`
`focusses on aspects of claim 24 that are different from claim 23.
`
`First, Itou’s suction catheter 2 (i.e. “a device”) is an elongated structure having
`
`an overall length that is longer than that of guiding catheter 1. (Ex. 1007, 2:23-26.)
`
`Itou’s tip 22 is a “flexible tip portion” and tubular body portion 21 is a “reinforced
`
`portion.” (Id., 2:12-21, 2:23-26, Fig. 3.) Tubular portion 24 (and thus “reinforced
`
`portion” 21) has a uniform, fixed cross-sectional outer diameter of 1.72 mm. (Id.)
`
`The entirety of tubular member 24 (which includes what Medtronic maps as the
`
`“flexible tip portion” and the “reinforced portion”) is a “coaxial lumen.” Itou’s
`
`suction catheter 2 further comprises wire-like portion 25 (i.e., “substantially rigid
`
`portion”), proximal of and connected to tip 22. (Id., 2:15-21, Figs 1B, 1E, 5,
`
`5:11-23.) Itou in view of Ressemann or Kataishi discloses the “complex” side
`
`opening limitation for reasons discussed above in Section III.B.1, supra. The side
`
`opening is positioned between the “reinforced portion” and the wire portion 24
`
`(“substantially rigid portion”). (Ex. 1900, ¶¶ 78-80(i).)
`
`While substitute claim 24 additionally recites “the reinforced portion and the
`
`substantially rigid portion assist in resisting forces exerted by the interventional
`
`cardiology devices passed through and beyond the coaxial lumen that would
`
`22
`
`
`
`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
`
`otherwise tend to dislodge the guide catheter from the artery,” no patentable weight
`
`should be given to such “recitation of a new intended use” for structural features
`
`well-known in t
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
