UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`
`Case No.: IPR2020-00129
`U.S. Patent No. RE 45,380E
`______________________________
`
`PETITIONERS’ REPLY
`
`
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`TABLE OF CONTENTS .......................................................................................... ii
`TABLE OF AUTHORITIES ................................................................................... iv
`I.
`INTRODUCTION ........................................................................................... 1
`II.
`CLAIM CONSTRUCTION ............................................................................ 1
`A. Means for receiving and guiding ........................................................... 1
`1.
`Claim 25 overcomes the means-plus-function presumption. ..... 1
`2.
`The corresponding structure is an extension catheter lacking
`PO’s recited structure. ................................................................. 4
`“Interventional Device” ......................................................................... 6
`B.
`III. CLAIM 25 IS ANTICIPATED. ...................................................................... 6
`A.
`Ressemann anticipates claim 25 (Ground I). ........................................ 6
`1.
`Even if a means-plus-function limitation, Ressemann
`anticipates. ................................................................................... 7
`Even if PO’s unnecessary structure is considered, Ressemann
`discloses an equivalent. ............................................................... 7
`Itou anticipates claims 25 & 33 (Ground VII) ....................................10
`B.
`IV. CLAIM 27 IS INVALID. ..............................................................................11
`A.
`Claim 27 is not inventive. ...................................................................11
`B.
`Ressemann’s collar has more than two inclined slopes. .....................12
`C.
`Ressemann renders obvious. ...............................................................15
`1.
`Ressemann renders obvious because collar 2141 has two
`inclines. .....................................................................................15
`Ressemann renders obvious because collar 2141 has three
`inclines. .....................................................................................19
`Ressemann and Kataishi render obvious. ............................................20
`D.
`Itou and Kataishi render obvious. .......................................................23
`E.
`CLAIMS 32 AND 33 ARE OBVIOUS IN VIEW OF RESSEMANN AND
`TAKAHASHI. ...............................................................................................23
`
`2.
`
`2.
`
`V.
`
`ii
`
`

`

`VI. PO’s “Copying” Allegations do not Overcome Petitioner’s Strong
`Obviousness Showing. ...................................................................................24
`A.
`Side openings existed on prior art devices. .........................................25
`B.
`PO’s copying arguments are without merit. ........................................25
`VII. AIA PATENT ................................................................................................27
`VIII. CONCLUSION ..............................................................................................28
`
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC,
`825 F.3d 1373 (Fed. Cir. 2016) .......................................................................... 16
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .......................................................................... 25
`
`Asyst Techs., Inc. v. Empak, Inc.,
`268 F.3d 1364 (Fed. Cir. 2001) .................................................................... 4, 5, 6
`
`Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., Inc.,
`145 F.3d 1303 (Fed. Cir. 1998) ............................................................................ 9
`
`In re Magna Elecs., Inc.,
`611 F. App’x 969 (Fed. Cir. 2015) ..................................................................... 12
`
`In re Mott,
`557 F.2d 266 (C.C.P.A. 1977) ............................................................................ 10
`
`Inventio AG v. Thyssenkrupp Elevator Ams. Corp.,
`649 F.3d 1350 (Fed. Cir. 2011) ............................................................................ 3
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 26
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 12
`
`Odetics, Inc. v. Storage Tech. Corp.,
`185 F.3d 1259 (Fed. Cir. 1999) ........................................................................ 7, 9
`
`Omega Eng’g, Inc. v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003) ............................................................................ 6
`
`RCA Corp. v. Applied Dig. Data Sys.,
`730 F.2d 1440 (Fed. Cir. 1984) .......................................................................... 10
`
`Unidynamics Corp. v. Automatic Prods. Int’l, Ltd.,
`157 F.3d 1311 (Fed. Cir. 1998) ............................................................................ 3
`
`iv
`
`

`

`ZUP, LLC v. Nash Mfg., Inc.,
`ZUP, LLC v. Nash Mfg, Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 24
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 24
`
`
`
`
`
`v
`
`

`

`I.
`
`
`
`INTRODUCTION
`
`Petitioner has overcome the means-plus-function presumption, meaning that
`
`Ressemann anticipates claim 25. Regardless, as explained herein, Ressemann
`
`anticipates that claim. Further, Itou also anticipates because it is capable of
`
`performing the recited functionality of claim 25. Finally, Patent Owner’s (“PO”)
`
`additional arguments against the dependent claims fail, meaning all the Challenged
`
`Claims are invalid.
`
`II. CLAIM CONSTRUCTION
`
`A. Means for receiving and guiding
`
`Following the “means for receiving … and guiding” limitation, “claim 25
`
`provides an extensive recitation of structure.” Paper 22 (“I.D.”), 18. This narration
`
`of structure overcomes the means-plus-function presumption. Paper 1 (“Pet.”), 15-
`
`17. If not overcome, the corresponding structure is a guide extension catheter.
`
`1.
`
`Claim 25 overcomes the means-plus-function presumption.
`
`PO acknowledges the recitation of structure, but argues it “is not sufficient
`
`to perform the second function”—guiding the interventional device deeper into the
`
`branch vessel—because the claim “does not recite that the tip portion and
`
`reinforced portion have a lumen.” Paper 44 (“POR”), 9-10. PO is wrong.
`
`A POSITA looking only at the claims knows that the reinforced portion and
`
`tip portion form a tubular structure having a lumen. First, PO does not dispute that
`
`the claimed side opening has a lumen, arguing only that the lumen of the opening
`
`1
`
`

`

`may terminate prior to the reinforced portion. POR, 10-11; Ex-1825 ¶82. This is
`
`already nonsensical—there is no reason for a side opening if the lumen terminates
`
`into a dead end. Ex-1806 ¶31. Second, PO’s expert construed “side opening” in a
`
`way that confirms what a POSITA already knew: the side opening does not
`
`terminate into a lumenless dead end. Specifically, PO construed “side opening” to
`
`mean an “[a]ngled opening at the proximal end of the tubing of the guide extension
`
`catheter.” Ex-1212, 17. PO’s expert acknowledged that this “language would
`
`indicate that a tubular region [(i.e., a lumen)] is found distal to the side opening.”
`
`Ex-1801, 11:18-12:13. Third, as admitted by inventor Root, “a reinforced portion
`
`… is something that a person with skill in the art would be familiar with” at the
`
`time of the alleged invention. Ex-1762, 54:18-21. Reinforcement was a ubiquitous
`
`feature in this art, and a POSITA knew that it kept a tube from deforming, thereby
`
`maintaining the shape of the lumen. Ex-1806 ¶32. Fourth, a POSITA knows that
`
`the lumen continues through the tip portion because that is the only way to guide a
`
`device into a branch vessel. Ex-1806 ¶33. Mr. Root agreed. Ex-1762, 55:17-21.
`
`Based on the claim language alone, the means-plus-function presumption is
`
`overcome. Ex-1806 ¶¶28-30.
`
` While unnecessary here, it is always appropriate, as noted in the Institution
`
`Decision, to consult the specification regarding the meaning of means-plus-
`
`function claims. I.D., 17-18. Although PO disagrees (POR, 8-9), the Federal
`
`2
`
`

`

`Circuit has repeatedly explained that it will “consider[] the written description to
`
`inform the analysis of whether the claim recites sufficiently definite structure to
`
`overcome the presumption that § 112 ¶6 governs.” Inventio AG v. Thyssenkrupp
`
`Elevator Ams. Corp., 649 F.3d 1350, 1357 (Fed. Cir. 2011); M.P.E.P. § 2181.1
`
`Here, the specification repeatedly recites that the reinforced portion and tip portion
`
`form a tubular structure with a lumen. Ex-1201, 3:50-55, Figs. 1, 3-4. There is
`
`nothing else a “reinforced portion” or “tip portion” could possibly mean in the
`
`context of this specification. Ex-1806 ¶34.
`
`Petitioner is not asking the Board to read any structure into claim 25.
`
`Instead, if the language of claim 25 leaves any doubt, the Board may use the
`
`specification to understand that the claimed reinforced and tip portion have a
`
`lumen. Therefore, Petitioner rebuts the means-plus-function presumption.
`
`
`1 Even the cases PO cites (POR, 10) confirm that the specification can be
`
`consulted. Unidynamics Corp. v. Automatic Prods. Int’l, Ltd., 157 F.3d 1311, 1319
`
`(Fed. Cir. 1998) (“The written description also supports this choice by stating that
`
`‘[t]he spring 46 is an example of spring means tending to keep the door closed.’”).
`
`3
`
`

`

`2.
`
`The corresponding structure is an extension catheter
`lacking PO’s recited structure.
`
`If the means-plus-function presumption is not overcome, then the
`
`corresponding structure is an extension catheter.2 Ex-1806 ¶¶35-36. PO does not
`
`disagree, but instead adds the following structure to that extension catheter:
`
`a distal tubular portion with a single lumen that is coaxial with the
`
`lumen of the guide catheter attached to a substantially rigid rail
`
`structure that allows interventional devices to be advanced alongside
`
`and into the lumen of the tubular portion, with the total length to the
`
`device being longer than the guide catheter, and at least a distal part of
`
`the tubular portion is flexible.
`
`POR, 12. As explained in the Institution Decision, though, PO’s additional
`
`recitation impermissibly attempts to incorporate unnecessary structure from the
`
`specification. I.D., 19-20; Asyst Techs., Inc. v. Empak, Inc., 268 F.3d 1364, 1369-
`
`70 (Fed. Cir. 2001).
`
`
`2 The Petition identified the corresponding structure as a coaxial guide catheter,
`
`which is otherwise known as “an extension catheter.” Pet., 17 n.5; see also id., 1
`
`n.1; Ex-1205 ¶145. This recitation, however, was advanced prior to PO attempting
`
`to recite additional (and unnecessary) structure into the phrase “coaxial guide
`
`catheter.” To avoid confusion, Medtronic’s Reply refers to the corresponding
`
`structure as an “extension catheter.”
`
`4
`
`

`

`PO has not demonstrated that the additional structure is necessary to
`
`accomplish the claimed function of receiving and guiding. Ex-1806 ¶37. In
`
`particular, PO has not shown, because it cannot, that the means for receiving and
`
`guiding cannot be performed unless the extension catheter has a perfectly coaxial
`
`tubular portion and a single lumen.3 Ex-1806 ¶¶38-39. Indeed, PO’s expert
`
`admitted either that he could not “think of a specific reason” or that he had not
`
`“given any particular thought to” the question of whether a non-coaxial, extension
`
`catheter with more than one lumen could perform the function of receiving and
`
`guiding. Ex-1800, 158:10-159:2; Ex-1801, 25:13-25.
`
`PO instead argues that its recitation of structure is appropriate because all
`
`embodiments of the ʼ380 patent have these characteristics. POR, 14-16. PO’s
`
`argument fails, though, because neither the specification nor its experts link the
`
`proposed additional structure—in particular, perfectly coaxial and single lumen—
`
`to the recited function. Asyst Techs., 268 F.3d at 1371 (“The corresponding
`
`structure to a function set forth in a means-plus-function limitation must actually
`
`
`3 PO contends that “coaxial” means that the extension catheter and guide catheter
`
`share a perfect center-of-axis. POR, 18-20. This is an incorrect construction of
`
`coaxial (Ex-1806 ¶¶14-26), but the Board need not address this question because,
`
`as explained herein, PO’s additional recitation of structure is unnecessary.
`
`5
`
`

`

`perform the recited function, not merely enable the pertinent structure to operate as
`
`intended ….”). Indeed, a non-perfectly coaxial catheter with more than one
`
`lumen—for example, Ressemann—can perform the recited receiving and guiding.4
`
`Ex-1806 ¶¶37-38. Thus, the Board should adopt its preliminary analysis and reject
`
`PO’s attempt to “incorporate structure from the written description beyond that
`
`which is necessary to perform the claimed function(s).” I.D., 18-19.
`
`B.
`
`“Interventional Device”
`
`The phrase “interventional device” is not used outside of the claims. A
`
`POSITA would know that the term “interventional device” means any device used
`
`in an interventional procedure. Ex-1806 ¶40. Thus, Itou’s protective catheter 5 is
`
`an “interventional device.” Id.
`
`III. CLAIM 25 IS ANTICIPATED.
`
`A. Ressemann anticipates claim 25 (Ground I).
`
`
`
`The recitation of structure in claim 25 overcomes the means-plus-function
`
`presumption. If so, PO does not dispute that Ressemann anticipates claim 25.
`
`POR, 17-25.
`
`
`4 PO’s recitation of structure also improperly imports a negative limitation—i.e.,
`
`single lumen—into claim 25. Ex-1806 ¶36; see also Omega Eng’g, Inc. v. Raytek
`
`Corp., 334 F.3d 1314, 1322-23 (Fed. Cir. 2003) (declining to add a negative
`
`limitation in the means-plus-function context).
`
`6
`
`

`

`1.
`
`Even if a means-plus-function limitation, Ressemann
`anticipates.
`
`Ressemann’s evacuation assembly 100 performs the function of receiving
`
`and guiding. Pet., 24-25. PO does not disagree, but instead argues that Ressemann
`
`cannot anticipate because its “evacuation sheath does not have a single, coaxial
`
`lumen.” POR, 18. As explained above, this structure is unnecessary to perform the
`
`recited means for receiving and guiding. §II.A.2, supra. Therefore, Ressemann
`
`anticipates. Ex-1205 ¶¶181-85.
`
`2.
`
`Even if PO’s unnecessary structure is considered,
`Ressemann discloses an equivalent.
`
`Even if the Board adopts PO’s additional recitation of structure, Ressemann
`
`anticipates. Ex-1806 ¶¶127-128. Specifically, Ressemann’s evacuation assembly
`
`100 is equivalent to PO’s proposed coaxial guide catheter. Ex-1806 ¶137.
`
`Structural equivalence under § 112 ¶6 is met when the “differences are
`
`insubstantial … that is, if the assertedly equivalent structure performs the claimed
`
`function in substantially the same way to achieve substantially the same result as
`
`the corresponding structure described in the specification.” Odetics, Inc. v. Storage
`
`Tech. Corp., 185 F.3d 1259, 1267 (Fed. Cir. 1999). Here, the claimed function is
`
`“receiving an interventional device … and guiding the interventional device deeper
`
`into the branch vessel.”
`
`7
`
`

`

`PO argues that the “way” the extension catheter of the ʼ380 patent performs
`
`the claimed functions is as follows:
`
`[1] using a combination of the close-fitted “mating” with the interior
`
`of the guide catheter, [2] the distal portion of the coaxial guide
`
`catheter seated deeper in the coronary artery, and [3] back force
`
`applied by the physician to the substantially rigid portion, as needed,
`
`to allow the interventional device to be guided deeper into the branch
`
`artery.
`
`POR, 23-24. As an initial matter, statement [1] recites an unduly restrictive “way.”
`
`Ex-1806 ¶¶129-30. The specification does not mandate any spatial relationship
`
`between the outer wall of the extension catheter and the inner wall of the GC,
`
`expect than the former must be insertable into the latter. Id.; Ex-1201, 8:4-33, 10:5-
`
`7, 10:16-20, Figs. 3, 8-9. Therefore, “way [1] should be amended as follows:
`
`‘using an extension catheter inside a guide catheter.’”Ex-1806 ¶130. Ressemann’s
`
`evacuation assembly is positioned inside the GC, meaning it satisfies the first
`
`“way.”5 Id.; Ex-1208, Fig. 6B. Further, a distal portion of Ressemann’s evacuation
`
`lumen extends into the coronary artery as recited in [2] above. Ex-1806 ¶131.
`
`Finally, a physician applies “back force” to Ressemann’s substantially rigid
`
`
`5 Regardless, Ressemann has a close-fitted mating, as recited in PO’s “way” [1].
`
`Ex-1806 ¶134.
`
`8
`
`

`

`portion, as recited in [3] above, to guide the interventional device into the branch
`
`artery. Ex-1806 ¶¶132-33.
`
`
`
`PO argues, however, that Ressemann’s evacuation assembly 100 must
`
`function differently because it uses two sets of inflatable balloons. POR, 24.
`
`Ressemann, though, never teaches that the inflation balloons facilitate or are
`
`necessary for delivery of an interventional device; rather, the balloons occlude
`
`blood flow when performing a different function: embolic protection. Ex-1806
`
`¶135. Further, PO argues that the way Ressemann “passes interventional devices
`
`deeper into the vasculature is fundamentally different” because the inflated
`
`balloons allegedly provide some form of back-up support. POR, 24-25; Ex-1800,
`
`161:22-162:9. Even if the balloons are for back-up support—they are not (Ex-1806
`
`¶136)—that fact is irrelevant because the claimed function is receiving and
`
`guiding, not providing back-up support. Id. The fact that Ressemann’s balloons
`
`could provide some measure of back-up support—an unclaimed function—is
`
`irrelevant. Odetics, 185 F.3d at 1271 (“That two structures may perform
`
`unrelated—and, more to the point, unclaimed—functions differently or not at all is
`
`simply not pertinent to the measure of § 112 ¶6 equivalents.”); Chiuminatta
`
`Concrete Concepts, Inc. v. Cardinal Indus., Inc., 145 F.3d 1303, 1308 (Fed. Cir.
`
`1998) (same).
`
`9
`
`

`

`
`
`The sealing balloons are irrelevant to Ressemann’s ability to perform the
`
`means for receiving and guiding. Thus, Ressemann anticipates. Ex-1806 ¶137.
`
`B.
`
`Itou anticipates claims 25 & 33 (Ground VII)
`
`
`
`Itou is capable of receiving and guiding interventional devices. Ex-1806
`
`¶¶43-52. Therefore, Itou anticipates claims 25 and 33.
`
`
`
`PO argues that Itou cannot anticipate because (i) Itou does not explicitly
`
`teach receipt of protective catheter 5 from an intermediate or distal portion of the
`
`GC and (ii) protective catheter 5 is not an interventional device. POR, 26-28. PO’s
`
`first argument misapplies the law. Its second argument fails because protective
`
`catheter 5 is an interventional device, but even if not, Itou is capable of receiving
`
`and guiding interventional devices. Ex-1806 ¶¶43-52.
`
`PO believes that Itou cannot anticipate because protective catheter 5 is not
`
`received from an intermediate or distal portion of the GC. The means-plus-function
`
`law does not require this showing. As explained in In re Mott, 557 F.2d 266
`
`(C.C.P.A. 1977), the relevant inquiry in the means-plus-function context is whether
`
`the identified structure is “capable of performing the functional limitation of the
`
`‘means.’” Id. at 269; RCA Corp. v. Applied Dig. Data Sys., 730 F.2d 1440, 1444
`
`(Fed. Cir. 1984) (noting, in the means-plus-function context, that prior art must be
`
`“capable of performing the functional limitation”); M.P.E.P. § 2182 (Aug. 2017).
`
`Because suction catheter 2 (1.5 mm inner diameter) is capable of receiving and
`
`10
`
`

`

`guiding protective catheter 5 (1.35 mm outer diameter) “from an intermediate or
`
`distal portion of the guide catheter,” Itou anticipates. Ex-1806 ¶¶59-62.
`
`
`
`PO does not do so in claim 25, but elsewhere it argues that the “effective
`
`size” of Itou’s opening is 0.046 inches. PO is wrong, Id. ¶¶53-56, but even under
`
`PO’s interpretation, Itou is sized to receive and guide interventional devices, such
`
`as a guidewire, balloon catheter, stent, and stent catheter. Id. ¶¶45-51. Therefore,
`
`Itou anticipates claim 25 and 33. Id. ¶57.
`
`IV. CLAIM 27 IS INVALID.
`
`A. Claim 27 is not inventive.
`
`PO’s inventors and experts admit that the various iterations of the double-
`
`incline configuration are unimportant and provide no benefit over a single incline.
`
`. Ex-1308, 75:12-76:1. Similarly,
`
`
`
`
`
`
`
` Ex-1762, 79:17-80:12;
`
`91:2-19; 115:6-14; 209:2-210:21. And PO’s experts struggled to find any
`
`advantage for the double incline in practice—GuideLiner Version 2 had only a
`
`single incline (Ex-1800, 49:7-14)—or in the patents. Ex-1813, 49:2-3; 98:5-15;
`
`Ex-1800, 39:1-41:18, 49:15-51:21, 55:12-58:15.
`
`11
`
`

`

` The addition of a second incline to the proximal opening constitutes “the
`
`predictable use of prior art elements according to their established functions.” KSR
`
`Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007); In re Magna Elecs., Inc., 611
`
`F. App’x 969, 974 (Fed. Cir. 2015) (finding that “short horizontal lines provide the
`
`same information and functionality as long horizontal lines, and cannot be used as
`
`a distinguishing factor to render the claims nonobvious”). Regardless, as discussed
`
`below, the claimed inclines are present in the art and obvious.
`
`B. Ressemann’s collar has more than two inclined slopes.
`
`PO states that GuideLiner version 1 had three inclines. Thus, Ressemann also
`
`has at least three inclines. Ex-1806 ¶¶120-24.
`
`PO’s expert testified that he identifies where one incline ends and another
`
`begins “just sort of by eye,” explaining that for version 1 of GuideLiner, as
`
`identified below, incline 1 has a “relatively steeper quality” to it, and incline 2 has
`
`“a shallower quality” to it, and “somewhere in between there” is incline 3.
`
`Ex-1800, 45:21-46:2. He believes that even shallow inclines are inclines so long as
`
`they can be identified relative to the catheter’s longitudinal axis. Id., 46:21-47:8.
`
`12
`
`

`

`Ex-1322 (color added to arrows for visibility). Similarly, Root testified that the
`
`figure below has two inclines separated by a flat section. Ex-1762, 91:24-94:1.
`
`
`
`13
`
`

`

`Ex-1316 (bottom annotation added to show inclined regions (red) and flat region
`
`
`
`(blue)).
`
`In light of PO’s testimony, Ressemann’s collar 2141 (“Ressemann’s collar”)
`
`must have more than two inclines. As shown below, Ressemann’s collar has an
`
`incline at the proximal end (“A”), an incline corresponding to the curve between
`
`2121a and 2141b (“C”), and an incline at the curved portion of tab 2141b (“B”).
`
`Ex-1806 ¶121; Ex-2138 ¶¶170.
`
`14
`
`

`

`C. Ressemann renders obvious.
`
`Regardless of whether it has two or three inclines, Ressemann renders claim
`
`
`
`27 obvious.
`
`1.
`
`Ressemann renders obvious because collar 2141 has two
`inclines.
`
`PO does not dispute that Ressemann’s collar, as shown in Figure 16J,
`
`discloses at least two inclines. Ex-1800, 166:8-12, 168:9-19 (identifying inclines
`
`“A” and “C” above). PO argues, however, that “[i]n its fully-assembled state,”
`
`Ressemann has only one inclined slope. POR, 28-29. Dr. Hillstead disagrees.
`
`Ex-2137, 420:20-422:1; see also id., 158:13-22.
`
`Regardless, a POSITA was motivated, with a reasonable expectation of
`
`success, to incorporate Ressemann’s collar into the Figure 1 embodiment. Pet., 46-
`
`47; Ex-1205 ¶¶189-90. PO argues that a POSITA lacked motivation because in its
`
`assembled state, Ressemann does not teach this configuration of Ressemann’s
`
`15
`
`

`

`collar. POR, 36-39. This is not sufficient to overcome Petitioner’s showing of
`
`obviousness. Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825
`
`F.3d 1373, 1380-81 (Fed. Cir. 2016) (explaining that claims can be obvious even if
`
`a prior art combination requires “substantial redesign and reconstruction” of a
`
`reference).
`
`PO actually does not dispute the first motivation to combine Ressemann’s
`
`collar with the Figure 1 embodiment—larger area of entry for devices. PO argues
`
`that not all double incline openings have a larger area of entry, POR, 47-48, but it
`
`is undisputed that Ressemann’s collar does have a larger area that is beneficial for
`
`receiving IVCDs. Compare Pet., 45-47, with POR, 38-42. Petitioner’s proposed
`
`modification to Ressemann’s Figure 1 embodiment—the addition of the
`
`Ressemann collar—would increase the area of entry to almost four times its size.
`
`Ex-1807 ¶¶47-50, 103-110.
`
`
`
`Despite Ressemann explicitly reciting that collar 2141 is a “flexibility
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`transition,” PO argues that a POSITA was not motivated by this teaching because
`
`the Figure 1 embodiment already discloses flexibility transition member 135.
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`POR, 39. But as explained by Mr. Jones, the presence of Ressemann’s collar would
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`only further improve the transition from stiffer hypotube to flexible evacuation
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`16
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`lumen. Ex-1807 ¶¶51-66, 97-103. A POSITA was motivated to make the proposed
`
`modification.6
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`
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`PO also argues that a POSITA “would have recognized the problems”
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`created by placing Ressemann’s support collar above intermediate shaft 120. POR,
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`41-42. Specifically, PO argues that the proposed modification would (i) create a
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`catch-point and (ii) be “complex” because it requires bonding the convex up metal
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`tab to a convex down intermediate shaft. Id. PO’s arguments fail.
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`
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`In support of the former argument, PO presents the following schematic:
`
`
`6 PO also argues that a POSITA was not motivated to add Ressemann’s collar
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`because it would obstruct the lumen of the proximal opening. POR, 40-41. But
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`because Ressemann’s (i) collar is preferably 0.020 inches and (ii) encapsulation
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`material is preferably about 0.004 inches (Ex-1208, 24:10-11, 25:8-11), the
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`marginal increase in profile is outweighed by the resulting improvement in
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`guiding. Ex-1806 ¶125.
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`17
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`

`
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`POR, 41. PO’s figure, though, does not correctly reflect Ressemann’s relative
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`dimensions. Ex-1807 ¶¶67-89; Ex-1800, 177:25-178:8. Further, as is standard
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`practice in the art—and as explicitly taught by Ressemann (Ex-1208, 7:28-39,
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`24:2-10)—support collar 2141 would be encased in a polymer jacket. Ex-1807
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`¶¶90-92. In so doing, as shown in the below schematic, the proposed modification
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`would have no catch-points.
`
`
`
`18
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`Ex-1807 ¶92.
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`
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`PO is also incorrect to argue that the “convex up” and “convex down”
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`arrangement would cause the proposed modification to “pop” loose. Indeed,
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`numerous examples, including those cited on the face of the Teleflex patent (see,
`
`e.g., Ex-1263) disclose catheter assemblies with portions having convex up (distal
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`lumen) and convex down components (pushrod). Ex-1807 ¶¶93-96. Thus, PO is
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`incorrect to argue that there would be no expectation of success. Ressemann and
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`the knowledge of the POSITA renders claim 27 obvious. Ex-1806 ¶126.
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`2.
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`Ressemann renders obvious because collar 2141 has three
`inclines.
`
`
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`PO argues that “if a POSITA was motivated to add Ressemann’s collar 2141
`
`to the embodiment of Figure 1 for the purpose Ressemann actually uses … a
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`POSITA would do it in the way Ressemann teaches, in order to obtain those
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`benefits.” POR, 40. But as shown below, because Ressemann has three inclines,
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`even if incline A was contained within shaft 120, Ressemann still renders obvious.
`
`§ IV.C.1, supra.
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`19
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`
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`Ex-1208, Fig. 1C; Ex-1806 ¶¶118-19.
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`D. Ressemann and Kataishi render obvious.
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`A POSITA was motivated to combine the shape of Kataishi’s distal opening
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`with Ressemann’s proximal opening. Pet., 51-53. Specifically, adding Kataishi’s
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`shape to Ressemann’s proximal opening would improve loading of interventional
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`devices and improve crossability of the catheter. Id. PO is incorrect to argue
`
`otherwise.
`
`PO argues that a POSITA would not recognize that the benefit of Kataishi’s
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`distal opening—“superior loading of thrombus”—applies equally to Ressemann’s
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`proximal opening for loading interventional cardiology devices. POR, 46. PO
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`ignores, though, that Ressemann explicitly teaches that both “[t]he proximal and
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`distal ends 140a, 140b of the evacuation lumen 140 are preferably angled,” and
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`that this shape on either end “allows for larger deformable particulate matter to
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`pass through the lumen more smoothly.” Ex-1208, 6:52-60.
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`20
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`

`
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`Id., Fig. 1A. PO’s own expert, Mr. Keith, is a named inventor on a related patent,
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`which teaches that the “proximal and distal ends … are preferably angled … to
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`facilitate smoother passage of other therapeutic devices.” Ex-1323, 7:54-60
`
`(emphasis added); Ex-1800, 149:3-18; Ex-1208, Figs. 6E, 6G, 13:57-14:26. Thus,
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`Kataishi’s teaching that the shape of its distal tip improves that catheter’s ability to
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`suction thrombus would be understood by a POSITA to also apply to the proximal
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`opening of a catheter such as Ressemann. Ex-1807 ¶133-142, 144; Ex-1806 ¶¶138-
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`41. The shape of Kataishi’s opening increases the area of the proximal opening as
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`compared to Ressemann’s single incline opening. Ex-1807 ¶145.
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`21
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`Id. And an increase in the area of opening makes it easier to introduce a stent or
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`balloon catheter. Ex-1205 ¶¶283-90; Ex-1242 ¶¶104-12; Ex-1807 ¶¶136-138; Ex-
`
`
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`1806 ¶¶138-41.
`
`
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`PO also incorrectly alleges that Kataishi’s “crossability” benefits would not
`
`apply to Ressemann because it does not “see” the vasculature. POR, 45-46. As a
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`threshold matter, Ressemann teaches that both the proximal and distal ends of
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`evacuation lumen 140 assist in ensuring “smoother passage of the evacuation
`
`sheath assembly 100 through a guide catheter.” Ex-1208, 6:52-57 (emphasis
`
`added); Ex-1323, 7:54-60. A POSITA would recognize Kataishi’s distal shape
`
`would also assist devices as they move through the guide catheter. Indeed, as cited
`
`in the Petition, Sakurada performed a “passing ability test” of Kataishi that
`
`measured “[t]he length between the ostium and the distal tip of the aspiration
`
`22
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`catheter.” Ex-1255, 300-02. Sakurada found that Kataishi’s shape had improved
`
`crossability as the catheter advanced along various loops in the vasculature. Id.;
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`Ex-1807 ¶¶139-142, 52-66, 210. A POSITA appreciates that modifying
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`Ressemann’s proximal opening to include the shape of Kataishi’s distal tip was an
`
`obvious modification.
`
`E.
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`Itou and Kataishi render obvious.
`
`
`
`PO raises the same objections to modifying Itou’s proximal opening with the
`
`shape of Kataishi as it did for the corresponding Ressemann-Kataishi combination.
`
`POR, 58-59. These arguments fail for the same reasons. § IV.D, supra.
`
`V. CLAIMS 32 AND 33 ARE OBVIOUS IN VIEW OF RESSEMANN
`AND TAKAHASHI.
`
`PO does not dispute the advantages of removing Ressemann’s sealing
`
`balloons in order to achieve the not-more-than-one-French differential. Compare
`
`Pet., 57-59, with POR, 54-57. Instead, PO argues no motivation to remove
`
`Ressemann’s balloons because that modification would “eliminate Ressemann’s
`
`primary function of embolic protection.” POR, at 54. PO is wrong.
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`Embolic protection, as described by PO’s expert, is “something that prevents
`
`debris from flowing downstream.” Ex-1813, 58:15-18. And as admitted by PO’s
`
`expert, (i) it is possible to “provide embolic protection without aspiration” and (ii)
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`“there are ways to provide embolic protection without the use of balloons.” Id.,
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`162:5-11. More particularly, it was possible—if not preferred (Ex-1811, 1443)—to
`
`23
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`use non-occlusive, distal-protection devices to provide embolic protection.
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`Ex-1806 ¶¶106-116. This is how Ressemann would provide embolic protection
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`after removal of its balloons. Id. Thus, PO’s argument fails, and claims 32-33 are
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`obvious.
`
`VI.